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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000842-32 | EudraCT Number | ||
| ISRCTN85762140 | Other Identifier | ISRCTN |
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The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Remdesivir (RDV), 5 Days | Experimental | Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5. |
|
| Part A: Remdesivir, 10 Days | Experimental | Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. |
|
| Part A: SOC Therapy | Active Comparator | Participants will receive continued standard of care therapy. |
|
| Part B: Extension Treatment, Remdesivir 10 Days | Experimental | Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Administered as an intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 | Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group. | Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent. |
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Key Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue | Anaheim | California | 92806 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32821939 | Result | Spinner CD, Gottlieb RL, Criner GJ, Arribas Lopez JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349. | |
| 36695483 |
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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.
1138 participants were screened.
Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 15 March 2020. The last study visit occurred on 26 June 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Remdesivir (RDV) for 5 Days | Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. |
| FG001 | Part A: Remdesivir for 10 Days |
| 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 | Apr 29, 2020 | Oct 22, 2020 |
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|
| Standard of Care | Drug | Standard of Care Treatment for COVID-19 Infection |
|
| First dose date up to last dose date (maximum: 10 days) plus 30 days |
| Alta Bates Summit Medical Center |
| Berkeley |
| California |
| 94609 |
| United States |
| Mills-Peninsula Medical Center | Burlingame | California | 94010 | United States |
| Eden Medical Center | Castro Valley | California | 94546 | United States |
| Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway | Downey | California | 90241 | United States |
| Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave | Fontana | California | 92335 | United States |
| St Joseph Hospital Eureka | Fortuna | California | 95540 | United States |
| Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave. | Harbor City | California | 90710 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave. | Los Angeles | California | 90034 | United States |
| Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue | Los Angeles | California | 91365 | United States |
| Mission Hospital Regional Medical Center | Mission Viejo | California | 92691 | United States |
| Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue | Moreno Valley | California | 92555 | United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Kaiser Permanente Oakland Medical Center | Oakland | California | 94611 | United States |
| Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue | Ontario | California | 91761 | United States |
| The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
| Kaiser Permanente Los Angeles Medical Center,13651 Willard Street | Panorama City | California | 91402 | United States |
| Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue | Riverside | California | 92505 | United States |
| Sutter Medical Center Sacramento, One Medical Plaza | Roseville | California | 95661 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95815 | United States |
| Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue | San Diego | California | 92120-2507 | United States |
| Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd | San Diego | California | 92123 | United States |
| Kaiser Permanente Oakland Medical Center, 1200 El Camino Real | San Francisco | California | 94080 | United States |
| California Pacific Medical Center-Infectious Disease Associates Medical Group | San Francisco | California | 94109 | United States |
| Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd | San Francisco | California | 94115 | United States |
| Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850 | San Jose | California | 95119 | United States |
| Kaiser Permanente Oakland Medical Center, 2500 Merced St | San Leandro | California | 94577 | United States |
| Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway | Santa Clara | California | 95051 | United States |
| Providence St. Johns Medical Center | Santa Monica | California | 90404 | United States |
| Sutter Santa Rosa Regional Hospital | Santa Rosa | California | 95403 | United States |
| Stanford Hospital | Stanford | California | 94305 | United States |
| University of Colorado Denver, University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| SCL Health St. Joseph Hospital, 1375 East 19th Ave | Denver | Colorado | 80208 | United States |
| SCL Health St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| SCL Health St. Joseph Hospital, 200 Exempla Circle. | Lafayette | Colorado | 80026 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Kaiser Permanente Hawaii Moanalua Medical Center | Honolulu | Hawaii | 96819 | United States |
| Cook County General Hospital | Chicago | Illinois | 60612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46077 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham & Women's Hospital and Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| The University of Michigan Hospitals and Health Systems | Ann Arbor | Michigan | 48109-5378 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Providence St Patrick Hospital and International Heart Institute of MT Foundation | Missoula | Montana | 59802 | United States |
| Darmouth-Hitchhock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack Medical Center | Hackensack | New Jersey | 07601 | United States |
| Robert Wood Johnson University Hospital Somerset | Hillsborough | New Jersey | 08844 | United States |
| Robert Wood Johnson University Hospital Somerset, 1 RWJ Place | New Brunswick | New Jersey | 08901 | United States |
| Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue | Newark | New Jersey | 07112 | United States |
| St. Joseph's University Medical Center | Paterson | New Jersey | 07503 | United States |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| Danbury Hospital | Lagrangeville | New York | 12540 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| North Shore University Hospital, 270-05 76th Ave | New Hyde Park | New York | 11040 | United States |
| Icahn School of Medicine at Mount Sinai, 350 East 17th Street | New York | New York | 10003 | United States |
| Icahn School of Medicine at Mount Sinai, 1000 10th Avenue | New York | New York | 10019 | United States |
| Icahn School of Medicine at Mount Sinai, 440 West 114th St. | New York | New York | 10025 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical College/NYU Presbyterian Hospital | New York | New York | 10065 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| James J. Peters Veterans Administration Medical Center | The Bronx | New York | 10468 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave | Hillsboro | Oregon | 97124 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Kaiser Sunnyside Medical Center | Portland | Oregon | 97227 | United States |
| Hospital of the University of Pennsylvania, 51 N. 31st Street | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| Prisma Health Richland Hospital, 701 Grove Road | Greenville | South Carolina | 29605 | United States |
| The Liver Institute of Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic | Dallas | Texas | 75235 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd. | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd | Dallas | Texas | 75390 | United States |
| Baylor University Medical Center, 1400 8th Ave | Fort Worth | Texas | 76104 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Baylor University Medical Center, 2401 S. 31st St. | Temple | Texas | 76508 | United States |
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| VCU Health Medical Center | Richmond | Virginia | 23298 | United States |
| Providence Medical Research Center | Everett | Washington | 98201 | United States |
| Kadlec Regional Medical Center | Kennewick | Washington | 99336 | United States |
| Providence St. Peter Hospital | Olympia | Washington | 98506 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Swedish Center for Comprehensive Care | Seattle | Washington | 98104 | United States |
| MultiCare Deaconess Hospital | Spokane | Washington | 99204 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| CHU Pellegrin | Bordeaux | 33076 | France |
| CHU de Montpellier-Hopital Gui de Chauliac | Montpelier Cedex 5 | 34295 | France |
| CHU de Nantes-Hotel Dieu | Nantes | 44035 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie | Berlin | 13353 | Germany |
| Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | 24105 | Germany |
| Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie | Leipzig | 4129 | Germany |
| Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2 | Munich | 81675 | Germany |
| Klinik für Hämatologie, Onkologie, Immunologie | München | 80804 | Germany |
| Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP) | Stuttgart | 70376 | Germany |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| UOC Malattie Infettive, ASST Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| ASST degli Spedali Civili di Brescia | Brescia | 25123 | Italy |
| ASST di Cremona - Azienda Socio Sanitaria Territor | Cremona | 26100 | Italy |
| UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| UOC Malattie Infettive, IRCCS Ospedale San Raffaele | Milan | 20127 | Italy |
| ASST Fatebenefratelli Sacco | Milan | 20157 | Italy |
| UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova | Padova PD | 35121 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43126 | Italy |
| Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Ospedale Guglielmo da Saliceto AUSL di Piacenza | Piacenza | Italy |
| UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S. | Roma | 00149 | Italy |
| Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia | Torino | 10149 | Italy |
| Yokohama Municipal Citizen's Hospital | Kanagawa | 240-8555 | Japan |
| Nagoya City East Medical Center | Nagoya | 464-8547 | Japan |
| Tokyo Metropolitan Bokutoh Hospital | Tokyo | 130-8575 | Japan |
| Amsterdam University Medical Centre - Location AMC | Amsterdam | 1105 AZ | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Erasmus Medical Centre | Rotterdam | 3015 GD | Netherlands |
| National University Hospital | Singapore | 119228 | Singapore |
| Singapore General Hospital | Singapore | 169856 | Singapore |
| National Centre for Infectious Diseases, Tan Tock Seng Hospital | Singapore | 308442 | Singapore |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Seoul Medical Center | Seoul | 02053 | South Korea |
| National Medical Center | Seoul | 04564 | South Korea |
| Hospital Principe de Asturias | Alcalá de Henares | Madrid | 28805 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital Universitario Cruces | Bizkaia | 48903 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundación Jiménez DÃaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Sahlgrenska University Hospital, Ostra | Gothenburg | 41685 | Sweden |
| SUS (Skanes University Hospital) | Malmö | 20502 | Sweden |
| Karolinska University Hospital | Stockholm | SE-141 86 | Sweden |
| Hopitaux Universitaires de Genève | Geneva | 1211 | Switzerland |
| Ospedale Regionale di Locarno La Carità | Lugano | CH- 6900 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Imperial College NHS Trust | London | Greater London | W2 1NY | United Kingdom |
| NHS Lothian, Royal lnfirmary of Edinburgh | Edinburgh | EH4 2XU | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Hull | HU16 5JQ | United Kingdom |
| Royal Lancaster Hospital | Lancaster | LA1 4RP | United Kingdom |
| Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Northwick Park Hospital | London | HA1 3UJ | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| King's College Hospital NHS Trust | London | SE5 9RS | United Kingdom |
| University College London | London | WC1E 6JF | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | M23 9LT | United Kingdom |
| Pennine Acute Hospitals NHS Trust | Manchester | M8 5RB | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8BG | United Kingdom |
| Sheffield Teaching Hospitals | Sheffield | S10 2JF | 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. |
| 34350582 | Derived | Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962. |
Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
| FG002 | Part A: SOC Therapy | Participants received continued SOC therapy. |
| FG003 | Part B: Extension Treatment, Remdesivir for 10 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group).
Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into Part B of the study and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Remdesivir for 5 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. |
| BG001 | Part A: Remdesivir for 10 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. |
| BG002 | Part A: SOC Therapy | Participants received continued SOC therapy. |
| BG003 | Part B: Extension Treatment, Remdesivir for 10 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. |
| BG004 | 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, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of race information. | Count of Participants | Participants | No |
| ||||||||||||||
| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of ethnicity information. | Count of Participants | Participants | No |
| ||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 | Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group. | Full Analysis Set (FAS) included all participants who were randomized into Part A of the study and received at least 1 dose of study treatment if randomized to 1 of the RDV treatment groups. Participants in the SOC arm who had protocol Day 1 visit were included in the FAS. | Posted | Number | percentage of participants | Day 11 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent. | Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group). | Posted | Number | 95% Confidence Interval | percentage of participants | First dose date up to last dose date (maximum: 10 days) plus 30 days |
|
First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days.
Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and 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 | Part A: Remdesivir for 5 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. | 2 | 191 | 9 | 191 | 41 | 191 |
| EG001 | Part A: Remdesivir for 10 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. | 3 | 193 | 10 | 193 | 42 | 193 |
| EG002 | Part A: SOC Therapy | Participants received continued SOC therapy. | 4 | 200 | 18 | 200 | 30 | 200 |
| EG003 | Part B: Extension Treatment, Remdesivir for 10 Days | Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. | 13 | 503 | 40 | 503 | 113 | 503 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | 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: GS-US-540-5774-appendix-16.1.9-SAP part A_f-redact | Jun 26, 2020 | Oct 22, 2020 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: GS-US-540-5774-appendix-16.1.9-SAP part B_f-redact | Sep 16, 2020 | Oct 22, 2020 | SAP_002.pdf |
Not provided
| 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
| >= 65 Years |
|
| Male |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Not Permitted |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Missing |
|
| Spain |
|
| Italy |
|
| United Kingdom |
|
| South Korea |
|
| Germany |
|
| Singapore |
|
| Hong Kong |
|
| Switzerland |
|
| France |
|
| Taiwan |
|
| Netherlands |
|
| Japan |
|
| Sweden |
|
| Title | Measurements |
|---|---|
|
| Score: 3 |
|
| Score: 4 |
|
| Score: 5 |
|
| Score: 6 |
|
| Score: 7 |
|
Primary analysis
| Proportional odds model |
| 0.1826 |
P-value was calculated using proportional odds model with treatment as the independent variable. |
| Odds Ratio (OR) |
| 1.31 |
| 2-Sided |
| 95 |
| 0.880 |
| 1.952 |
| Superiority |
| Secondary analysis | Proportional odds model | 0.0168 | P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate. | Odds Ratio (OR) | 1.65 | 2-Sided | 95 | 1.095 | 2.497 | Superiority |
| Secondary analysis | Proportional odds model | 0.2186 | P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate. | Odds Ratio (OR) | 1.29 | 2-Sided | 95 | 0.862 | 1.917 | Superiority |
|
|
|