Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003510-12 | EudraCT Number |
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The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.
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The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir (RDV) | Experimental | Participants will receive a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. |
|
| Placebo | Placebo Comparator | Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDV | Drug | Administered as an intravenous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28 | The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Randomization up to Day 28 |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. | First dose date up to last dose date (maximum: 3 days) plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28 | The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. |
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Key Inclusion Criteria:
Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
Either:
Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)
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 |
|---|---|---|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | 85224 | United States | ||
| Arizona Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39699245 | Derived | Rodriguez L, Lee HW, Li J, Martin R, Han D, Xu S, Moshiri J, Peinovich N, Camus G, Perry JK, Hyland RH, Porter DP, Abdelghany M, Gotte M, Hedskog C. SARS-CoV-2 resistance analyses from the Phase 3 PINETREE study of remdesivir treatment in nonhospitalized participants. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0123824. doi: 10.1128/aac.01238-24. Epub 2024 Dec 19. | |
| 37074613 |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
18 months after study completion
A secured external environment with username, password, and RSA code.
630 participants were screened.
Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 18 September 2020. The last study visit occurred on 06 May 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remdesivir (RDV) | Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. |
| FG001 | Placebo | Participants received IV placebo to match (PTM) RDV on Days 1 to 3. |
| 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 | Jan 14, 2021 | Sep 21, 2021 |
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| Placebo to Match RDV | Drug | Administered as an intravenous infusion |
|
| Randomization up to Day 28 |
| Percentage of Participants Who Died by Day 28 | Randomization up to Day 28 |
| Percentage of Participants With COVID-19 Related Hospitalization at Day 28 | COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate. | Randomization up to Day 28 |
| Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14 | The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Randomization up to Day 14 |
| Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14 | The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Randomization up to Day 14 |
| Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7 | The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis. | Baseline up to Day 7 |
| Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus) | The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date. | First Dose Date up to Day 14 |
| Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire | The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptom scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). | First dose date up to Day 28 |
| Percentage of Participants Who Required Oxygen Supplementation by Day 28 | Randomization up to Day 28 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| St Joseph Hospital Eureka | Eureka | California | 95501 | United States |
| St. Joseph Heritage Healthcare | Fullerton | California | 92385 | United States |
| Elevated Health | Huntington Beach | California | 92648 | United States |
| Ruane Clinical Research Group | Los Angeles | California | 90036 | United States |
| LA Universal Center, INC. | Los Angeles | California | 90057 | United States |
| Mills Clinical Research | Los Angeles | California | 90069 | United States |
| Kaiser Permanente Northern California | Oakland | California | 94611 | United States |
| FOMAT Medical Research | Oxnard | California | 93030 | United States |
| UC Davis Health | Sacramento | California | 95817 | United States |
| Kaiser Permanente Northern California, 6600 Bruceville Road | Sacramento | California | 95823 | United States |
| Kaiser Permanente Northern California, 2025 Morse Ave | Sacramento | California | 95825 | United States |
| Kaiser Permanente Northern California, 1200 El Camino Real | San Francisco | California | 94080 | United States |
| Kaiser Permanente Northern California, 2425 Geary Blvd | San Francisco | California | 94115 | United States |
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850 | San Jose | California | 95119 | United States |
| Kaiser Permanente Northern California, 2500 Merced St | San Leandro | California | 94577 | United States |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Premiere Medical Center of Burbank, Inc | Toluca Lake | California | 91602 | United States |
| Kaiser Permanente Northern California, 975 Sereno Drive | Vallejo | California | 94589 | United States |
| New Hope Research Development DBA HCD | Whittier | California | 90603 | United States |
| Centura Health Porter Place | Denver | Colorado | 80210 | United States |
| Nuvance Health | Danbury | Connecticut | 06810 | United States |
| RecioMed Clinical Research Network | Boynton Beach | Florida | 33472 | United States |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | United States |
| Invesclinic | Fort Lauderdale | Florida | 33308 | United States |
| Lawnwood Regional Medical Center | Ft. Pierce | Florida | 34982 | United States |
| Evolution Clinical Trials | Hialeah Gardens | Florida | 33016 | United States |
| Encore Medical Research | Hollywood | Florida | 33201 | United States |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | United States |
| L&C Professional Medical Research Institute | Miami | Florida | 33144 | United States |
| Laguna Clinical Research Associates | Miami | Florida | 33144 | United States |
| CTMD Research, Inc | Palm Springs | Florida | 33406 | United States |
| IMIC Inc | Palmetto Bay | Florida | 33157 | United States |
| Luminous Clinical Research - South Florida Urgent Care | Pembroke Pines | Florida | 33029 | United States |
| St. Josephs Comprehensive Research Institute | Tampa | Florida | 33614 | United States |
| AIDS Research and Treatment Center of the Treasure Coast | Vero Beach | Florida | 32960 | United States |
| Triple O Research Institute PA | West Palm Beach | Florida | 33401 | United States |
| Agile Clinical Research Trials | Atlanta | Georgia | 30328 | United States |
| Mercer University School of Medicine | Macon | Georgia | 31210 | United States |
| Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C. | Burr Ridge | Illinois | 60527 | United States |
| Metro Infectious Disease Consultants | Burr Ridge | Illinois | 60527 | United States |
| NorthStar Medical Center | Chicago | Illinois | 60657 | United States |
| NorthShore University Healthsystem | Evanston | Illinois | 60201 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Holy Cross Hospital, Inc. | Baltimore | Maryland | 21201 | United States |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| South Shore Hospital | South Weymouth | Massachusetts | 02190 | United States |
| VA Boston Healthcare System | West Roxbury | Massachusetts | 02132 | United States |
| Be Well Medical Center | Berkley | Michigan | 48072 | United States |
| Onyx Research Institute | Flint | Michigan | 48532 | United States |
| Memorial Hospital of Gulfport | Gulfport | Mississippi | 39501 | United States |
| Metro Infectious Disease Consultants | Kansas City | Missouri | 64132 | United States |
| Quality Clinical Research Inc. | Omaha | Nebraska | 68114 | United States |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | United States |
| AXCES Research Group | Santa Fe | New Mexico | 87505 | United States |
| New York Presbyterian Hospital | Flushing | New York | 11355 | United States |
| Northwell Health | New Hyde Park | New York | 11040 | United States |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28209 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cherokee Nation WW Hastings Hospital | Tahlequah | Oklahoma | 74464 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 92775 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57108 | United States |
| University of Tennessee Health Science Center | Knoxville | Tennessee | 37920 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| UT Physicians | Bellaire | Texas | 77401 | United States |
| Baylor University Medical Center, 700 Scott and White Dr. | College Station | Texas | 77845 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Care United Research, LLC | Forney | Texas | 75126 | United States |
| VIP Trials | Harlingen | Texas | 78550 | United States |
| University of Texas | Houston | Texas | 77030 | United States |
| The Crofoot Research Center, Inc | Houston | Texas | 77098 | United States |
| Baylor University Medical Center, 1901 North McArthur Blvd | Irving | Texas | 75061 | United States |
| Laguna Clinical Research Associates | Laredo | Texas | 78041 | United States |
| Diagnostic Clinic of Longview - Center for Clinical Research | Longview | Texas | 75605 | United States |
| STAAMP Research | San Antonio | Texas | 78229 | United States |
| Sugar Lakes Family Practice | Sugar Land | Texas | 77479 | United States |
| Baylor University Medical Center, 2201 MacArthur Dr., Suite 100 | Waco | Texas | 76708 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| Intermountain Healthcare | Murray | Utah | 84107 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23249 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| Sound Medical Research | Port Orchard | Washington | 98366 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Providence Medical Research Center | Spokane | Washington | 99204 | United States |
| Wisconsin Corporation for Biomedical Research | Milwaukee | Wisconsin | 53295 | United States |
| Aalborg University Hospital | Aalborg | DK9000 | Denmark |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense University Hospital | Odense | DK5000 | Denmark |
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | BD9 6RJ | United Kingdom |
| University College Hospital | London | NW1 6BN | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Brown SM, Katz MJ, Ginde AA, Juneja K, Ramchandani M, Schiffer JT, Vaca C, Gottlieb RL, Tian Y, Elboudwarej E, Hill JA, Gilson R, Rodriguez L, Hedskog C, Chen S, Montezuma-Rusca JM, Osinusi A, Paredes R. Consistent Effects of Early Remdesivir on Symptoms and Disease Progression Across At-Risk Outpatient Subgroups: Treatment Effect Heterogeneity in PINETREE Study. Infect Dis Ther. 2023 Apr;12(4):1189-1203. doi: 10.1007/s40121-023-00789-y. Epub 2023 Apr 19. |
| 36695483 | 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. |
| 34937145 | Derived | Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, Oguchi G, Ryan P, Nielsen BU, Brown M, Hidalgo A, Sachdeva Y, Mittal S, Osiyemi O, Skarbinski J, Juneja K, Hyland RH, Osinusi A, Chen S, Camus G, Abdelghany M, Davies S, Behenna-Renton N, Duff F, Marty FM, Katz MJ, Ginde AA, Brown SM, Schiffer JT, Hill JA; GS-US-540-9012 (PINETREE) Investigators. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. doi: 10.1056/NEJMoa2116846. Epub 2021 Dec 22. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remdesivir | Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. |
| BG001 | Placebo | Participants received IV PTM RDV on Days 1 to 3. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of race information. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of ethnicity information. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | 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 Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28 | The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Randomization up to Day 28 |
|
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| Primary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. | Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. | Posted | Number | percentage of participants | First dose date up to last dose date (maximum: 3 days) plus 30 days |
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| Secondary | Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28 | The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Modified Full Analysis Set included all participants who were randomized into the study, and received at least 1 dose of study treatment, and enrolled under protocol amendment 2 or later. | Posted | Number | percentage of participants | Randomization up to Day 28 |
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| Secondary | Percentage of Participants Who Died by Day 28 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Randomization up to Day 28 |
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| Secondary | Percentage of Participants With COVID-19 Related Hospitalization at Day 28 | COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization up to Day 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14 | The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Randomization up to Day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14 | The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. | Participants in the modified Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Randomization up to Day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7 | The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis. | Participants in the Virology Analysis Set (all the participants who were randomized into the study, received at least 1 dose of study treatment, and had positive SARS-CoV-2 viral load at baseline) with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/ mililiter (mL) | Baseline up to Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus) | The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | days | First Dose Date up to Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire | The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptom scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Required Oxygen Supplementation by Day 28 | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Randomization up to Day 28 |
|
|
Adverse Events: First dose date up to 3 days plus 30 days; All-Cause Mortality: Randomization to the end of study (maximum: 59 days)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
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 | Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. | 0 | 292 | 5 | 279 | 48 | 279 |
| EG001 | Placebo | Participants received IV PTM RDV on Days 1 to 3. | 1 | 292 | 19 | 283 | 49 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Mitral valve prolapse | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | 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 | Aug 12, 2021 | Nov 3, 2021 | 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 |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Black |
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| Native Hawaiian or Pacific Islander |
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| White |
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| Other |
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| Not Permitted |
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| Not Hispanic or Latino |
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| Not Permitted |
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| Denmark |
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| United Kingdom |
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| Spain |
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