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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005416-22 | EudraCT Number | ||
| DOH-27-012022-4779 | Registry Identifier | South African Clinical Trials Register |
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The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
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The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734â„¢) 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir (RDV) | Experimental | Participants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5. |
|
| Placebo | Placebo Comparator | Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Administered as Intravenous (IV) infusion once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First dose date up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Through Day 29 | The reported percentage was from the Kaplan-Meier estimate. | First dose date up to Day 29 |
| Percentage of Participants With Initiation of IMV Through Day 29 | The reported percentage was the cumulative-incidence estimate. |
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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:
The interval between COVID-19 symptoms onset and randomization is no more than 10 days
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Health System | Birmingham | Alabama | 35205 | United States | ||
| UAB Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38913574 | Derived | Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333. | |
| 36695483 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
258 participants were screened.
Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remdesivir (RDV) | Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2021 | Oct 12, 2022 |
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| RDV Placebo | Drug | Administered as IV saline once daily |
|
| Standard of Care | Drug | Standard of Care Treatment for COVID-19 Infection |
|
| First dose date up to Day 29 |
| 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. | First dose date up to Day 29 |
| 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. | First dose date up to Day 29 |
| 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. | Day 15 |
| 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. | Day 29 |
| 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. | First dose date up to Day 29 |
| 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. | First dose date up to Day 29 |
| 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. | First dose date up to Day 29 |
| 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. | First dose date up to last dose date (Maximum: 5 days) plus 30 days |
| 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. | First dose date up to last dose date (Maximum: 5 days) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Pulmonary Associates of Mobile, P.C. | Mobile | Alabama | 36608 | United States |
| St. Joseph Hospital Eureka | Eureka | California | 95501 | United States |
| Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave | Irvine | California | 92618 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90505 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| North Florida/ South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Genesis Clinical Research | Tampa | Florida | 33603 | United States |
| Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Tulane Medical Center, 2000 Canal St. | New Orleans | Louisiana | 70112 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Wake Forest University Health Sciences | Bethesda | Maryland | 20892 | United States |
| Holy Cross Hospital, 19801 Observation Dr | Germantown | Maryland | 20876 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| St. Clair Nephrology Research | Grosse Pointe Woods | Michigan | 48236 | United States |
| G.V. (Sonny) Montgomery VAMC | Jackson | Michigan | 39216 | United States |
| Mayo Clinic Hospital | Rochester | Minnesota | 55902 | United States |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | United States |
| New York - Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11716 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| PMG Infectious Disease Consultants (administrative) | Portland | Oregon | 92775 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 92037 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital at TMC | Houston | Texas | 77030 | United States |
| VCU Health Medical Center | Richmond | Virginia | 23298 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Providence Health Care | Spokane | Washington | 99204 | United States |
| Providence Health Care, 5633 N Lidgerwood | Spokane | Washington | 99208 | United States |
| MultiCare Good Samaritan Hospital | Tacoma | Washington | 98405 | United States |
| Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas | Campinas | 13060-904 | Brazil |
| Hospital Nossa Senhora das Gracas | Curitiba | 80810-040 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | 01323-020 | Brazil |
| Centro Hospitalar Cova da Beira EPE | Covilha | 6200-251 | Portugal |
| Hospital Nélio Mendonça, | Funchal | 9000-514 | Portugal |
| Centro Hospitalar Lisboa Ocidental | Lisbon | 1449-005 | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo Antonio | Odivelas | 2620-144 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal |
| George Regional Hospital | George | 6529 | South Africa |
| Mediclinic Vergelegen | Somerset West | 7130 | South Africa |
| Hospital Universitario Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital General Universitario de Elche | Elche | 3203 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca | 37007 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Barts Health NHS Trust, The Royal London Hospital | London | E1 1BB | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Derived |
| Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2. |
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.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Clinical Status (8-point Ordinal Scale) | The 8-point Ordinal scale assesses the clinical status of participants:1.Not hospitalized, no limitations on activities;2.Not hospitalized, limitation on activities/requiring home oxygen;3.Hospitalized,not requiring supplemental oxygen,no longer require ongoing medical care; 4.Hospitalized,not requiring supplemental oxygen-require ongoing medical care for COVID-19-specific medical care;5.Hospitalized,supplemental oxygen;6.Hospitalized,on noninvasive ventilation or highflow oxygen devices;7.Hospitalized,on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO);8.Death. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to Day 29 |
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| Secondary | All-cause Mortality Through Day 29 | The reported percentage was from the Kaplan-Meier estimate. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 29 |
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| Secondary | Percentage of Participants With Initiation of IMV Through Day 29 | The reported percentage was the cumulative-incidence estimate. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 29 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | days | First dose date up to Day 29 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | days | First dose date up to Day 29 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Day 15 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Day 29 |
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| 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. | Participants without ESKD at baseline in the Full Analysis Set with available data were analyzed. | Posted | Median | Full Range | days | First dose date up to Day 29 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 29 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 29 |
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| 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. | Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to last dose date (Maximum: 5 days) plus 30 days |
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| 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to last dose date (Maximum: 5 days) |
|
|
All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 55 | 166 | 82 | 163 | 60 | 163 |
| EG001 | 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. | 26 | 83 | 40 | 80 | 34 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatic ischaemia | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bacteroides bacteraemia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Dialysis related complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Glomerular filtration rate abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2022 | Oct 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606551 | remdesivir |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| >= 18 to < 65 Years |
|
| >= 65 Years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
| Spain |
|
| Portugal |
|
| United Kingdom |
|
| Brazil |
|
| Score: 2 |
|
| Score: 3 |
|
| Score: 4 |
|
| Score: 5 |
|
| Score: 6 |
|
| Score: 7 |
|
| Score: 8 |
|
|
|
|
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