COVID-19
Conditions
Keywords
Adaptive, COVID-19, Efficacy, Multicenter, novel coronavirus, Safety
Brief summary
ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
Detailed description
This study is an adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. This adaptive platform is used to rapidly evaluate different therapeutics in a population of those hospitalized with moderate to severe COVID-19. The platform will provide a common framework sharing a similar population, design, endpoints, and safety oversight. New stages with new therapeutics can be introduced. One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study arms. ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized). The primary outcome is time to recovery by Day 29 for patients with baseline ordinal score 4, 5 and 6. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Each stage may prioritize different secondary endpoints for the purpose of multiple comparison analyses. Contacts: 20-0006 Central Contact Telephone: 1 (301) 7617948 Email: DMIDClinicalTrials@niaid.nih.gov
Interventions
DRUGInterferon beta-1a
Rebif (R) is a purified 166 amino acid human interferon beta glycoprotein with an amino acid sequence identical to natural fibroblast derived human interferon beta. Each 0.5 mL prefilled syringe contains 44 mcg of interferon beta-1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP.
OTHERPlacebo
The interferon beta-1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection.
DRUGRemdesivir
Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Admitted to a hospital with symptoms suggestive of COVID-19. 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. Male or non-pregnant female adult \> / = 18 years of age at time of enrollment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any respiratory specimen or saliva, as documented by either of the following: * PCR or other assay positive in sample collected \< 72 hours prior to randomization; OR * PCR or other assay positive in sample collected \>/= 72 hours but \< 7 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection. Note: if written documentation of the positive test result is not available at enrollment (e.g., report from other institution), the subject may be enrolled but the PCR should be repeated at the time of enrollment. 6. Illness of any duration, and at least one of the following: * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR * SpO2 \< / = 94% on room air, OR * Requiring supplemental oxygen. 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8. Agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day 29.
Exclusion criteria
1. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. Subject meets criteria for ordinal scale category 6 or 7 at the time of screening. 3. Subject has a positive test for influenza virus during this current hospital admission. 4. Subjects with an estimated glomerular filtration rate (eGFR) \< 30 mL/min are excluded unless in the opinion of the PI, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limits of normal. 6. Total white cell blood cell count (WBC) \<1500 cells/microliter. 7. Platelet count \<50,000/microliter. 8. History of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). No laboratory testing is needed. 9. Pregnancy or breast feeding (lactating women who agree to discard breast milk from Day 1 until three weeks after the last study product is given are not excluded). 10. Allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 11. Patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the PI, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 12. Received three or more doses of remdesivir, including the loading dose, outside of the study for COVID-19. 13. Received convalescent plasma or intravenous immunoglobulin \[IVIg\] for the treatment of COVID-19. 14. Received any interferon product within two weeks of screening, either for the treatment of COVID-19 or for a chronic medical condition (e.g., multiple sclerosis, HCV infection). 15. Received any of the following in the two weeks prior to screening as treatment of COVID-19: * Small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); * Monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\], etc.); * Monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19. 16. Prior enrollment in ACTT-3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in C-reactive Protein (CRP) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Creatinine | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in D-dimer Concentration | Days 1, 3, 5, 8, 11, 15, and 29 | Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Hemoglobin | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Prothrombin International Normalized Ratio (INR) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Platelets | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Total Bilirubin | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in White Blood Cell Count (WBC) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Neutrophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Lymphoctyes | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Monocytes | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Basophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Eosinophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change in National Early Warning Score (NEWS) From Baseline | Days 1, 3, 5, 8, 11, 15, 22, and 29 | The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. |
| Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | Day 1 through Day 29 | Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) | Day 1 through Day 29 | An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Duration of Hospitalization | Day 1 through Day 29 | Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Duration of Invasive Mechanical Ventilation | Day 1 through Day 29 | Duration of invasive ventilation was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die |
| Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Day 1 through Day 29 | Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die |
| Duration of New Oxygen Use | Day 1 through Day 29 | Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die |
| Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Day 1 through Day 29 | Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Duration of Non Invasive Ventilation or High Flow Oxygen Use | Day 1 through Day 29 | Duration of non invasive ventilation or high flow oxygen use was measured in days, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Duration of Oxygen Use | Day 1 through Day 29 | Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Day 1 through Day 10 | Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Proportion of Participants With New Non-invasive Ventilation or High Flow Oxygen Use | Day 1 through Day 29 | Proportion of participants with new non-invasive ventilation or high flow oxygen use was assessed as for participants in Ordinal Score 4 and 5. |
| Proportion of Participants With New Oxygen Use | Day 1 through Day 29 | Incidence of new oxygen use was assessed as for participants in Ordinal Score 4 and 5 who were not on oxygen at baseline. |
| Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Day 1 through Day 29 | Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use was assessed among participants not on ventilator or extracorporeal membrane oxygenation (ECMO) use at baseline. |
| Mean Change From Baseline in the Ordinal Scale | Day 1, 3, 5, 8, 11, 15, 22, and 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement. |
| Time to an Improvement of One Category Using an Ordinal Scale | Day 1 through Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Day 15 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Day 1 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Day 3 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Day 5 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Day 8 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Day 11 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Day 15 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Day 22 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| 14-day Participant Mortality | Day 1 through Day 15 | The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates |
| Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First | Day 1 through Day 29 | The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant. |
| Time to Recovery for Patients With a Baseline Ordinal Score of 4 and 5 | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to an Improvement of Two Categories Using an Ordinal Scale | Day 1 through Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant. |
| 28-day Participant Mortality | Day 1 through Day 29 | The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates. |
| Change From Baseline in Alanine Aminotransferase (ALT) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
| Change From Baseline in Aspartate Aminotransferase (AST) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6). |
Countries
Japan, Mexico, Singapore, South Korea, United States
Participant flow
Recruitment details
Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 05AUG2020 and 11NOV2020.
Participants by arm
| Arm | Count |
|---|---|
| Remdesivir Plus Interferon Beta-1a 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. | 487 |
| Remdesivir Plus Placebo 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. | 482 |
| Total | 969 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible after enrollment | 2 | 0 |
| Overall Study | Enrolled but not treated | 8 | 8 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Remdesivir Plus Interferon Beta-1a | Remdesivir Plus Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 186 Participants | 178 Participants | 364 Participants |
| Age, Categorical Between 18 and 65 years | 301 Participants | 304 Participants | 605 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 15.8 | 59.1 years STANDARD_DEVIATION 16.1 | 58.7 years STANDARD_DEVIATION 15.9 |
| Baseline Ordinal Score Ordinal Score 4 | 84 Participants | 68 Participants | 152 Participants |
| Baseline Ordinal Score Ordinal Score 5 | 368 Participants | 380 Participants | 748 Participants |
| Baseline Ordinal Score Ordinal Score 6 | 35 Participants | 34 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 154 Participants | 157 Participants | 311 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 323 Participants | 317 Participants | 640 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 44 Participants | 39 Participants | 83 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 84 Participants | 160 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 54 Participants | 63 Participants | 117 Participants |
| Race (NIH/OMB) White | 299 Participants | 285 Participants | 584 Participants |
| Region of Enrollment Japan | 8 participants | 9 participants | 17 participants |
| Region of Enrollment Mexico | 28 participants | 29 participants | 57 participants |
| Region of Enrollment Singapore | 3 participants | 2 participants | 5 participants |
| Region of Enrollment South Korea | 16 participants | 14 participants | 30 participants |
| Region of Enrollment United States | 432 participants | 428 participants | 860 participants |
| Sex: Female, Male Female | 190 Participants | 216 Participants | 406 Participants |
| Sex: Female, Male Male | 297 Participants | 266 Participants | 563 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 452 | 7 / 35 | 13 / 448 | 4 / 34 |
| other Total, other adverse events | 49 / 442 | 12 / 32 | 45 / 435 | 7 / 31 |
| serious Total, serious adverse events | 65 / 442 | 21 / 32 | 58 / 435 | 8 / 31 |
Outcome results
Primary
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 | 5.0 Days |
p-value: 0.8895% CI: [0.87, 1.13]Log Rank
Primary
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized and for whom Ethnicity was reported. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity | Not Hispanic or Latino | 5.0 Days |
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity | Hispanic or Latino | 6.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity | Not Hispanic or Latino | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Ethnicity | Hispanic or Latino | 5.0 Days |
Comparison: This analysis is for Not Hispanic or Latino participants.95% CI: [0.86, 1.19]
Comparison: This analysis is for Hispanic or Latino participants.95% CI: [0.65, 1.05]
Primary
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Asian | 8.0 Days |
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Black or African American | 4.0 Days |
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | White | 4.0 Days |
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Other | 6.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Other | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Asian | 8.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | White | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Race | Black or African American | 4.0 Days |
Comparison: This analysis is for Asian participants.95% CI: [0.59, 1.45]
Comparison: This analysis is for Black and African American participants.95% CI: [0.66, 1.27]
Comparison: This analysis is for White participants.95% CI: [0.86, 1.21]
Comparison: This analysis is for Race of Other participants95% CI: [0.59, 1.19]
Primary
Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex | Male | 5.0 Days |
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex | Female | 4.5 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex | Male | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Participants With Baseline Ordinal Score 4, 5 and 6 by Sex | Female | 5.0 Days |
Comparison: This analysis is for Male participants.95% CI: [0.78, 1.1]
Comparison: This analysis is for Female participants.95% CI: [0.86, 1.29]
Secondary
14-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates
Time frame: Day 1 through Day 15
Population: The ITT population consists of all participants as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | 14-day Participant Mortality | 0.02 Proportion of participants |
| Remdesivir Plus Placebo | 14-day Participant Mortality | 0.02 Proportion of participants |
Secondary
28-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Time frame: Day 1 through Day 29
Population: The ITT population consists of all participants as randomized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | 28-day Participant Mortality | 0.05 Proportion of participants |
| Remdesivir Plus Placebo | 28-day Participant Mortality | 0.03 Proportion of participants |
Secondary
Change From Baseline in Alanine Aminotransferase (ALT)
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 41.4 Units/Liter (U/L) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | 18.8 Units/Liter (U/L) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 17.6 Units/Liter (U/L) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | -3.2 Units/Liter (U/L) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | 9.9 Units/Liter (U/L) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | 3.5 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | -4.9 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 1.5 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | -9.3 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | 4.0 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 2.6 Units/Liter (U/L) |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | -15.1 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 5.0 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | -6.4 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | 2.6 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 13.5 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | 9.0 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | 5.3 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | -13.8 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 10.9 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 3.8 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | -8.7 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | -11.1 Units/Liter (U/L) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | -17.6 Units/Liter (U/L) |
Secondary
Change From Baseline in Aspartate Aminotransferase (AST)
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -12.6 U/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -10.9 U/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | 13.2 U/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | -10.8 U/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -6.2 U/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | 8.0 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -19.0 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -27.2 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | -5.1 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -10.8 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | -26.3 U/L |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | -11.3 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | -4.6 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | -5.2 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -16.5 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -13.5 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -13.9 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | -15.8 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | -22.2 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -30.8 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | -19.8 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | -10.0 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -26.3 U/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -20.6 U/L |
Secondary
Change From Baseline in Basophils
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 15 | 0.021 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 29 | 0.027 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 5 | 0.002 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 8 | 0.015 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 11 | 0.009 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Basophils | Day 3 | 0.000 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 5 | 0.011 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 3 | 0.003 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 8 | 0.004 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 15 | 0.007 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 29 | 0.049 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 11 | 0.022 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 3 | 0.001 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 5 | 0.009 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 15 | 0.027 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 11 | 0.016 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 29 | 0.031 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Basophils | Day 8 | 0.010 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 29 | 0.028 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 3 | 0.002 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 5 | 0.003 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 8 | 0.007 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 11 | 0.015 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Basophils | Day 15 | 0.022 10^9 cells/liter |
Secondary
Change From Baseline in C-reactive Protein (CRP)
Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a subject died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used.~.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -69.2 mg/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -65.6 mg/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -63.8 mg/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -59.0 mg/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -66.6 mg/L |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -44.3 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -27.8 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -46.5 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -55.6 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -57.4 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -46.6 mg/L |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -36.0 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -70.2 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -58.2 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -65.6 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -40.0 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -66.6 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -63.3 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -76.8 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -75.6 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -37.6 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -40.5 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -69.3 mg/L |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -72.1 mg/L |
Secondary
Change From Baseline in Creatinine
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The measure was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 3 | -0.076 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 5 | -0.122 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 8 | -0.144 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 11 | -0.205 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 15 | -0.049 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Creatinine | Day 29 | -0.075 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 29 | -0.182 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 11 | 0.361 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 3 | 0.054 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 8 | 0.415 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 5 | 0.121 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 15 | 0.099 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 5 | -0.077 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 8 | -0.109 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 11 | -0.103 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 29 | -0.029 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 15 | -0.057 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Creatinine | Day 3 | -0.069 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 15 | 0.178 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 29 | 0.140 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 5 | -0.050 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 11 | -0.004 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 3 | -0.074 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Creatinine | Day 8 | 0.005 mg/dL |
Secondary
Change From Baseline in D-dimer Concentration
Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15, and 29
Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a subject died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 3 | -0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 11 | -0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 15 | -0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 8 | -0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 5 | -0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in D-dimer Concentration | Day 29 | -0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 29 | -8.9 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 8 | -9.9 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 11 | -10.9 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 3 | 2.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 5 | -4.0 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 15 | -9.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 5 | 0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 3 | 0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 29 | 0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 15 | -0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 11 | 0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in D-dimer Concentration | Day 8 | 0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 29 | -0.4 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 3 | 0.5 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 5 | 0.8 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 8 | 0.0 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 11 | -0.3 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in D-dimer Concentration | Day 15 | -0.3 mg/L fibrinogen-equivalent units (FEU) |
Secondary
Change From Baseline in Eosinophils
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 11 | 0.044 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 15 | 0.116 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 3 | 0.011 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 29 | 0.189 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 8 | 0.043 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Eosinophils | Day 5 | 0.016 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 29 | 0.291 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 8 | 0.028 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 11 | 0.117 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 15 | 0.135 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 3 | 0.014 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 5 | 0.037 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 11 | 0.063 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 29 | 0.172 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 3 | 0.013 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 5 | 0.032 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 8 | 0.041 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Eosinophils | Day 15 | 0.130 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 29 | 0.199 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 8 | 0.038 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 3 | 0.006 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 5 | 0.019 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 11 | 0.105 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Eosinophils | Day 15 | 0.166 10^9 cells/liter |
Secondary
Change From Baseline in Hemoglobin
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 15 | -0.58 grams/deciliter (g/dL) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 5 | -0.04 grams/deciliter (g/dL) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 29 | -0.39 grams/deciliter (g/dL) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 8 | -0.34 grams/deciliter (g/dL) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 11 | -0.71 grams/deciliter (g/dL) |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Hemoglobin | Day 3 | -0.19 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 5 | -0.47 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 3 | -0.14 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 8 | -1.13 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 15 | -3.18 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 29 | -3.89 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 11 | -1.98 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 3 | -0.20 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 5 | -0.13 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 15 | -0.43 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 11 | -0.47 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 29 | -0.13 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Hemoglobin | Day 8 | -0.29 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 29 | -1.15 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 3 | -0.10 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 5 | -0.81 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 8 | -1.01 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 11 | -1.32 grams/deciliter (g/dL) |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Hemoglobin | Day 15 | -2.65 grams/deciliter (g/dL) |
Secondary
Change From Baseline in Lymphoctyes
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 5 | 0.492 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 11 | 0.536 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 8 | 0.390 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 3 | 0.301 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 29 | 0.863 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Lymphoctyes | Day 15 | 0.655 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 5 | 0.289 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 8 | 0.281 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 3 | 0.237 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 11 | 0.347 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 15 | 0.384 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Lymphoctyes | Day 29 | 0.575 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 5 | 0.470 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 11 | 0.486 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 29 | 0.909 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 15 | 0.679 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 3 | 0.227 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Lymphoctyes | Day 8 | 0.404 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 5 | 0.242 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 29 | 0.873 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 15 | 0.642 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 11 | 0.867 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 3 | 0.137 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Lymphoctyes | Day 8 | 0.377 10^9 cells/liter |
Secondary
Change From Baseline in Monocytes
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 3 | 0.157 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 5 | 0.229 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 8 | 0.301 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 11 | 0.381 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 15 | 0.207 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Monocytes | Day 29 | 0.131 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 29 | 0.310 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 11 | 0.365 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 3 | 0.112 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 8 | 0.147 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 5 | 0.136 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 15 | 0.107 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 5 | 0.212 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 8 | 0.311 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 11 | 0.403 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 29 | 0.114 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 15 | 0.212 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Monocytes | Day 3 | 0.127 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 15 | 0.262 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 29 | 0.015 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 5 | 0.172 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 11 | 0.333 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 3 | 0.179 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Monocytes | Day 8 | 0.348 10^9 cells/liter |
Secondary
Change From Baseline in Neutrophils
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 3 | -0.622 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 5 | -0.307 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 11 | 2.069 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 15 | -0.383 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 29 | -1.779 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Neutrophils | Day 8 | 0.187 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 8 | 1.712 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 11 | 3.419 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 3 | -0.324 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 29 | -1.867 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 5 | -0.123 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 15 | 1.311 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 8 | 2.583 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 3 | 0.329 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 5 | 1.096 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 11 | 2.612 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 15 | 0.165 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Neutrophils | Day 29 | -1.492 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 29 | -3.317 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 15 | -0.004 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 5 | 0.323 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 8 | 2.312 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 3 | 0.479 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Neutrophils | Day 11 | 1.146 10^9 cells/liter |
Secondary
Change From Baseline in Platelets
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 3 | 46.5 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 5 | 82.1 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 8 | 96.8 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 11 | 70.9 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 15 | 29.4 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Platelets | Day 29 | 56.7 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 29 | 52.4 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 11 | 20.0 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 3 | 38.4 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 8 | 45.2 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 5 | 63.9 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 15 | -40.0 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 5 | 97.8 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 8 | 126.8 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 11 | 98.9 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 29 | 52.3 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 15 | 33.3 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Platelets | Day 3 | 57.6 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 15 | -14.5 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 29 | 4.5 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 5 | 82.2 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 11 | 61.2 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 3 | 58.8 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Platelets | Day 8 | 92.0 10^9 cells/liter |
Secondary
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | -0.09 ratio |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.05 ratio |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | -0.03 ratio |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.07 ratio |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | -0.07 ratio |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | -0.03 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.01 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.02 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | 0.02 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | 0.05 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | 0.00 ratio |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | 0.02 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | 0.07 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | 0.09 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | -0.09 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.04 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.06 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.10 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.02 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | 0.01 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | -0.08 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | -0.08 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.11 ratio |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.05 ratio |
Secondary
Change From Baseline in Total Bilirubin
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 15 | 0.09 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 8 | -0.03 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 5 | -0.07 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 3 | -0.08 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 29 | -0.01 mg/dL |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in Total Bilirubin | Day 11 | 0.00 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 11 | 0.16 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 15 | 0.34 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 3 | 0.07 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 5 | 0.03 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 29 | 0.01 mg/dL |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 8 | 0.10 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 15 | 0.03 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 3 | -0.07 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 11 | 0.09 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 29 | -0.06 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 8 | 0.04 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in Total Bilirubin | Day 5 | 0.00 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 15 | 0.13 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 29 | 0.03 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 3 | 0.03 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 5 | 0.02 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 8 | 0.04 mg/dL |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in Total Bilirubin | Day 11 | -0.01 mg/dL |
Secondary
Change From Baseline in White Blood Cell Count (WBC)
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. The outcome was assessed by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 0.486 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 3.145 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | -0.166 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -0.470 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 1.037 10^9 cells/liter |
| Remdesivir Plus Interferon Beta-1a | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 0.649 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 3.062 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 4.420 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 3.030 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -0.472 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 0.434 10^9 cells/liter |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 0.255 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -0.294 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 0.720 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 1.894 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 3.529 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 3.646 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 1.211 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 3.261 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -2.123 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 1.562 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 0.908 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 0.856 10^9 cells/liter |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 3.153 10^9 cells/liter |
Secondary
Change in National Early Warning Score (NEWS) From Baseline
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
Time frame: Days 1, 3, 5, 8, 11, 15, 22, and 29
Population: The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.7 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.5 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.6 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -1.1 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -1.7 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -1.4 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -1.6 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | 1.6 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | 1.4 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | 1.7 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | 1.9 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | 1.9 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | 1.6 units on a scale |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | 1.0 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -1.4 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.6 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -1.0 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -1.3 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.6 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.6 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -1.9 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -0.6 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -1.8 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.7 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -1.3 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.7 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.5 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -1.0 units on a scale |
Secondary
Duration of Hospitalization
Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The intent-to-treat (ITT) population includes all participants who were randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of Hospitalization | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of Hospitalization | Among participants who did not die | 6 Days |
| Remdesivir Plus Placebo | Duration of Hospitalization | Among participants who did not die | 16.5 Days |
| Remdesivir Plus Placebo | Duration of Hospitalization | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Hospitalization | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Hospitalization | Among participants who did not die | 6 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Hospitalization | Including imputations for participants who died | 10 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Hospitalization | Among participants who did not die | 10 Days |
Secondary
Duration of Invasive Mechanical Ventilation
Duration of invasive ventilation was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were on invasive ventilation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of Invasive Mechanical Ventilation | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of Invasive Mechanical Ventilation | Among participants who did not die | 14 Days |
| Remdesivir Plus Placebo | Duration of Invasive Mechanical Ventilation | Among participants who did not die | 19 Days |
| Remdesivir Plus Placebo | Duration of Invasive Mechanical Ventilation | Including imputations for participants who died | 23 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Invasive Mechanical Ventilation | Among participants who did not die | 14 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Invasive Mechanical Ventilation | Including imputations for participants who died | 26.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Invasive Mechanical Ventilation | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Invasive Mechanical Ventilation | Among participants who did not die | 13.5 Days |
Secondary
Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were not on noninvasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 5 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 4 Days |
| Remdesivir Plus Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 5 Days |
Secondary
Duration of New Oxygen Use
Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of New Oxygen Use | Including imputations for participants who died | 3 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of New Oxygen Use | Among participants who did not die | 3 Days |
| Remdesivir Plus Placebo | Duration of New Oxygen Use | Including imputations for participants who died | 3 Days |
| Remdesivir Plus Placebo | Duration of New Oxygen Use | Among participants who did not die | 3 Days |
Secondary
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 14 Days |
| Remdesivir Plus Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 19 Days |
| Remdesivir Plus Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 23 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 26.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 14 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 13.5 Days |
Secondary
Duration of Non Invasive Ventilation or High Flow Oxygen Use
Duration of non invasive ventilation or high flow oxygen use was measured in days, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to participants who required non invasive ventilation or high flow oxygen use.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 4 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 5 Days |
| Remdesivir Plus Placebo | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 4 Days |
| Remdesivir Plus Placebo | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 5.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Non Invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 4 Days |
Secondary
Duration of Oxygen Use
Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were on oxygen at baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Duration of Oxygen Use | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Interferon Beta-1a | Duration of Oxygen Use | Among participants who did not die | 6 Days |
| Remdesivir Plus Placebo | Duration of Oxygen Use | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Placebo | Duration of Oxygen Use | Among participants who did not die | 27.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Oxygen Use | Among participants who did not die | 7 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Duration of Oxygen Use | Including imputations for participants who died | 7.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Oxygen Use | Among participants who did not die | 20.5 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Duration of Oxygen Use | Including imputations for participants who died | 21.5 Days |
Secondary
Mean Change From Baseline in the Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.
Time frame: Day 1, 3, 5, 8, 11, 15, 22, and 29
Population: The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 15 | -2.5 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 8 | -0.2 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 29 | -2.9 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 11 | -0.4 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 22 | -2.8 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 3 | 0.1 units on a scale |
| Remdesivir Plus Interferon Beta-1a | Mean Change From Baseline in the Ordinal Scale | Day 5 | -0.1 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 22 | -1.3 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 29 | -1.5 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 5 | 0.3 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 8 | 0.3 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 3 | 0.1 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 11 | 0.1 units on a scale |
| Remdesivir Plus Placebo | Mean Change From Baseline in the Ordinal Scale | Day 15 | -0.8 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 11 | -0.4 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 3 | 0.1 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 5 | 0.0 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 22 | -2.8 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 15 | -2.5 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 8 | -0.1 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Mean Change From Baseline in the Ordinal Scale | Day 29 | -3.0 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 29 | -3.2 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 3 | 0.0 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 8 | -0.4 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 11 | -0.6 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 15 | -2.3 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 22 | -2.9 units on a scale |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Mean Change From Baseline in the Ordinal Scale | Day 5 | -0.1 units on a scale |
Secondary
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration
Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated by baseline ordinal scale category (categories 4 and 5 versus category 6).
Time frame: Day 1 through Day 10
Population: The ITT population incudes all participants who were randomized
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 400 Participants |
| Remdesivir Plus Interferon Beta-1a | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Interferon Beta-1a/Placebo | 337 Participants |
| Remdesivir Plus Placebo | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Interferon Beta-1a/Placebo | 13 Participants |
| Remdesivir Plus Placebo | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 25 Participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 382 Participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Interferon Beta-1a/Placebo | 341 Participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 22 Participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Interferon Beta-1a/Placebo | 19 Participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
Time frame: Day 15
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Death at or before study visit | 1.3 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, not on O2, requiring ongoing care | 3.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, on noninvasive vent./high flow O2 | 1.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, not requiring O2, no longer req care | 0.4 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, on invasive mech. vent. or ECMO | 2.2 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Not hospitalized, limit on activities/req home O2 | 53.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, requiring supplemental oxygen | 6.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Not hospitalized, no limitations on activities | 32.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, requiring supplemental oxygen | 6.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Death at or before study visit | 2.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, on invasive mech. vent. or ECMO | 3.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, on noninvasive vent./high flow O2 | 1.8 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Not hospitalized, no limitations on activities | 31.3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, not on O2, requiring ongoing care | 2.5 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Hospitalized, not requiring O2, no longer req care | 0.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 for Participants With Baseline Ordinal Score 4 and 5 | Not hospitalized, limit on activities/req home O2 | 52.5 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 1
Population: The intent-to-treat (ITT) population includes all participants who were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 81.4 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 18.6 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 100 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 84.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 15.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 100 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 11
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 73.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 2.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Death at or before study visit | 0.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 2.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 10.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 5.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 0.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 3.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Death at or before study visit | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 22.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 42.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 5.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 14.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 5.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 0.4 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 12.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Death at or before study visit | 1.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 70.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 3.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 2.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Death at or before study visit | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 11.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 14.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 26.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 38.2 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 15
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Death at or before study visit | 1.3 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 2.2 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 1.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 6.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 3.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 0.4 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 53.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 32.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 31.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 22.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 11.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Death at or before study visit | 14.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 52.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 1.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 6.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 2.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 0.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 31.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Death at or before study visit | 2.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 3.1 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 23.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Death at or before study visit | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 47.1 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 22
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 1.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 0.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 41.6 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 1.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 4.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 48.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Death at or before study visit | 2.2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 22.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 22.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Death at or before study visit | 17.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 20.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 8.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 49.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 1.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 40.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Death at or before study visit | 2.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 4.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 1.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 17.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Death at or before study visit | 11.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 55.9 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 29
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 1.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 0.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 2.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 1.3 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 65.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 24.6 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Death at or before study visit | 3.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Death at or before study visit | 20.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 17.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 31.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 5.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 14.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 2.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 0.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Death at or before study visit | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 67.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 1.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 25.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 70.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 29 | Death at or before study visit | 11.8 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 3
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 0.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 6.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 74.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 18.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.2 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 17.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 80.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 6.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 73.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 18.1 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Death at or before study visit | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 1.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 85.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 5
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Death at or before study visit | 0.2 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 1.8 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 8.4 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 49.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 26.5 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 0.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 13.3 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 37.1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 11.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 48.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Death at or before study visit | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 15.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 8.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 46.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 26.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Death at or before study visit | 0.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 2.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 58.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 20.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 14.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Death at or before study visit | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 8
Population: The intent-to-treat (ITT) population includes all participants who were randomized. Missing values were imputed using Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Death at or before study visit | 0.2 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 2.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 4.4 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 24.1 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 11.9 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 0.7 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 56.0 percentage of participants |
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 2.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 45.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 8.6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 14.3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 22.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Death at or before study visit | 5.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 57.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 7.4 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 21.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 9.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 0.2 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Death at or before study visit | 0.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 2.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 29.4 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 26.5 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 11.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Death at or before study visit | 5.9 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 8.8 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 17.6 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Each Severity Rating on an 8 Point Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Time frame: Day 1 through Day 29
Population: The safety population includes all participants with available data post baseline, analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 38.9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 60.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 31.7 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 36.4 percentage of participants |
95% CI: [0.9, 13.4]
95% CI: [0, 43.9]
Secondary
Percentage of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time frame: Day 1 through Day 29
Population: The safety population includes all participants with available data post baseline, analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 14.7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 60.0 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 13.3 percentage of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 24.2 percentage of participants |
95% CI: [-3.2, 6]
95% CI: [12.3, 54.2]
Secondary
Proportion of Participants With New Non-invasive Ventilation or High Flow Oxygen Use
Proportion of participants with new non-invasive ventilation or high flow oxygen use was assessed as for participants in Ordinal Score 4 and 5.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all Ordinal Score 4 and 5 participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Proportion of Participants With New Non-invasive Ventilation or High Flow Oxygen Use | 0.15 Proportion of participants |
| Remdesivir Plus Placebo | Proportion of Participants With New Non-invasive Ventilation or High Flow Oxygen Use | 0.15 Proportion of participants |
Secondary
Proportion of Participants With New Oxygen Use
Incidence of new oxygen use was assessed as for participants in Ordinal Score 4 and 5 who were not on oxygen at baseline.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants in Ordinal Score 4 and 5 who were randomized and not on oxygen at baseline. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Proportion of Participants With New Oxygen Use | 0.51 Proportion of participants |
| Remdesivir Plus Placebo | Proportion of Participants With New Oxygen Use | 0.57 Proportion of participants |
Secondary
Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use was assessed among participants not on ventilator or extracorporeal membrane oxygenation (ECMO) use at baseline.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 0.04 Proportion of participants |
| Remdesivir Plus Placebo | Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 0.54 Proportion of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 0.05 Proportion of participants |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Proportion of Participants With New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 0.15 Proportion of participants |
Secondary
Time to an Improvement of One Category Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to an Improvement of One Category Using an Ordinal Scale | 12.0 Days |
| Remdesivir Plus Placebo | Time to an Improvement of One Category Using an Ordinal Scale | 15.0 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Time to an Improvement of One Category Using an Ordinal Scale | 12.0 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Time to an Improvement of One Category Using an Ordinal Scale | 5.0 Days |
95% CI: [0.9, 1.19]
95% CI: [0.21, 0.66]
Secondary
Time to an Improvement of Two Categories Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to an Improvement of Two Categories Using an Ordinal Scale | 13.0 Days |
| Remdesivir Plus Placebo | Time to an Improvement of Two Categories Using an Ordinal Scale | NA Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Time to an Improvement of Two Categories Using an Ordinal Scale | 13.0 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Time to an Improvement of Two Categories Using an Ordinal Scale | 14.0 Days |
95% CI: [0.91, 1.19]
95% CI: [0.24, 0.82]
Secondary
Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment, and restricted to those with a baseline NEWS score of 2 or greater.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First | 4.0 Days |
| Remdesivir Plus Placebo | Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First | NA Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5 | Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First | 4.0 Days |
| Remdesivir Plus Placebo in Baseline Ordinal Score 6 | Time to Discharge or to a National Early Warning Score (NEWS) of </= 2 and Maintained for 24 Hours, Whichever Occurs First | 9.0 Days |
95% CI: [0.93, 1.26]
95% CI: [0.21, 0.72]
Secondary
Time to Recovery for Patients With a Baseline Ordinal Score of 4 and 5
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Interferon Beta-1a | Time to Recovery for Patients With a Baseline Ordinal Score of 4 and 5 | 5.0 Days |
| Remdesivir Plus Placebo | Time to Recovery for Patients With a Baseline Ordinal Score of 4 and 5 | 5.0 Days |
95% CI: [0.9, 1.19]