COVID-19
Conditions
Keywords
Adaptive, COVID-19, Efficacy, Multicenter, novel coronavirus, Safety, ACTT
Brief summary
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. There will be interim monitoring to introduce new arms and 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. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.
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. There will be interim monitoring to introduce new arms and 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. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. The initial sample size is projected to be 572 subjects to achieve 400 subjects with a recovered status (per the primary objective). The primary analysis will be based on those subjects enrolled in order to 400 recoveries. An additional analysis of the moderate severity subgroup (those with baseline status of Hospitalized, requiring supplemental oxygen or Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care) is also of public health importance. Hence, enrollment will be permitted until the date of April 20, 2020 to ensure 400 recoveries and provide additional data about this important subgroup. With recent enrollment rates, the total sample size may be 600 to over 800. 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 as an outpatient. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and 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, Day 15 and 29 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 may also be 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. As little is known about the clinical course of COVID-19, a pilot study will be used for a blinded sample size reassessment. Contacts: 20-0006 Central Contact Telephone: 1 (301) 7617948 Email: DMIDClinicalTrials@niaid.nih.gov
Interventions
OTHERPlacebo
The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.
DRUGRemdesivir
Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Admitted to a hospital with symptoms suggestive of COVID-19 infection. 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 or the following: 1. PCR positive in sample collected \< 72 hours prior to randomization; OR
Exclusion criteria
2. 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: 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR 2. SpO2 \< / = 94% on room air, OR 3. Requiring supplemental oxygen, OR 4. Requiring mechanical ventilation. 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 or SARS-CoV-2 through Day 29.
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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. |
| 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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. |
| 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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. |
| 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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. |
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 Time (PT) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate PT 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 | Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| 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 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 15 | Day 15 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Percentage of Participants 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. |
| 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. |
| Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Day 1 through Day 10 | 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. |
| 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 |
| Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use | Day 1 through Day 29 | New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen 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 |
| 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 |
| 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. |
| 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. |
| 29-day Participant Mortality | Day 1 through Day 29 | The mortality rate was determined as the proportion of participants who died by study Day 29. |
| Time to an Improvement by at Least 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 |
| 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. |
| 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. |
| Time to an Improvement of at Least 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 |
| 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 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 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, Germany, Greece, 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 21FEB2020 and 20APR2020.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. | 521 |
| Remdesivir 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 days total course. | 541 |
| Total | 1,062 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Enrolled but not treated | 4 | 10 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Transferred to another hospital | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Placebo | Remdesivir | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 197 Participants | 187 Participants | 384 Participants |
| Age, Categorical Between 18 and 65 years | 324 Participants | 354 Participants | 678 Participants |
| Age, Continuous | 59.2 years STANDARD_DEVIATION 15.4 | 58.6 years STANDARD_DEVIATION 14.6 | 58.9 years STANDARD_DEVIATION 15 |
| Disease severity Mild-to-moderate disease severity | 50 Participants | 55 Participants | 105 Participants |
| Disease severity Severe disease severity | 471 Participants | 486 Participants | 957 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 116 Participants | 134 Participants | 250 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 373 Participants | 382 Participants | 755 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants | 25 Participants | 57 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 56 Participants | 79 Participants | 135 Participants |
| Race (NIH/OMB) Black or African American | 117 Participants | 109 Participants | 226 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 55 Participants | 66 Participants | 121 Participants |
| Race (NIH/OMB) White | 287 Participants | 279 Participants | 566 Participants |
| Region of Enrollment Denmark | 21 participants | 22 participants | 43 participants |
| Region of Enrollment Germany | 6 participants | 7 participants | 13 participants |
| Region of Enrollment Greece | 19 participants | 14 participants | 33 participants |
| Region of Enrollment Japan | 7 participants | 8 participants | 15 participants |
| Region of Enrollment Mexico | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Singapore | 7 participants | 9 participants | 16 participants |
| Region of Enrollment South Korea | 12 participants | 9 participants | 21 participants |
| Region of Enrollment Spain | 12 participants | 16 participants | 28 participants |
| Region of Enrollment United Kingdom | 21 participants | 25 participants | 46 participants |
| Region of Enrollment United States | 410 participants | 427 participants | 837 participants |
| Sex: Female, Male Female | 189 Participants | 189 Participants | 378 Participants |
| Sex: Female, Male Male | 332 Participants | 352 Participants | 684 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 77 / 521 | 59 / 541 |
| other Total, other adverse events | 295 / 516 | 276 / 532 |
| serious Total, serious adverse events | 163 / 516 | 131 / 532 |
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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time frame: Day 1 through Day 29
Population: The intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Recovery | 15 Days |
| Remdesivir | Time to Recovery | 10 Days |
p-value: <0.00195% CI: [1.12, 1.49]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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
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) |
|---|---|---|---|
| Placebo | Time to Recovery by Ethnicity | Not Hispanic or Latino | 15.0 Days |
| Placebo | Time to Recovery by Ethnicity | Hispanic or Latino | 12.5 Days |
| Remdesivir | Time to Recovery by Ethnicity | Not Hispanic or Latino | 10.0 Days |
| Remdesivir | Time to Recovery by Ethnicity | Hispanic or Latino | 10.0 Days |
Comparison: This analysis is for Not Hispanic or Latino participants95% CI: [1.1, 1.55]
Comparison: This analysis is for Hispanic or Latino participants95% CI: [0.94, 1.73]
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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
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) |
|---|---|---|---|
| Placebo | Time to Recovery by Race | Black or African American | 15.0 Days |
| Placebo | Time to Recovery by Race | Asian | 12.0 Days |
| Placebo | Time to Recovery by Race | White | 15.0 Days |
| Placebo | Time to Recovery by Race | Other | 24.0 Days |
| Remdesivir | Time to Recovery by Race | Black or African American | 10.0 Days |
| Remdesivir | Time to Recovery by Race | Other | 9.0 Days |
| Remdesivir | Time to Recovery by Race | White | 9.0 Days |
| Remdesivir | Time to Recovery by Race | Asian | 11.0 Days |
Comparison: This analysis is for Asian participants95% CI: [0.73, 1.58]
Comparison: This analysis is for Black or African American participants95% CI: [0.91, 1.72]
Comparison: This analysis is for White participants95% CI: [1.06, 1.57]
Comparison: This analysis is for Race of Other participants95% CI: [1.1, 2.58]
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) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
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) |
|---|---|---|---|
| Placebo | Time to Recovery by Sex | Male | 15.0 Days |
| Placebo | Time to Recovery by Sex | Female | 15.0 Days |
| Remdesivir | Time to Recovery by Sex | Male | 9.0 Days |
| Remdesivir | Time to Recovery by Sex | Female | 10.0 Days |
Comparison: This analysis is for Male participants95% CI: [1.09, 1.56]
Comparison: This analysis is for Female participants95% CI: [1.03, 1.66]
Secondary
14-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 15.
Time frame: Day 1 through Day 15
Population: The ITT population consists of all participants as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 14-day Participant Mortality | 0.12 Proportion of participants |
| Remdesivir | 14-day Participant Mortality | 0.07 Proportion of participants |
Secondary
29-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 29.
Time frame: Day 1 through Day 29
Population: The ITT population includes all participants as randomized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 29-day Participant Mortality | 0.15 Proportion of participants |
| Remdesivir | 29-day Participant Mortality | 0.11 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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 3 | 14.3 Units/Liter (U/L) | Standard Deviation 88 |
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 8 | 24.2 Units/Liter (U/L) | Standard Deviation 79.7 |
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 15 | 28.1 Units/Liter (U/L) | Standard Deviation 110.1 |
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 11 | 27.7 Units/Liter (U/L) | Standard Deviation 89.8 |
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 29 | -3.9 Units/Liter (U/L) | Standard Deviation 62.2 |
| Placebo | Change From Baseline in Alanine Transaminase (ALT) | Day 5 | 23.1 Units/Liter (U/L) | Standard Deviation 70.6 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 29 | -6.8 Units/Liter (U/L) | Standard Deviation 43.7 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 15 | 1.7 Units/Liter (U/L) | Standard Deviation 47.4 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 3 | 2.9 Units/Liter (U/L) | Standard Deviation 31.5 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 5 | 10.8 Units/Liter (U/L) | Standard Deviation 55.8 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 8 | 8.9 Units/Liter (U/L) | Standard Deviation 54.2 |
| Remdesivir | Change From Baseline in Alanine Transaminase (ALT) | Day 11 | 3.4 Units/Liter (U/L) | Standard Deviation 48.4 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 5 | 12.8 Units/Liter (U/L) | Standard Deviation 66.2 |
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 15 | 4.2 Units/Liter (U/L) | Standard Deviation 73 |
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 8 | 13.1 Units/Liter (U/L) | Standard Deviation 114.6 |
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 3 | 13.7 Units/Liter (U/L) | Standard Deviation 90.7 |
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 29 | -18.4 Units/Liter (U/L) | Standard Deviation 47.2 |
| Placebo | Change From Baseline in Aspartate Transaminase (AST) | Day 11 | 11.5 Units/Liter (U/L) | Standard Deviation 78.8 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 29 | -14.0 Units/Liter (U/L) | Standard Deviation 52.2 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 11 | -0.3 Units/Liter (U/L) | Standard Deviation 51.7 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 3 | -2.0 Units/Liter (U/L) | Standard Deviation 29.1 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 5 | 6.0 Units/Liter (U/L) | Standard Deviation 58.9 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 15 | -2.3 Units/Liter (U/L) | Standard Deviation 60.4 |
| Remdesivir | Change From Baseline in Aspartate Transaminase (AST) | Day 8 | 1.1 Units/Liter (U/L) | Standard Deviation 55.9 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Basophils | Day 5 | 0.038 10^9 cells/liter | Standard Deviation 0.501 |
| Placebo | Change From Baseline in Basophils | Day 8 | 0.196 10^9 cells/liter | Standard Deviation 3.132 |
| Placebo | Change From Baseline in Basophils | Day 11 | 0.024 10^9 cells/liter | Standard Deviation 0.042 |
| Placebo | Change From Baseline in Basophils | Day 3 | 0.020 10^9 cells/liter | Standard Deviation 0.257 |
| Placebo | Change From Baseline in Basophils | Day 15 | 0.158 10^9 cells/liter | Standard Deviation 1.913 |
| Placebo | Change From Baseline in Basophils | Day 29 | 0.040 10^9 cells/liter | Standard Deviation 0.073 |
| Remdesivir | Change From Baseline in Basophils | Day 15 | -0.058 10^9 cells/liter | Standard Deviation 1.028 |
| Remdesivir | Change From Baseline in Basophils | Day 5 | 0.005 10^9 cells/liter | Standard Deviation 0.37 |
| Remdesivir | Change From Baseline in Basophils | Day 3 | 0.005 10^9 cells/liter | Standard Deviation 0.043 |
| Remdesivir | Change From Baseline in Basophils | Day 8 | 0.005 10^9 cells/liter | Standard Deviation 0.368 |
| Remdesivir | Change From Baseline in Basophils | Day 29 | 0.029 10^9 cells/liter | Standard Deviation 0.054 |
| Remdesivir | Change From Baseline in Basophils | Day 11 | 0.028 10^9 cells/liter | Standard Deviation 0.053 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Creatinine | Day 11 | 1.173 milligrams/deciliter (mg/dL) | Standard Deviation 15.44 |
| Placebo | Change From Baseline in Creatinine | Day 29 | -1.863 milligrams/deciliter (mg/dL) | Standard Deviation 26.093 |
| Placebo | Change From Baseline in Creatinine | Day 8 | -0.882 milligrams/deciliter (mg/dL) | Standard Deviation 19.637 |
| Placebo | Change From Baseline in Creatinine | Day 3 | 0.037 milligrams/deciliter (mg/dL) | Standard Deviation 0.517 |
| Placebo | Change From Baseline in Creatinine | Day 15 | -1.239 milligrams/deciliter (mg/dL) | Standard Deviation 22.755 |
| Placebo | Change From Baseline in Creatinine | Day 5 | -0.695 milligrams/deciliter (mg/dL) | Standard Deviation 17.552 |
| Remdesivir | Change From Baseline in Creatinine | Day 15 | 0.319 milligrams/deciliter (mg/dL) | Standard Deviation 2.147 |
| Remdesivir | Change From Baseline in Creatinine | Day 8 | 0.158 milligrams/deciliter (mg/dL) | Standard Deviation 0.951 |
| Remdesivir | Change From Baseline in Creatinine | Day 11 | 0.236 milligrams/deciliter (mg/dL) | Standard Deviation 1.057 |
| Remdesivir | Change From Baseline in Creatinine | Day 5 | 0.075 milligrams/deciliter (mg/dL) | Standard Deviation 0.762 |
| Remdesivir | Change From Baseline in Creatinine | Day 29 | 0.075 milligrams/deciliter (mg/dL) | Standard Deviation 0.644 |
| Remdesivir | Change From Baseline in Creatinine | Day 3 | 0.038 milligrams/deciliter (mg/dL) | Standard Deviation 0.569 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Eosinophils | Day 3 | 0.634 10^9 cells/liter | Standard Deviation 10.614 |
| Placebo | Change From Baseline in Eosinophils | Day 5 | 0.666 10^9 cells/liter | Standard Deviation 11.977 |
| Placebo | Change From Baseline in Eosinophils | Day 8 | 0.596 10^9 cells/liter | Standard Deviation 8.875 |
| Placebo | Change From Baseline in Eosinophils | Day 11 | 0.093 10^9 cells/liter | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Eosinophils | Day 15 | 1.992 10^9 cells/liter | Standard Deviation 20.365 |
| Placebo | Change From Baseline in Eosinophils | Day 29 | 0.241 10^9 cells/liter | Standard Deviation 0.324 |
| Remdesivir | Change From Baseline in Eosinophils | Day 15 | -0.420 10^9 cells/liter | Standard Deviation 5.378 |
| Remdesivir | Change From Baseline in Eosinophils | Day 3 | 0.016 10^9 cells/liter | Standard Deviation 0.727 |
| Remdesivir | Change From Baseline in Eosinophils | Day 11 | -0.088 10^9 cells/liter | Standard Deviation 2.973 |
| Remdesivir | Change From Baseline in Eosinophils | Day 5 | -0.066 10^9 cells/liter | Standard Deviation 2.807 |
| Remdesivir | Change From Baseline in Eosinophils | Day 29 | 0.211 10^9 cells/liter | Standard Deviation 0.267 |
| Remdesivir | Change From Baseline in Eosinophils | Day 8 | -0.221 10^9 cells/liter | Standard Deviation 4.108 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glucose | Day 3 | -0.2 mg/dL | Standard Deviation 53.4 |
| Placebo | Change From Baseline in Glucose | Day 5 | 6.3 mg/dL | Standard Deviation 60.2 |
| Placebo | Change From Baseline in Glucose | Day 8 | 2.2 mg/dL | Standard Deviation 73.3 |
| Placebo | Change From Baseline in Glucose | Day 11 | 1.0 mg/dL | Standard Deviation 70.1 |
| Placebo | Change From Baseline in Glucose | Day 15 | -2.8 mg/dL | Standard Deviation 64.4 |
| Placebo | Change From Baseline in Glucose | Day 29 | -13.5 mg/dL | Standard Deviation 96.8 |
| Remdesivir | Change From Baseline in Glucose | Day 15 | -2.9 mg/dL | Standard Deviation 75.4 |
| Remdesivir | Change From Baseline in Glucose | Day 3 | -3.0 mg/dL | Standard Deviation 49.4 |
| Remdesivir | Change From Baseline in Glucose | Day 11 | -0.1 mg/dL | Standard Deviation 77.4 |
| Remdesivir | Change From Baseline in Glucose | Day 5 | 2.1 mg/dL | Standard Deviation 63.8 |
| Remdesivir | Change From Baseline in Glucose | Day 29 | -11.7 mg/dL | Standard Deviation 75.4 |
| Remdesivir | Change From Baseline in Glucose | Day 8 | 3.2 mg/dL | Standard Deviation 68 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin | Day 8 | -1.22 grams/deciliter (g/dL) | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Hemoglobin | Day 3 | -0.52 grams/deciliter (g/dL) | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Hemoglobin | Day 15 | -1.51 grams/deciliter (g/dL) | Standard Deviation 2.02 |
| Placebo | Change From Baseline in Hemoglobin | Day 5 | -0.83 grams/deciliter (g/dL) | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Hemoglobin | Day 29 | -1.02 grams/deciliter (g/dL) | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Hemoglobin | Day 11 | -1.66 grams/deciliter (g/dL) | Standard Deviation 1.67 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 29 | -1.21 grams/deciliter (g/dL) | Standard Deviation 7.91 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 3 | -0.69 grams/deciliter (g/dL) | Standard Deviation 5.36 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 5 | -0.99 grams/deciliter (g/dL) | Standard Deviation 5.83 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 11 | -1.29 grams/deciliter (g/dL) | Standard Deviation 1.93 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 15 | -1.02 grams/deciliter (g/dL) | Standard Deviation 3.04 |
| Remdesivir | Change From Baseline in Hemoglobin | Day 8 | -0.49 grams/deciliter (g/dL) | Standard Deviation 6.54 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lymphocytes | Day 3 | 5.883 10^9 cells/liter | Standard Deviation 118.74 |
| Placebo | Change From Baseline in Lymphocytes | Day 5 | 4.064 10^9 cells/liter | Standard Deviation 141.58 |
| Placebo | Change From Baseline in Lymphocytes | Day 8 | 8.006 10^9 cells/liter | Standard Deviation 137.149 |
| Placebo | Change From Baseline in Lymphocytes | Day 11 | 0.393 10^9 cells/liter | Standard Deviation 1.371 |
| Placebo | Change From Baseline in Lymphocytes | Day 15 | 14.793 10^9 cells/liter | Standard Deviation 159.583 |
| Placebo | Change From Baseline in Lymphocytes | Day 29 | 0.668 10^9 cells/liter | Standard Deviation 1.406 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 15 | -23.836 10^9 cells/liter | Standard Deviation 218.653 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 3 | -7.847 10^9 cells/liter | Standard Deviation 131.548 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 11 | -12.016 10^9 cells/liter | Standard Deviation 183.06 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 5 | -11.723 10^9 cells/liter | Standard Deviation 167.428 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 29 | 0.743 10^9 cells/liter | Standard Deviation 0.664 |
| Remdesivir | Change From Baseline in Lymphocytes | Day 8 | -15.455 10^9 cells/liter | Standard Deviation 194.111 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Monocytes | Day 3 | 2.448 10^9 cells/liter | Standard Deviation 41.304 |
| Placebo | Change From Baseline in Monocytes | Day 8 | 2.324 10^9 cells/liter | Standard Deviation 36.626 |
| Placebo | Change From Baseline in Monocytes | Day 15 | 6.475 10^9 cells/liter | Standard Deviation 69.019 |
| Placebo | Change From Baseline in Monocytes | Day 5 | 1.498 10^9 cells/liter | Standard Deviation 57.686 |
| Placebo | Change From Baseline in Monocytes | Day 29 | 0.125 10^9 cells/liter | Standard Deviation 0.485 |
| Placebo | Change From Baseline in Monocytes | Day 11 | 0.383 10^9 cells/liter | Standard Deviation 0.744 |
| Remdesivir | Change From Baseline in Monocytes | Day 29 | 0.117 10^9 cells/liter | Standard Deviation 0.34 |
| Remdesivir | Change From Baseline in Monocytes | Day 11 | -2.539 10^9 cells/liter | Standard Deviation 43.454 |
| Remdesivir | Change From Baseline in Monocytes | Day 3 | -2.940 10^9 cells/liter | Standard Deviation 46.752 |
| Remdesivir | Change From Baseline in Monocytes | Day 5 | -2.628 10^9 cells/liter | Standard Deviation 39.329 |
| Remdesivir | Change From Baseline in Monocytes | Day 8 | -3.645 10^9 cells/liter | Standard Deviation 48.636 |
| Remdesivir | Change From Baseline in Monocytes | Day 15 | -8.738 10^9 cells/liter | Standard Deviation 74.365 |
Secondary
Change From Baseline in Neutrophils
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Neutrophils | Day 5 | 4.177 10^9 cells/liter | Standard Deviation 362.782 |
| Placebo | Change From Baseline in Neutrophils | Day 8 | 17.916 10^9 cells/liter | Standard Deviation 305.321 |
| Placebo | Change From Baseline in Neutrophils | Day 11 | 3.010 10^9 cells/liter | Standard Deviation 27.502 |
| Placebo | Change From Baseline in Neutrophils | Day 29 | -1.269 10^9 cells/liter | Standard Deviation 7.16 |
| Placebo | Change From Baseline in Neutrophils | Day 15 | 36.024 10^9 cells/liter | Standard Deviation 389.093 |
| Placebo | Change From Baseline in Neutrophils | Day 3 | 9.429 10^9 cells/liter | Standard Deviation 260.345 |
| Remdesivir | Change From Baseline in Neutrophils | Day 15 | -39.988 10^9 cells/liter | Standard Deviation 333.088 |
| Remdesivir | Change From Baseline in Neutrophils | Day 3 | -8.093 10^9 cells/liter | Standard Deviation 135.068 |
| Remdesivir | Change From Baseline in Neutrophils | Day 5 | -15.067 10^9 cells/liter | Standard Deviation 216.532 |
| Remdesivir | Change From Baseline in Neutrophils | Day 29 | -0.840 10^9 cells/liter | Standard Deviation 3.666 |
| Remdesivir | Change From Baseline in Neutrophils | Day 8 | -28.179 10^9 cells/liter | Standard Deviation 365.099 |
| Remdesivir | Change From Baseline in Neutrophils | Day 11 | -21.773 10^9 cells/liter | Standard Deviation 354.025 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Platelets | Day 3 | 39.3 10^9 cells/liter | Standard Deviation 60 |
| Placebo | Change From Baseline in Platelets | Day 8 | 111.8 10^9 cells/liter | Standard Deviation 137.4 |
| Placebo | Change From Baseline in Platelets | Day 15 | 96.5 10^9 cells/liter | Standard Deviation 154.2 |
| Placebo | Change From Baseline in Platelets | Day 11 | 109.3 10^9 cells/liter | Standard Deviation 149.3 |
| Placebo | Change From Baseline in Platelets | Day 29 | 32.7 10^9 cells/liter | Standard Deviation 124.2 |
| Placebo | Change From Baseline in Platelets | Day 5 | 76.5 10^9 cells/liter | Standard Deviation 100.5 |
| Remdesivir | Change From Baseline in Platelets | Day 29 | 39.6 10^9 cells/liter | Standard Deviation 107.4 |
| Remdesivir | Change From Baseline in Platelets | Day 15 | 71.1 10^9 cells/liter | Standard Deviation 133.3 |
| Remdesivir | Change From Baseline in Platelets | Day 3 | 46.0 10^9 cells/liter | Standard Deviation 62.6 |
| Remdesivir | Change From Baseline in Platelets | Day 5 | 90.1 10^9 cells/liter | Standard Deviation 99.9 |
| Remdesivir | Change From Baseline in Platelets | Day 8 | 130.8 10^9 cells/liter | Standard Deviation 128.1 |
| Remdesivir | Change From Baseline in Platelets | Day 11 | 101.0 10^9 cells/liter | Standard Deviation 145 |
Secondary
Change From Baseline in Prothrombin Time (PT)
Blood to evaluate PT 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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 15 | 0.34 seconds | Standard Deviation 4.33 |
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 5 | -0.30 seconds | Standard Deviation 4.72 |
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 11 | 0.86 seconds | Standard Deviation 7.85 |
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 8 | 0.01 seconds | Standard Deviation 2.59 |
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 29 | -0.28 seconds | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Prothrombin Time (PT) | Day 3 | -0.18 seconds | Standard Deviation 4.28 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 29 | -0.63 seconds | Standard Deviation 3.37 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 11 | 1.88 seconds | Standard Deviation 5.68 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 15 | -0.03 seconds | Standard Deviation 4.25 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 3 | 0.44 seconds | Standard Deviation 5.22 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 5 | 1.15 seconds | Standard Deviation 5.72 |
| Remdesivir | Change From Baseline in Prothrombin Time (PT) | Day 8 | 1.43 seconds | Standard Deviation 3.89 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Bilirubin | Day 11 | 0.23 mg/dL | Standard Deviation 2.79 |
| Placebo | Change From Baseline in Total Bilirubin | Day 3 | 0.08 mg/dL | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Total Bilirubin | Day 15 | 0.00 mg/dL | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Total Bilirubin | Day 8 | 0.22 mg/dL | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Total Bilirubin | Day 29 | -0.17 mg/dL | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Total Bilirubin | Day 5 | 0.58 mg/dL | Standard Deviation 4.13 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 29 | -0.12 mg/dL | Standard Deviation 1.77 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 5 | -0.03 mg/dL | Standard Deviation 1.03 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 8 | 0.01 mg/dL | Standard Deviation 1.38 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 11 | 0.07 mg/dL | Standard Deviation 1.48 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 15 | 0.09 mg/dL | Standard Deviation 1.54 |
| Remdesivir | Change From Baseline in Total Bilirubin | Day 3 | -0.04 mg/dL | Standard Deviation 0.75 |
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 |
|---|---|---|---|---|
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 18.691 10^9 cells/liter | Standard Deviation 424.837 |
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 9.886 10^9 cells/liter | Standard Deviation 566.175 |
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 27.223 10^9 cells/liter | Standard Deviation 479.095 |
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 1.967 10^9 cells/liter | Standard Deviation 16.042 |
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 56.311 10^9 cells/liter | Standard Deviation 620.551 |
| Placebo | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | -0.898 10^9 cells/liter | Standard Deviation 17.801 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | -70.884 10^9 cells/liter | Standard Deviation 600.011 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | -18.970 10^9 cells/liter | Standard Deviation 301.944 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | -34.702 10^9 cells/liter | Standard Deviation 574.065 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | -28.209 10^9 cells/liter | Standard Deviation 412.615 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | 0.251 10^9 cells/liter | Standard Deviation 3.987 |
| Remdesivir | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | -45.997 10^9 cells/liter | Standard Deviation 602.461 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | 0.1 units on a scale | Standard Deviation 2.8 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | 0.3 units on a scale | Standard Deviation 3.3 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -0.3 units on a scale | Standard Deviation 3.8 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -0.3 units on a scale | Standard Deviation 4.1 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.4 units on a scale | Standard Deviation 4.2 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.4 units on a scale | Standard Deviation 4 |
| Placebo | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -3.2 units on a scale | Standard Deviation 4 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 29 | -3.3 units on a scale | Standard Deviation 3.2 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 3 | -0.3 units on a scale | Standard Deviation 2.6 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 11 | -0.5 units on a scale | Standard Deviation 3.5 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 15 | -1.7 units on a scale | Standard Deviation 3.6 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 5 | -0.4 units on a scale | Standard Deviation 2.9 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 22 | -1.7 units on a scale | Standard Deviation 4.1 |
| Remdesivir | Change in National Early Warning Score (NEWS) From Baseline | Day 8 | -0.5 units on a scale | Standard Deviation 3.2 |
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) |
|---|---|---|---|
| Placebo | Duration of Hospitalization | Including imputation for participants who died | 17 Days |
| Placebo | Duration of Hospitalization | Restricted to participants who did not die | 14 Days |
| Remdesivir | Duration of Hospitalization | Including imputation for participants who died | 12 Days |
| Remdesivir | Duration of Hospitalization | Restricted to participants who did not die | 10 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) |
|---|---|---|---|
| Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 4 Days |
| Placebo | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 3 Days |
| Remdesivir | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Including imputations for participants who died | 3 Days |
| Remdesivir | Duration of New Non-invasive Ventilation or High Flow Oxygen Use | Among participants who did not die | 3 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) |
|---|---|---|---|
| Placebo | Duration of New Oxygen Use | Including imputations for participants who died | 5.5 Days |
| Placebo | Duration of New Oxygen Use | Among participants who did not die | 3 Days |
| Remdesivir | Duration of New Oxygen Use | Including imputations for participants who died | 4 Days |
| Remdesivir | Duration of New Oxygen Use | Among participants who did not die | 3.5 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) |
|---|---|---|---|
| Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 23 Days |
| Placebo | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 16 Days |
| Remdesivir | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Including imputations for participants who died | 21.5 Days |
| Remdesivir | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | Among participants who did not die | 14 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. Clinical scores of 8 were carried forward from the date of death for participants who died.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in the Ordinal Scale | Day 3 | 0.2 units on a scale | Standard Deviation 0.6 |
| Placebo | Mean Change in the Ordinal Scale | Day 8 | 0.0 units on a scale | Standard Deviation 0.1 |
| Placebo | Mean Change in the Ordinal Scale | Day 11 | -0.1 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Change in the Ordinal Scale | Day 22 | -1.9 units on a scale | Standard Deviation 2.5 |
| Placebo | Mean Change in the Ordinal Scale | Day 15 | -1.4 units on a scale | Standard Deviation 2.3 |
| Placebo | Mean Change in the Ordinal Scale | Day 5 | 0.1 units on a scale | Standard Deviation 0.9 |
| Placebo | Mean Change in the Ordinal Scale | Day 29 | -2.3 units on a scale | Standard Deviation 2.6 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 5 | 0.0 units on a scale | Standard Deviation 0.8 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 15 | -1.9 units on a scale | Standard Deviation 2.1 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 29 | -2.7 units on a scale | Standard Deviation 2.3 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 3 | 0.1 units on a scale | Standard Deviation 0.6 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 8 | -0.2 units on a scale | Standard Deviation 1 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 11 | -0.3 units on a scale | Standard Deviation 1.1 |
| Remdesivir | Mean Change in the Ordinal Scale | Day 22 | -2.4 units on a scale | Standard Deviation 2.2 |
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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, not on O2, requiring ongoing care | 12 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Death at or before study Visit | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 30 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 19 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 39 percentage of participants |
| 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 |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discharged | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discontinued | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, requiring supplemental oxygen | 43 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Hospitalized | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discontinued | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | No clinical status score reported - Discharged | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Death at or before study Visit | 0 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on invasive mech. vent. or ECMO | 24 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Hospitalized, on non-invasive vent./high flow O2 | 18 percentage of participants |
| Remdesivir | 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 |
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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not on O2, requiring ongoing care | 6 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Death at or before study Visit | 8 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 0.4 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 28 percentage of participants |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discharged | 33 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 13 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discontinued | 4 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, requiring supplemental oxygen | 11 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Discharged | 44 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, on invasive mech. vent. or ECMO | 22 percentage of participants |
| Remdesivir | 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 | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Hospitalized, not requiring O2, no longer req care | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, limit on activities/req home O2 | 0.4 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Death at or before study Visit | 4 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.
Time frame: Day 15
Population: The intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Death at or before study Visit | 11 percentage of participants |
| Placebo | 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 |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 17 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Discharged | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 22 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 11 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 22 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Discontinued | 3 percentage of participants |
| Placebo | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Discontinued | 5 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Death at or before study Visit | 6 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, on invasive mech. vent. or ECMO | 15 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, requiring supplemental oxygen | 10 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not on O2, requiring ongoing care | 7 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Hospitalized, not requiring O2, no longer req care | 3 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, limit on activities/req home O2 | 19 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Not hospitalized, no limitations on activities | 29 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Discharged | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | No clinical status score reported - Hospitalized | 0 percentage of participants |
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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 32 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 18 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 8 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discharged | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on invasive mech. vent. or ECMO | 14 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discontinued | 4 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 5 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Completed study without reporting score | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Death at or before study Visit | 13 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Completed study without reporting score | 0.2 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Death at or before study Visit | 9 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, on non-invasive vent./high flow O2 | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, requiring supplemental oxygen | 5 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Hospitalized, not on O2, requiring ongoing care | 6 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, limit on activities/req home O2 | 19 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Not hospitalized, no limitations on activities | 39 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discharged | 3 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | No clinical status score reported - Discontinued | 6 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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 9 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 19 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Death at or before study Visit | 15 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 36 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, not on O2, requiring ongoing care | 3 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Hospitalized | 0.2 percentage of participants |
| Placebo | 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discharged | 3 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discontinued | 5 percentage of participants |
| Placebo | 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Completed study without reporting score | 3 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 4 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Completed study without reporting score | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discharged | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Death at or before study Visit | 11 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, on invasive mech. vent. or ECMO | 6 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Hospitalized, requiring supplemental oxygen | 4 percentage of participants |
| Remdesivir | 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 | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, limit on activities/req home O2 | 20 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Not hospitalized, no limitations on activities | 46 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | No clinical status score reported - Discontinued | 7 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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 36 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not requiring O2, no longer req care | 0.4 percentage of participants |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 17 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discontinued | 1 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 32 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discharged | 0.2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 12 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Death at or before study Visit | 1 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on invasive mech. vent. or ECMO | 28 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, on non-invasive vent./high flow O2 | 16 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, requiring supplemental oxygen | 37 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Hospitalized, not on O2, requiring ongoing care | 13 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Not hospitalized, no limitations on activities | 0.4 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | No clinical status score reported - Discharged | 2 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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 37 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Death at or before study Visit | 2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 14 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 26 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 11 percentage of participants |
| 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 |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discharged | 7 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discharged | 12 percentage of participants |
| Remdesivir | 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 | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Death at or before study Visit | 2 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on invasive mech. vent. or ECMO | 28 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, on non-invasive vent./high flow O2 | 12 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | No clinical status score reported - Discontinued | 3 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, requiring supplemental oxygen | 28 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Hospitalized, not on O2, requiring ongoing care | 15 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) |
|---|---|---|---|
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 15 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Death at or before study Visit | 7 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 33 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 9 percentage of participants |
| 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 |
| 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 |
| 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 |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Hospitalized | 0 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discharged | 22 percentage of participants |
| Placebo | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discontinued | 2 percentage of participants |
| Remdesivir | 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 | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discontinued | 4 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Death at or before study Visit | 3 percentage of participants |
| Remdesivir | 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 | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on invasive mech. vent. or ECMO | 24 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Not hospitalized, no limitations on activities | 0 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, on non-invasive vent./high flow O2 | 9 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, requiring supplemental oxygen | 17 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | No clinical status score reported - Discharged | 30 percentage of participants |
| Remdesivir | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Hospitalized, not on O2, requiring ongoing care | 11 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.
Time frame: Day 1 through Day 10
Population: The intent-to-treat (ITT) population includes all participants who were randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Discontinued due to discharge | 30 percentage of participants |
| Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Discontinued due to death | 4 percentage of participants |
| Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Any infusions halted or slowed | 2 percentage of participants |
| Placebo | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed any maintenance dose | 21 percentage of participants |
| Remdesivir | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Missed any maintenance dose | 16 percentage of participants |
| Remdesivir | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Discontinued due to discharge | 41 percentage of participants |
| Remdesivir | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Any infusions halted or slowed | 2 percentage of participants |
| Remdesivir | Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics | Discontinued due to death | 3 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) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 57 percentage of participants |
| Remdesivir | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 51 percentage of participants |
p-value: 0.058Barnard's Exact Test
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) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 32 percentage of participants |
| Remdesivir | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 24 percentage of participants |
p-value: 0.01Barnard's Exact Test
Secondary
Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use | 24 percentage of participants |
| Remdesivir | Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use | 17 percentage of participants |
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) |
|---|---|---|
| Placebo | Percentage of Participants Requiring New Oxygen Use | 44 percentage of participants |
| Remdesivir | Percentage of Participants Requiring New Oxygen Use | 36 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) |
|---|---|---|
| Placebo | Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 23 percentage of participants |
| Remdesivir | Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use | 13 percentage of participants |
Secondary
Time to an Improvement by at Least 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) |
|---|---|---|
| Placebo | Time to an Improvement by at Least One Category Using an Ordinal Scale | 9 Days |
| Remdesivir | Time to an Improvement by at Least One Category Using an Ordinal Scale | 7 Days |
p-value: 0.00295% CI: [1.08, 1.41]Log Rank
Secondary
Time to an Improvement of at Least 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) |
|---|---|---|
| Placebo | Time to an Improvement of at Least Two Categories Using an Ordinal Scale | 14 Days |
| Remdesivir | Time to an Improvement of at Least Two Categories Using an Ordinal Scale | 11 Days |
p-value: <0.00195% CI: [1.12, 1.48]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 all participants as randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First | 12 Days |
| Remdesivir | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First | 8 Days |
p-value: <0.00195% CI: [1.1, 1.46]Log Rank