COVID-19
Conditions
Brief summary
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
Interventions
DRUGRemdesivir
Administered as Intravenous (IV) infusion once daily
DRUGRDV Placebo
Administered as IV saline once daily
DRUGStandard of Care
Standard of Care Treatment for COVID-19 Infection
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen * Hospitalized for COVID-19 * Weighing at least 40 kilograms (kg) * Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19 * Have either: * a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis * b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care * The interval between COVID-19 symptoms onset and randomization is no more than 10 days Key
Exclusion criteria
* Received any investigational drug, RDV, or other antiviral treatment for COVID-19 * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal * Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI) * Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding * Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD) Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29 | First dose date up to Day 29 | This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Initiation of IMV Through Day 29 | First dose date up to Day 29 | The reported percentage was the cumulative-incidence estimate. |
| Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29 | First dose date up to Day 29 | Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported. |
| Time to Recovery Independent of Further Worsening by Day 29 | First dose date up to Day 29 | Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported. |
| Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Day 15 | Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status. |
| Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Day 29 | Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status. |
| All-cause Mortality Through Day 29 | First dose date up to Day 29 | The reported percentage was from the Kaplan-Meier estimate. |
| Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29 | First dose date up to Day 29 | Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death. |
| Percentage of Participants With Recovery Independent of Further Worsening Through Day 29 | First dose date up to Day 29 | Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death. |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) | First dose date up to last dose date (Maximum: 5 days) plus 30 days | An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs. |
| Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs) | First dose date up to last dose date (Maximum: 5 days) | An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug. |
| Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29 | First dose date up to Day 29 | The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT. |
Countries
Brazil, Portugal, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.
Pre-assignment details
258 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Remdesivir (RDV) Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5. | 163 |
| Placebo Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5. | 80 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Death | 51 | 25 |
| Overall Study | Investigator's Discretion | 2 | 0 |
| Overall Study | Lost to Follow-up | 9 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Randomized but Never Treated | 3 | 3 |
| Overall Study | Withdrew Consent | 1 | 2 |
Baseline characteristics
| Characteristic | Remdesivir (RDV) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 14.1 | 71 years STANDARD_DEVIATION 13 | 69 years STANDARD_DEVIATION 13.8 |
| Age, Customized Age Categorical >= 18 to < 65 Years | 70 Participants | 22 Participants | 92 Participants |
| Age, Customized Age Categorical < 18 Years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age Categorical >= 65 Years | 93 Participants | 58 Participants | 151 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 1 | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 2 | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 3 | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 4 | 36 Participants | 18 Participants | 54 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 5 | 97 Participants | 47 Participants | 144 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 6 | 30 Participants | 15 Participants | 45 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 7 | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status (8-point Ordinal Scale) Score: 8 | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 8 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 72 Participants | 207 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Black | 43 Participants | 18 Participants | 61 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race White | 104 Participants | 55 Participants | 159 Participants |
| Region of Enrollment Brazil | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Portugal | 13 Participants | 6 Participants | 19 Participants |
| Region of Enrollment Spain | 26 Participants | 13 Participants | 39 Participants |
| Region of Enrollment United Kingdom | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 121 Participants | 59 Participants | 180 Participants |
| Sex: Female, Male Female | 71 Participants | 33 Participants | 104 Participants |
| Sex: Female, Male Male | 92 Participants | 47 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 55 / 166 | 26 / 83 |
| other Total, other adverse events | 60 / 163 | 34 / 80 |
| serious Total, serious adverse events | 82 / 163 | 40 / 80 |
Outcome results
Primary
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Time frame: First dose date up to Day 29
Population: Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29 | 30.2 percentage of participants |
| Placebo | Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29 | 33.5 percentage of participants |
p-value: 0.613295% CI: [0.504, 1.321]Log Rank
Secondary
All-cause Mortality Through Day 29
The reported percentage was from the Kaplan-Meier estimate.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | All-cause Mortality Through Day 29 | 25.9 percentage of participants |
| Placebo | All-cause Mortality Through Day 29 | 29.7 percentage of participants |
p-value: 0.388195% CI: [0.497, 1.388]Log Rank
Secondary
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Time frame: First dose date up to last dose date (Maximum: 5 days) plus 30 days
Population: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 50.3 percentage of participants |
| Placebo | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 50.0 percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.
Time frame: First dose date up to last dose date (Maximum: 5 days)
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs) | 4.9 percentage of participants |
| Placebo | Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs) | 1.3 percentage of participants |
Secondary
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time frame: Day 15
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 1 | 0 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 2 | 48.5 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 3 | 5.5 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 4 | 9.2 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 5 | 6.1 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 6 | 8.0 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 7 | 4.9 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 8 | 17.8 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 8 | 18.8 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 1 | 0 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 5 | 11.3 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 2 | 48.8 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 7 | 6.3 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 3 | 2.5 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 6 | 5.0 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15 | Score: 4 | 7.5 percentage of participants |
p-value: 0.8541Proportional odds model
Secondary
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time frame: Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 1 | 11.7 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 2 | 42.9 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 3 | 3.1 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 4 | 4.3 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 5 | 9.2 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 6 | 1.8 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 7 | 1.8 percentage of participants |
| Remdesivir (RDV) | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 8 | 25.2 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 8 | 28.8 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 1 | 16.3 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 5 | 2.5 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 2 | 45.0 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 7 | 2.5 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 3 | 2.5 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 6 | 1.3 percentage of participants |
| Placebo | Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29 | Score: 4 | 1.3 percentage of participants |
p-value: 0.4974Proportional odds model
Secondary
Percentage of Participants With Initiation of IMV Through Day 29
The reported percentage was the cumulative-incidence estimate.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants With Initiation of IMV Through Day 29 | 13.8 percentage of participants |
| Placebo | Percentage of Participants With Initiation of IMV Through Day 29 | 12.8 percentage of participants |
p-value: 0.911695% CI: [0.493, 2.207]Regression, Cox
Secondary
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants With Recovery Independent of Further Worsening Through Day 29 | 66.3 percentage of participants |
| Placebo | Percentage of Participants With Recovery Independent of Further Worsening Through Day 29 | 67.5 percentage of participants |
p-value: 0.753895% CI: [0.819, 1.155]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir (RDV) | Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29 | 57.7 percentage of participants |
| Placebo | Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29 | 63.8 percentage of participants |
p-value: 0.277395% CI: [0.731, 1.091]Cochran-Mantel-Haenszel
Secondary
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Time frame: First dose date up to Day 29
Population: Participants without ESKD at baseline in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir (RDV) | Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29 | 29 days |
| Placebo | Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29 | 29 days |
p-value: 0.4283Wilcoxon (Mann-Whitney)
Secondary
Time to Recovery Independent of Further Worsening by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir (RDV) | Time to Recovery Independent of Further Worsening by Day 29 | 10 days |
| Placebo | Time to Recovery Independent of Further Worsening by Day 29 | 13 days |
Secondary
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Time frame: First dose date up to Day 29
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir (RDV) | Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29 | 20 days |
| Placebo | Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29 | 19 days |