COVID-19 Clinical Trial
Official title:
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
| Verified date | January 2021 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1113 |
| Est. completion date | June 26, 2020 |
| Est. primary completion date | April 29, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Key Inclusion Criteria: - Willing and able to provide written informed consent prior to performing study procedures (participants = 18 years of age) or assent (participants = 12 and < 18 years of age) prior to performing study procedures. For participants = 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test = 4 days before randomization - Currently hospitalized and requiring medical care for COVID-19 - Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening - Radiographic evidence of pulmonary infiltrates Key Exclusion Criteria: - Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 - Requiring mechanical ventilation at screening - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) - Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants = 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | |
| France | CHU Pellegrin | Bordeaux | |
| France | CHU de Montpellier-Hopital Gui de Chauliac | Montpelier Cedex 5 | |
| France | CHU de Nantes-Hotel Dieu | Nantes | |
| France | Hopital Saint Antoine | Paris | |
| France | Hopital Saint-Louis | Paris | |
| Germany | Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie | Berlin | |
| Germany | Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie | Düsseldorf | |
| Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | |
| Germany | Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie | Leipzig | |
| Germany | Klinik für Hämatologie, Onkologie, Immunologie | München | |
| Germany | Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2 | Munich | |
| Germany | Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP) | Stuttgart | |
| Hong Kong | Prince of Wales Hospital | Hong Kong | |
| Hong Kong | Princess Margaret Hospital | Hong Kong | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Italy | UOC Malattie Infettive, ASST Papa Giovanni XXIII | Bergamo | |
| Italy | ASST degli Spedali Civili di Brescia | Brescia | |
| Italy | ASST di Cremona - Azienda Socio Sanitaria Territor | Cremona | |
| Italy | UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | |
| Italy | ASST Fatebenefratelli Sacco | Milano | |
| Italy | UOC Malattie Infettive, IRCCS Ospedale San Raffaele | Milano | |
| Italy | UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova | Padova PD | |
| Italy | Azienda Ospedaliero Universitaria di Parma | Parma | |
| Italy | Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo | Pavia | |
| 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 | |
| Italy | Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia | Torino | |
| Japan | Yokohama Municipal Citizen's Hospital | Kanagawa | |
| Japan | Nagoya City East Medical Center | Nagoya | |
| Japan | Tokyo Metropolitan Bokutoh Hospital | Tokyo | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | National Medical Center | Seoul | |
| Korea, Republic of | Seoul Medical Center | Seoul | |
| Netherlands | Amsterdam University Medical Centre - Location AMC | Amsterdam | |
| Netherlands | Leiden University Medical Center | Leiden | |
| Netherlands | Erasmus Medical Centre | Rotterdam | |
| Singapore | National Centre for Infectious Diseases, Tan Tock Seng Hospital | Singapore | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Singapore General Hospital | Singapore | |
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | |
| Spain | Hospital Principe de Asturias | Alcalá De Henares | Madrid |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari de Bellvitge | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario Cruces | Bizkaia | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Regional Universitario de Málaga | Málaga | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitari i Politecnic La Fe | Valencia | |
| Sweden | Sahlgrenska University Hospital, Ostra | Gothenburg | |
| Sweden | SUS (Skanes University Hospital) | Malmo | |
| Sweden | Karolinska University Hospital | Stockholm | |
| Switzerland | Hopitaux Universitaires de Genève | Genève 14 | |
| Switzerland | Ospedale Regionale di Locarno La Carità | Lugano | |
| Switzerland | Universitätsspital Zürich | Zürich | |
| Taiwan | Kaohsiung Veterans General Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | National Taiwan University Hospital | Taipei City | |
| United Kingdom | NHS Lothian, Royal lnfirmary of Edinburgh | Edinburgh | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Hull University Teaching Hospitals NHS Trust | Hull | |
| United Kingdom | Royal Lancaster Hospital | Lancaster | |
| United Kingdom | Liverpool University Hospital | Liverpool | |
| United Kingdom | Imperial College NHS Trust | London | Greater London |
| United Kingdom | King's College Hospital NHS Trust | London | |
| United Kingdom | Northwick Park Hospital | London | |
| United Kingdom | Royal Free London NHS Foundation Trust | London | |
| United Kingdom | University College London | London | |
| United Kingdom | Manchester University NHS Foundation Trust | Manchester | |
| United Kingdom | Manchester University NHS Foundation Trust | Manchester | |
| United Kingdom | Pennine Acute Hospitals NHS Trust | Manchester | |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Sheffield Teaching Hospitals | Sheffield | |
| United States | Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue | Anaheim | California |
| United States | The University of Michigan Hospitals and Health Systems | Ann Arbor | Michigan |
| United States | Virginia Hospital Center | Arlington | Virginia |
| United States | University of Colorado Denver, University of Colorado Hospital | Aurora | Colorado |
| United States | Alta Bates Summit Medical Center | Berkeley | California |
| United States | Brigham & Women's Hospital and Harvard Medical School | Boston | Massachusetts |
| United States | Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Jacobi Medical Center | Bronx | New York |
| United States | James J. Peters Veterans Administration Medical Center | Bronx | New York |
| United States | Mills-Peninsula Medical Center | Burlingame | California |
| United States | Eden Medical Center | Castro Valley | California |
| United States | Cook County General Hospital | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Prisma Health Richland Hospital | Columbia | South Carolina |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | The Liver Institute of Methodist Dallas Medical Center | Dallas | Texas |
| United States | UT Southwestern Medical Center Amelia Court, HIV Research Clinic | Dallas | Texas |
| United States | UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd. | Dallas | Texas |
| United States | UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd | Dallas | Texas |
| United States | Rose Medical Center | Denver | Colorado |
| United States | SCL Health St. Joseph Hospital | Denver | Colorado |
| United States | SCL Health St. Joseph Hospital, 1375 East 19th Ave | Denver | Colorado |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway | Downey | California |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Providence Medical Research Center | Everett | Washington |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave | Fontana | California |
| United States | Baylor University Medical Center, 1400 8th Ave | Fort Worth | Texas |
| United States | St Joseph Hospital Eureka | Fortuna | California |
| United States | Prisma Health Richland Hospital, 701 Grove Road | Greenville | South Carolina |
| United States | Hackensack Medical Center | Hackensack | New Jersey |
| United States | Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave. | Harbor City | California |
| United States | Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave | Hillsboro | Oregon |
| United States | Robert Wood Johnson University Hospital Somerset | Hillsborough | New Jersey |
| United States | Kaiser Permanente Hawaii Moanalua Medical Center | Honolulu | Hawaii |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | IU Health Methodist Hospital | Indianapolis | Indiana |
| United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
| United States | Jamaica Hospital Medical Center | Jamaica | New York |
| United States | Kadlec Regional Medical Center | Kennewick | Washington |
| United States | SCL Health St. Joseph Hospital, 200 Exempla Circle. | Lafayette | Colorado |
| United States | Danbury Hospital | Lagrangeville | New York |
| United States | Darmouth-Hitchhock Medical Center | Lebanon | New Hampshire |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue | Los Angeles | California |
| United States | Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave. | Los Angeles | California |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Hennepin Healthcare | Minneapolis | Minnesota |
| United States | Mission Hospital Regional Medical Center | Mission Viejo | California |
| United States | Providence St Patrick Hospital and International Heart Institute of MT Foundation | Missoula | Montana |
| United States | Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue | Moreno Valley | California |
| United States | El Camino Hospital | Mountain View | California |
| United States | Robert Wood Johnson University Hospital Somerset, 1 RWJ Place | New Brunswick | New Jersey |
| United States | Yale University | New Haven | Connecticut |
| United States | North Shore University Hospital, 270-05 76th Ave | New Hyde Park | New York |
| United States | Tulane University | New Orleans | Louisiana |
| United States | Columbia University Irving Medical Center | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai, 1000 10th Avenue | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai, 350 East 17th Street | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai, 440 West 114th St. | New York | New York |
| United States | Weill Cornell Medical College/NYU Presbyterian Hospital | New York | New York |
| United States | Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue | Newark | New Jersey |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | Kaiser Permanente Oakland Medical Center | Oakland | California |
| United States | Providence St. Peter Hospital | Olympia | Washington |
| United States | Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue | Ontario | California |
| United States | The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange | California |
| United States | Kaiser Permanente Los Angeles Medical Center,13651 Willard Street | Panorama City | California |
| United States | St. Joseph's University Medical Center | Paterson | New Jersey |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Hospital of the University of Pennsylvania, 51 N. 31st Street | Philadelphia | Pennsylvania |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Kaiser Sunnyside Medical Center | Portland | Oregon |
| United States | Maine Medical Center | Portland | Maine |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Providence St. Vincent Medical Center | Portland | Oregon |
| United States | The Miriam Hospital | Providence | Rhode Island |
| United States | VCU Health Medical Center | Richmond | Virginia |
| United States | Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue | Riverside | California |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Sutter Medical Center Sacramento, One Medical Plaza | Roseville | California |
| United States | Sutter Medical Center Sacramento | Sacramento | California |
| United States | University of Utah Health | Salt Lake City | Utah |
| United States | Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue | San Diego | California |
| United States | Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd | San Diego | California |
| United States | California Pacific Medical Center-Infectious Disease Associates Medical Group | San Francisco | California |
| United States | Kaiser Permanente Oakland Medical Center, 1200 El Camino Real | San Francisco | California |
| United States | Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd | San Francisco | California |
| United States | Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850 | San Jose | California |
| United States | Kaiser Permanente Oakland Medical Center, 2500 Merced St | San Leandro | California |
| United States | Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway | Santa Clara | California |
| United States | Providence St. Johns Medical Center | Santa Monica | California |
| United States | Sutter Santa Rosa Regional Hospital | Santa Rosa | California |
| United States | Swedish Center for Comprehensive Care | Seattle | Washington |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | Holy Cross Hospital | Silver Spring | Maryland |
| United States | MultiCare Deaconess Hospital | Spokane | Washington |
| United States | Stanford Hospital | Stanford | California |
| United States | MultiCare Tacoma General Hospital | Tacoma | Washington |
| United States | St Joseph Medical Center | Tacoma | Washington |
| United States | Baylor University Medical Center, 2401 S. 31st St. | Temple | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Spinner CD, Gottlieb RL, Criner GJ, Arribas López 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, Blai — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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. | First dose date up to last dose date (maximum: 10 days) plus 30 days |
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