COVID-19
Conditions
Keywords
Adaptive, COVID-19, Efficacy, Multicenter, novel coronavirus, Safety
Brief summary
ACTT-2 will evaluate the combination of baricitinib 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-2 will evaluate the combination of baricitinib 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. 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
OTHERPlacebo
The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet.
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.
DRUGBaricitinib
Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
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 specimen, as documented by either of the following: * PCR positive in sample collected \< 72 hours prior to randomization; OR * PCR positive in sample collected \>/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 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, OR * Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 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 for the treatment of COVID-19 through Day 29.
Exclusion criteria
1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal. 2. Estimated glomerular filtration rate (eGFR) \< 30 ml/min or patient is receiving hemodialysis or hemofiltration at time of screening. 3. Neutropenia (absolute neutrophil count \<1000 cells/microliter) (\<1.0 x 103/microliter or \<1.0 GI/L). 4. Lymphopenia (absolute lymphocyte count \<200 cells/microliter) (\<0.20 x 103/microliter or \<0.20 GI/L) 5. Pregnancy or breast feeding. 6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 7. Allergy to any study medication. 8. Received three or more doses of remdesivir, including the loading dose, outside of the study under the EUA (or similar mechanism) for COVID-19. 9. Received convalescent plasma or intravenous immunoglobulin \[IVIg\]) for COVID-19, the current illness for which they are being enrolled. 10. Received small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatibib, genfinitib), in the 1 week prior to screening 11. Received monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening. 12. Received monoclonal antibodies targeting B-cell (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening. 13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger than the risk of COVID-19. 14. Received \>/= 20 mg/day of prednisone or equivalent for \>/=14 consecutive days in the 4 weeks prior to screening. 15. Use of probenecid that cannot be discontinued at study enrollment. 16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required). 17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects. 19. Have a history of VTE (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 12 weeks prior to screening or have a history of recurrent (\>1) VTE (DVT/PE). 20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery | 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 Recovery 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, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to Recovery 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, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
| Time to Recovery 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, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change From Baseline in Neutrophils | Days 1, 3, 5, 8, 11, 15 and 29 | BBlood 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. |
| Change From Baseline in Lymphocytes | 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. |
| 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. |
| 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. |
| 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. |
| 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 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 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. |
| Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Day 1 through Day 14 | Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo. |
| Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Day 1 through Day 29 | The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline |
| Percentage of Participants Requiring New Oxygen Use | Day 1 through Day 29 | The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline |
| Mean Change 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: 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. A positive change indicates a worsening and a negative change is an improvement. |
| Percentage of Participants at Each Clinical Status Using 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. 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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 at Each Clinical Status Using 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. |
| 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. |
| 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 |
| 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 |
| Time to Discharge or to a NEWS of 2 or Less 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. |
| Change From Baseline in Alanine Transaminase (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. |
| 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 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. |
| Change From Baseline in Aspartate Transaminase (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. |
| 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. |
| Change From Baseline in Glucose | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate serum glucose 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. |
Countries
Denmark, Japan, Mexico, Singapore, South Korea, Spain, United Kingdom, 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 08May2020 and 01Jul2020.
Participants by arm
| Arm | Count |
|---|---|
| Remdesivir Plus Baricitinib 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 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course. | 515 |
| 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 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course. | 518 |
| Total | 1,033 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Became ineligible after enrollment | 1 | 1 |
| Overall Study | Death | 23 | 36 |
| Overall Study | Enrolled but treatment not administered | 7 | 9 |
| Overall Study | Lost to Follow-up | 40 | 41 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Scheduling error | 1 | 2 |
| Overall Study | Transferred to another hospital | 1 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 16 |
Baseline characteristics
| Characteristic | Remdesivir Plus Baricitinib | Total | Remdesivir Plus Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 147 Participants | 305 Participants | 158 Participants |
| Age, Categorical Between 18 and 65 years | 368 Participants | 728 Participants | 360 Participants |
| Age, Continuous | 55.0 years STANDARD_DEVIATION 15.4 | 55.4 years STANDARD_DEVIATION 15.7 | 55.8 years STANDARD_DEVIATION 16 |
| Disease severity Moderate Disease Severity | 339 Participants | 666 Participants | 327 Participants |
| Disease severity Severe Disease Severity | 176 Participants | 367 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 263 Participants | 531 Participants | 268 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 246 Participants | 486 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 49 Participants | 101 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 156 Participants | 79 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 132 Participants | 259 Participants | 127 Participants |
| Race (NIH/OMB) White | 251 Participants | 496 Participants | 245 Participants |
| Region of Enrollment Denmark | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment Japan | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Mexico | 35 Participants | 68 Participants | 33 Participants |
| Region of Enrollment Singapore | 22 Participants | 44 Participants | 22 Participants |
| Region of Enrollment South Korea | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment Spain | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 441 Participants | 885 Participants | 444 Participants |
| Sex: Female, Male Female | 196 Participants | 381 Participants | 185 Participants |
| Sex: Female, Male Male | 319 Participants | 652 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 515 | 37 / 518 |
| other Total, other adverse events | 147 / 507 | 164 / 509 |
| serious Total, serious adverse events | 88 / 507 | 109 / 509 |
Outcome results
Primary
Time to Recovery
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 intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to Recovery | 7.0 Days |
| Remdesivir Plus Placebo | Time to Recovery | 8.0 Days |
p-value: 0.04795% CI: [1, 1.31]Log Rank
Primary
Time to Recovery 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, 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 intent-to-treat (ITT) population includes all participants who were randomized and for whom ethnicity was reported
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Time to Recovery by Ethnicity | Not Hispanic or Latino | 7.0 Days |
| Remdesivir Plus Baricitinib | Time to Recovery by Ethnicity | Hispanic or Latino | 7.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Ethnicity | Not Hispanic or Latino | 9.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Ethnicity | Hispanic or Latino | 7.0 Days |
Comparison: This analysis is for Not Hispanic or Latino participants95% CI: [1.08, 1.6]
Comparison: This analysis is for Hispanic or Latino participants.95% CI: [0.89, 1.31]
Primary
Time to Recovery 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, 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 intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Time to Recovery by Race | Asian | 10 Days |
| Remdesivir Plus Baricitinib | Time to Recovery by Race | Black or African American | 7.0 Days |
| Remdesivir Plus Baricitinib | Time to Recovery by Race | White | 7.0 Days |
| Remdesivir Plus Baricitinib | Time to Recovery by Race | Other | 7.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Race | Other | 8.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Race | Asian | 10.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Race | White | 7.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Race | Black or African American | 6.0 Days |
Comparison: This analysis is for Asian participants.95% CI: [0.73, 1.68]
Comparison: This analysis is for Black or African American participants.95% CI: [0.75, 1.5]
Comparison: This analysis is for White participants.95% CI: [0.93, 1.37]
Comparison: This analysis is for Race of Other participants.95% CI: [1.03, 1.74]
Primary
Time to Recovery 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, 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 intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Time to Recovery by Sex | Male | 7.0 Days |
| Remdesivir Plus Baricitinib | Time to Recovery by Sex | Female | 7.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Sex | Male | 9.0 Days |
| Remdesivir Plus Placebo | Time to Recovery by Sex | Female | 7.0 Days |
Comparison: This analysis is for Male participants.95% CI: [1.04, 1.46]
Comparison: This analysis is for Female participants.95% CI: [0.85, 1.32]
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 Baricitinib | 14-day Participant Mortality | 0.02 proportion of participants |
| Remdesivir Plus Placebo | 14-day Participant Mortality | 0.03 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 includes all participants as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | 28-day Participant Mortality | 0.05 proportion of participants |
| Remdesivir Plus Placebo | 28-day Participant Mortality | 0.08 proportion of participants |
Secondary
Change From Baseline in Alanine Transaminase (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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 3 | 3.3 Units/Liter (U/L) | Standard Deviation 37.1 |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 5 | 16.8 Units/Liter (U/L) | Standard Deviation 104.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 8 | 7.9 Units/Liter (U/L) | Standard Deviation 45.2 |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 11 | 0.0 Units/Liter (U/L) | Standard Deviation 37.5 |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 15 | 5.0 Units/Liter (U/L) | Standard Deviation 61.5 |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Transaminase (ALT) | Day 29 | -5.4 Units/Liter (U/L) | Standard Deviation 43 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 15 | 3.9 Units/Liter (U/L) | Standard Deviation 55.1 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 3 | 2.0 Units/Liter (U/L) | Standard Deviation 30.1 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 11 | 7.3 Units/Liter (U/L) | Standard Deviation 70.2 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 5 | 8.8 Units/Liter (U/L) | Standard Deviation 40.9 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 29 | 2.3 Units/Liter (U/L) | Standard Deviation 116.1 |
| Remdesivir Plus Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 8 | 7.8 Units/Liter (U/L) | Standard Deviation 46.9 |
Secondary
Change From Baseline in Aspartate Transaminase (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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 3 | 3.1 Units/Liter (U/L) | Standard Deviation 72.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 5 | 27.4 Units/Liter (U/L) | Standard Deviation 413.1 |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 8 | -5.6 Units/Liter (U/L) | Standard Deviation 38.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 11 | -10.6 Units/Liter (U/L) | Standard Deviation 46.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 15 | -6.0 Units/Liter (U/L) | Standard Deviation 110.1 |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Transaminase (AST) | Day 29 | -17.1 Units/Liter (U/L) | Standard Deviation 46.7 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 15 | -3.9 Units/Liter (U/L) | Standard Deviation 91 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 3 | 2.4 Units/Liter (U/L) | Standard Deviation 126.4 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 11 | 6.4 Units/Liter (U/L) | Standard Deviation 208.3 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 5 | 2.8 Units/Liter (U/L) | Standard Deviation 48.3 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 29 | 2.4 Units/Liter (U/L) | Standard Deviation 291.1 |
| Remdesivir Plus Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 8 | -4.3 Units/Liter (U/L) | Standard Deviation 42.3 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 3 | 0.000 10^9 cells/liter | Standard Deviation 0.039 |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 5 | 0.007 10^9 cells/liter | Standard Deviation 0.07 |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 8 | 0.011 10^9 cells/liter | Standard Deviation 0.055 |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 11 | 0.014 10^9 cells/liter | Standard Deviation 0.063 |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 15 | 0.026 10^9 cells/liter | Standard Deviation 0.085 |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 29 | 0.022 10^9 cells/liter | Standard Deviation 0.045 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 15 | 0.037 10^9 cells/liter | Standard Deviation 0.104 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 3 | 0.001 10^9 cells/liter | Standard Deviation 0.05 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 11 | 0.022 10^9 cells/liter | Standard Deviation 0.063 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 5 | 0.006 10^9 cells/liter | Standard Deviation 0.044 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 29 | 0.036 10^9 cells/liter | Standard Deviation 0.092 |
| Remdesivir Plus Placebo | Change From Baseline in Basophils | Day 8 | 0.017 10^9 cells/liter | Standard Deviation 0.075 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -23.035 mg/L | Standard Deviation 169.442 |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -58.935 mg/L | Standard Deviation 110.364 |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -78.411 mg/L | Standard Deviation 104.943 |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -103.789 mg/L | Standard Deviation 124.751 |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -122.339 mg/L | Standard Deviation 110.502 |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -131.333 mg/L | Standard Deviation 115.243 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -112.588 mg/L | Standard Deviation 155.762 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -18.671 mg/L | Standard Deviation 102.661 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -88.881 mg/L | Standard Deviation 159.184 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -30.908 mg/L | Standard Deviation 150.076 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -122.342 mg/L | Standard Deviation 268.733 |
| Remdesivir Plus Placebo | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -62.038 mg/L | Standard Deviation 125.254 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 3 | -0.036 milligrams/deciliter (mg/dL) | Standard Deviation 0.465 |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 5 | -0.078 milligrams/deciliter (mg/dL) | Standard Deviation 0.475 |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 8 | -0.082 milligrams/deciliter (mg/dL) | Standard Deviation 0.57 |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 11 | -0.055 milligrams/deciliter (mg/dL) | Standard Deviation 0.798 |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 15 | -0.042 milligrams/deciliter (mg/dL) | Standard Deviation 0.714 |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 29 | -0.034 milligrams/deciliter (mg/dL) | Standard Deviation 0.678 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 15 | 0.094 milligrams/deciliter (mg/dL) | Standard Deviation 0.662 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 3 | -0.019 milligrams/deciliter (mg/dL) | Standard Deviation 0.362 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 11 | 0.194 milligrams/deciliter (mg/dL) | Standard Deviation 1.037 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 5 | 0.001 milligrams/deciliter (mg/dL) | Standard Deviation 0.556 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 29 | 0.033 milligrams/deciliter (mg/dL) | Standard Deviation 0.511 |
| Remdesivir Plus Placebo | Change From Baseline in Creatinine | Day 8 | 0.129 milligrams/deciliter (mg/dL) | Standard Deviation 0.958 |
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 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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 3 | -0.374 mg/L | Standard Deviation 7.062 |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 5 | 0.053 mg/L | Standard Deviation 10.968 |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 8 | -0.271 mg/L | Standard Deviation 9.994 |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 11 | 0.622 mg/L | Standard Deviation 12.779 |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 15 | -0.988 mg/L | Standard Deviation 11.352 |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 29 | 0.774 mg/L | Standard Deviation 27.229 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 15 | -0.422 mg/L | Standard Deviation 6.579 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 3 | 0.384 mg/L | Standard Deviation 5.663 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 11 | 0.309 mg/L | Standard Deviation 7.283 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 5 | -0.149 mg/L | Standard Deviation 5.978 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 29 | -0.219 mg/L | Standard Deviation 10.386 |
| Remdesivir Plus Placebo | Change From Baseline in D-dimer Concentration | Day 8 | 0.351 mg/L | Standard Deviation 5.387 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 3 | 0.050 10^9 cells/liter | Standard Deviation 0.135 |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 5 | 0.104 10^9 cells/liter | Standard Deviation 0.402 |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 8 | 0.088 10^9 cells/liter | Standard Deviation 0.126 |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 11 | 0.078 10^9 cells/liter | Standard Deviation 0.119 |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 15 | 0.121 10^9 cells/liter | Standard Deviation 0.231 |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 29 | 0.192 10^9 cells/liter | Standard Deviation 0.171 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 15 | 0.109 10^9 cells/liter | Standard Deviation 0.163 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 3 | 0.039 10^9 cells/liter | Standard Deviation 0.201 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 11 | 0.115 10^9 cells/liter | Standard Deviation 0.299 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 5 | 0.075 10^9 cells/liter | Standard Deviation 0.257 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 29 | 0.205 10^9 cells/liter | Standard Deviation 0.267 |
| Remdesivir Plus Placebo | Change From Baseline in Eosinophils | Day 8 | 0.086 10^9 cells/liter | Standard Deviation 0.232 |
Secondary
Change From Baseline in Glucose
Blood to evaluate serum glucose 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 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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 3 | -17.1 mg/dL | Standard Deviation 56.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 5 | -15.9 mg/dL | Standard Deviation 59.7 |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 8 | -16.8 mg/dL | Standard Deviation 78.9 |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 11 | -8.1 mg/dL | Standard Deviation 72.3 |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 15 | -11.1 mg/dL | Standard Deviation 69.8 |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 29 | -4.6 mg/dL | Standard Deviation 66.5 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 15 | 0.8 mg/dL | Standard Deviation 68.3 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 3 | -6.0 mg/dL | Standard Deviation 54 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 11 | 1.2 mg/dL | Standard Deviation 66.2 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 5 | -1.6 mg/dL | Standard Deviation 58.4 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 29 | -2.2 mg/dL | Standard Deviation 60.3 |
| Remdesivir Plus Placebo | Change From Baseline in Glucose | Day 8 | 5.0 mg/dL | Standard Deviation 73.7 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 3 | -0.46 grams/deciliter (g/dL) | Standard Deviation 1.05 |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 5 | -0.62 grams/deciliter (g/dL) | Standard Deviation 1.23 |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 8 | -0.93 grams/deciliter (g/dL) | Standard Deviation 1.61 |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 11 | -1.29 grams/deciliter (g/dL) | Standard Deviation 1.85 |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 15 | -0.96 grams/deciliter (g/dL) | Standard Deviation 1.87 |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 29 | -0.54 grams/deciliter (g/dL) | Standard Deviation 1.87 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 15 | -1.12 grams/deciliter (g/dL) | Standard Deviation 2.38 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 3 | -0.34 grams/deciliter (g/dL) | Standard Deviation 1.51 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 11 | -1.62 grams/deciliter (g/dL) | Standard Deviation 1.88 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 5 | -0.64 grams/deciliter (g/dL) | Standard Deviation 1.13 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 29 | -0.77 grams/deciliter (g/dL) | Standard Deviation 2.25 |
| Remdesivir Plus Placebo | Change From Baseline in Hemoglobin | Day 8 | -1.08 grams/deciliter (g/dL) | Standard Deviation 1.47 |
Secondary
Change From Baseline in Lymphocytes
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 3 | 0.503 10^9 cells/liter | Standard Deviation 2.29 |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 5 | 0.620 10^9 cells/liter | Standard Deviation 2.54 |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 8 | 0.515 10^9 cells/liter | Standard Deviation 2.094 |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 11 | 0.541 10^9 cells/liter | Standard Deviation 1.204 |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 15 | 0.687 10^9 cells/liter | Standard Deviation 1.579 |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 29 | 0.653 10^9 cells/liter | Standard Deviation 1.293 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 15 | 0.718 10^9 cells/liter | Standard Deviation 1.684 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 3 | 0.074 10^9 cells/liter | Standard Deviation 3.844 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 11 | 0.409 10^9 cells/liter | Standard Deviation 0.709 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 5 | 0.205 10^9 cells/liter | Standard Deviation 3.838 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 29 | 0.927 10^9 cells/liter | Standard Deviation 1.996 |
| Remdesivir Plus Placebo | Change From Baseline in Lymphocytes | Day 8 | 0.304 10^9 cells/liter | Standard Deviation 1.366 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 3 | 0.004 10^9 cells/liter | Standard Deviation 0.81 |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 5 | 0.094 10^9 cells/liter | Standard Deviation 1.053 |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 8 | 0.105 10^9 cells/liter | Standard Deviation 0.948 |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 11 | 0.210 10^9 cells/liter | Standard Deviation 0.439 |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 15 | 0.256 10^9 cells/liter | Standard Deviation 0.591 |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 29 | 0.108 10^9 cells/liter | Standard Deviation 0.434 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 15 | 0.329 10^9 cells/liter | Standard Deviation 0.606 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 3 | 0.062 10^9 cells/liter | Standard Deviation 0.75 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 11 | 0.378 10^9 cells/liter | Standard Deviation 0.512 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 5 | 0.153 10^9 cells/liter | Standard Deviation 1.013 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 29 | 0.212 10^9 cells/liter | Standard Deviation 0.745 |
| Remdesivir Plus Placebo | Change From Baseline in Monocytes | Day 8 | 0.279 10^9 cells/liter | Standard Deviation 0.758 |
Secondary
Change From Baseline in Neutrophils
BBlood 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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 3 | -1.925 10^9 cells/liter | Standard Deviation 6.234 |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 5 | -1.334 10^9 cells/liter | Standard Deviation 8.092 |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 8 | -0.813 10^9 cells/liter | Standard Deviation 9.695 |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 11 | -0.046 10^9 cells/liter | Standard Deviation 8.881 |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 15 | -1.192 10^9 cells/liter | Standard Deviation 7.844 |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 29 | -1.708 10^9 cells/liter | Standard Deviation 6.735 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 15 | 1.414 10^9 cells/liter | Standard Deviation 7.995 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 3 | -0.333 10^9 cells/liter | Standard Deviation 2.787 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 11 | 1.847 10^9 cells/liter | Standard Deviation 5.152 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 5 | -0.204 10^9 cells/liter | Standard Deviation 3.63 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 29 | -0.656 10^9 cells/liter | Standard Deviation 4.205 |
| Remdesivir Plus Placebo | Change From Baseline in Neutrophils | Day 8 | 1.139 10^9 cells/liter | Standard Deviation 6.665 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 3 | 55.9 10^9 cells/liter | Standard Deviation 54 |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 5 | 116.6 10^9 cells/liter | Standard Deviation 87.8 |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 8 | 197.9 10^9 cells/liter | Standard Deviation 137.4 |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 11 | 229.9 10^9 cells/liter | Standard Deviation 156 |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 15 | 175.9 10^9 cells/liter | Standard Deviation 158.8 |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 29 | 16.5 10^9 cells/liter | Standard Deviation 95.8 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 15 | 111.6 10^9 cells/liter | Standard Deviation 134.9 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 3 | 52.6 10^9 cells/liter | Standard Deviation 51.6 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 11 | 145.7 10^9 cells/liter | Standard Deviation 146.4 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 5 | 106.1 10^9 cells/liter | Standard Deviation 86.9 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 29 | 36.9 10^9 cells/liter | Standard Deviation 107.9 |
| Remdesivir Plus Placebo | Change From Baseline in Platelets | Day 8 | 158.9 10^9 cells/liter | Standard Deviation 128.5 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | -0.03 ratio | Standard Deviation 1.13 |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | 0.02 ratio | Standard Deviation 1.25 |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.01 ratio | Standard Deviation 0.96 |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.04 ratio | Standard Deviation 0.65 |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | -0.04 ratio | Standard Deviation 0.25 |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.12 ratio | Standard Deviation 0.55 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | -0.08 ratio | Standard Deviation 0.91 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | 0.05 ratio | Standard Deviation 0.59 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.03 ratio | Standard Deviation 1.04 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | 0.08 ratio | Standard Deviation 0.65 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.03 ratio | Standard Deviation 0.99 |
| Remdesivir Plus Placebo | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.08 ratio | Standard Deviation 0.98 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 3 | -0.06 mg/dL | Standard Deviation 0.32 |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 5 | -0.04 mg/dL | Standard Deviation 0.37 |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 8 | -0.06 mg/dL | Standard Deviation 0.41 |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 11 | -0.08 mg/dL | Standard Deviation 0.43 |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 15 | -0.10 mg/dL | Standard Deviation 0.37 |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 29 | -0.10 mg/dL | Standard Deviation 0.36 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 15 | 0.08 mg/dL | Standard Deviation 1.2 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 3 | -0.01 mg/dL | Standard Deviation 0.43 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 11 | 0.08 mg/dL | Standard Deviation 1.19 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 5 | 0.01 mg/dL | Standard Deviation 0.42 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 29 | 0.01 mg/dL | Standard Deviation 0.91 |
| Remdesivir Plus Placebo | Change From Baseline in Total Bilirubin | Day 8 | 0.01 mg/dL | Standard Deviation 0.66 |
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.
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | -0.831 10^9 cells/liter | Standard Deviation 3.02 |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | -0.276 10^9 cells/liter | Standard Deviation 3.399 |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 0.663 10^9 cells/liter | Standard Deviation 4.006 |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 1.869 10^9 cells/liter | Standard Deviation 5.683 |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 0.694 10^9 cells/liter | Standard Deviation 5.125 |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -0.364 10^9 cells/liter | Standard Deviation 4.532 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 2.162 10^9 cells/liter | Standard Deviation 5.741 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | -0.037 10^9 cells/liter | Standard Deviation 2.588 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 2.938 10^9 cells/liter | Standard Deviation 5.419 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 0.392 10^9 cells/liter | Standard Deviation 3.238 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | 0.712 10^9 cells/liter | Standard Deviation 4.176 |
| Remdesivir Plus Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 1.606 10^9 cells/liter | Standard Deviation 4.536 |
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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -1.5 units on a scale | Standard Deviation 2.9 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -2.1 units on a scale | Standard Deviation 3.3 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -0.9 units on a scale | Standard Deviation 2.8 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -2.0 units on a scale | Standard Deviation 3.8 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -1.8 units on a scale | Standard Deviation 3.2 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -2.2 units on a scale | Standard Deviation 4.3 |
| Remdesivir Plus Baricitinib | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.5 units on a scale | Standard Deviation 2.5 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -1.4 units on a scale | Standard Deviation 5 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.1 units on a scale | Standard Deviation 2.6 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -0.4 units on a scale | Standard Deviation 2.8 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -0.8 units on a scale | Standard Deviation 3.3 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -1.1 units on a scale | Standard Deviation 3.5 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.2 units on a scale | Standard Deviation 3.9 |
| Remdesivir Plus Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.2 units on a scale | Standard Deviation 4.6 |
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 Baricitinib | Duration of Hospitalization | Including imputation for participants who died | 8 Days |
| Remdesivir Plus Baricitinib | Duration of Hospitalization | Restricted to participants who did not die | 8 Days |
| Remdesivir Plus Placebo | Duration of Hospitalization | Including imputation for participants who died | 8 Days |
| Remdesivir Plus Placebo | Duration of Hospitalization | Restricted to participants who did not die | 8 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 non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Baricitinib | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 5 Days |
| Remdesivir Plus Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 4.5 Days |
| Remdesivir Plus Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 4 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 Baricitinib | Duration of New Oxygen Use | Including imputations for participants who died | 3 Days |
| Remdesivir Plus Baricitinib | 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 Baricitinib | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 16 Days |
| Remdesivir Plus Baricitinib | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 13 Days |
| Remdesivir Plus Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 27 Days |
| Remdesivir Plus Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 20 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 Baricitinib | Duration of Oxygen Use | Among participants who did not die | 9 Days |
| Remdesivir Plus Baricitinib | Duration of Oxygen Use | Including imputations for participants who died | 10 Days |
| Remdesivir Plus Placebo | Duration of Oxygen Use | Including imputations for participants who died | 12 Days |
| Remdesivir Plus Placebo | Duration of Oxygen Use | Among participants who did not die | 10 Days |
Secondary
Mean Change 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: 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. 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) | Dispersion |
|---|---|---|---|---|
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 8 | -0.3 units on a scale | Standard Deviation 0.9 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 15 | -2.3 units on a scale | Standard Deviation 1.9 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 5 | 0.0 units on a scale | Standard Deviation 0.7 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 22 | -2.7 units on a scale | Standard Deviation 1.9 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 11 | -0.4 units on a scale | Standard Deviation 1 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 29 | -2.9 units on a scale | Standard Deviation 1.9 |
| Remdesivir Plus Baricitinib | Mean Change in the Ordinal Scale | Day 3 | 0.1 units on a scale | Standard Deviation 0.5 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 29 | -2.5 units on a scale | Standard Deviation 2.1 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 3 | 0.1 units on a scale | Standard Deviation 0.6 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 5 | 0.0 units on a scale | Standard Deviation 0.7 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 8 | -0.1 units on a scale | Standard Deviation 0.9 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 11 | -0.2 units on a scale | Standard Deviation 1 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 15 | -1.9 units on a scale | Standard Deviation 2 |
| Remdesivir Plus Placebo | Mean Change in the Ordinal Scale | Day 22 | -2.3 units on a scale | Standard Deviation 2.1 |
Secondary
Percentage of Participants at Each Clinical Status Using 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 Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 56 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 20 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 14 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 10 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discharged | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discontinued | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Death at or before study Visit | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discontinued | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Death at or before study Visit | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 11 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 22 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 53 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 14 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, not requiring O2, no longer req care | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discharged | 0 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 12 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 9 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 11 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discharged | 56 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discontinued | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discontinued | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Death at or before study Visit | 2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 16 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on non-invasive vent./high flow O2 | 7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 10 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Hospitalized | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discharged | 52 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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. 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 intent-to-treat (ITT) population includes all participants who were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Death at or before study visit | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 9 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 8 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 34 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 34 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 32 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Death at or before study visit | 3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 16 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 31 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on non-invasive vent./high flow O2 | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 10 percentage of participants |
p-value: 0.4495% CI: [1.01, 1.57]Regression, Logistic
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 24 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 44 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discharged | 4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discontinued | 9 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Death at or before study Visit | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discontinued | 10 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Death at or before study Visit | 6 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 9 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 5 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not requiring O2, no longer req care | 0.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 25 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 37 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discharged | 3 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Death at or before study Visit | 5 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 23 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 49 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discharged | 0.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discontinued | 12 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status, completed study without reporting score | 0.2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discontinued | 13 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Death at or before study Visit | 7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 23 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 7 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discharged | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on non-invasive vent./high flow O2 | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 43 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status, completed study without reporting score | 0.2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, not requiring O2, no longer req care | 0.2 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 45 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 22 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 16 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 15 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discharged | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discontinued | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Death at or before study Visit | 0.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Death at or before study Visit | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 16 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 22 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 44 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 14 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discharged | 0.4 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 35 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 17 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 19 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 15 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discharged | 10 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discontinued | 3 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Death at or before study Visit | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 18 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 18 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 33 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 15 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Hospitalized | 0.2 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discharged | 13 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 18 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 11 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 12 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 13 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discharged | 40 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discontinued | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discontinued | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 18 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 12 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 18 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 10 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, not requiring O2, no longer req care | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, limit on activities/req home O2 | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Hospitalized | 0.4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discharged | 36 percentage of participants |
Secondary
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
Time frame: Day 1 through Day 14
Population: The intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 10 Infusions of Remdesivir due to Discharge | 55 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 10 Infusions of Remdesivir due to Death | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 14 doses of Baricitinib/Placebo due to Discharge | 66 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 14 doses of Baricitinib/Placebo due to Death | 0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Had Any Infusions of Remdesivir Halted or Slowed | 2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Had Any Oral Doses of Baricitinib/Placebo Modified | 16 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed Any Maintenance Dose of Remdesivir | 23 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed Any Oral Dose of Baricitinib/Placebo | 30 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Terminated Early Prior to Completing 10 Infusions of Remdesivir | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed Any Oral Dose of Baricitinib/Placebo | 34 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 10 Infusions of Remdesivir due to Discharge | 51 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Had Any Oral Doses of Baricitinib/Placebo Modified | 18 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 10 Infusions of Remdesivir due to Death | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo | 5 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 14 doses of Baricitinib/Placebo due to Discharge | 59 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed Any Maintenance Dose of Remdesivir | 27 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Received less than 14 doses of Baricitinib/Placebo due to Death | 1 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Terminated Early Prior to Completing 10 Infusions of Remdesivir | 4 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Had Any Infusions of Remdesivir Halted or Slowed | 2 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 Baricitinib | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 40.8 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 46.8 percentage of participants |
95% CI: [-12, 0]
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 Baricitinib | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 16.0 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 21.0 percentage of participants |
95% CI: [-10, 0]
Secondary
Percentage of Participants Requiring New Oxygen Use
The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants not requiring oxygen at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Requiring New Oxygen Use | 23 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Requiring New Oxygen Use | 40 percentage of participants |
Secondary
Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 10 percentage of participants |
| Remdesivir Plus Placebo | Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 15 percentage 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 ITT population includes all participants as randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to an Improvement of One Category Using an Ordinal Scale | 6.0 Days |
| Remdesivir Plus Placebo | Time to an Improvement of One Category Using an Ordinal Scale | 8.0 Days |
p-value: 0.00295% CI: [1.06, 1.39]Log Rank
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 ITT population includes all participants as randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to an Improvement of Two Categories Using an Ordinal Scale | 12.0 Days |
| Remdesivir Plus Placebo | Time to an Improvement of Two Categories Using an Ordinal Scale | 13.0 Days |
p-value: 0.00595% CI: [1.05, 1.38]Log Rank
Secondary
Time to Discharge or to a NEWS of 2 or Less 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 ITT population includes participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First | 6.0 Days |
| Remdesivir Plus Placebo | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First | 7.0 Days |
p-value: 0.00395% CI: [1.07, 1.44]Log Rank