A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-573) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
Latest Information Update: 02 Dec 2022
At a glance
- Drugs Remdesivir (Primary)
- Indications COVID 2019 infections; COVID-19 pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms SIMPLE; SIMPLE-moderate
- Sponsors Gilead Sciences
- 25 Oct 2020 Results presented at the IDWeek 2020
- 25 Oct 2020 Results (n=584) assessing baseline characteristics associated with clinical improvement at day 14, presented at the IDWeek 2020
- 28 Aug 2020 According to a Gilead Sciences media release, based on the SIMPLE-moderate (Study GS-US-540-5774) and ACTT-1 studies, the USA Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
Most Recent Events
Trial Overview
Outcome
Purpose
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.
Comments
According to a Gilead Sciences media release, based on the SIMPLE-moderate (Study GS-US-540-5774) and ACTT-1 studies, the USA Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
Primary Endpoints
The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 (5 days randomized)
On day 11, patients randomized to the 5-day remdesivir group on the 7-point ordinal scale compared with those randomized to standard care [1]
The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 (10 days randomized)
The difference in clinical status distribution on day 11 between the 10-day remdesivir and standard care groups [1]
The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11
[ Time Frame: Day 11 ]
The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. 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.
Other Endpoints
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
description: 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.
time_frame: First dose date up to last dose date (maximum: 10 days) plus 30 days [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
| COVID-19 pneumonia | treatment | moderate |
Subjects
- Subject Type patients
-
Number
Planned: 1600
Actual: 596
- Sex male & female
- Age Group ≥ 12 years (median age- 57 year); adolescent; adult; child; elderly
Patient Inclusion Criteria
Key - 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
Patient 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.
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04292730 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2020-000842-32 | European Clinical Trials Database |
| GS-US540-5774 | Gilead Sciences |
| 85762140 | ISRCTN: Current Controlled Trials |
| JapicCTI205256 | Japan Pharmaceutical Information Center - Clinical Trials Information |
| GS-US540-5774IRAS282026CPMS45459 | - |
| 20NE0105 | - |
Organisations
- Sponsors Gilead Sciences
- Affiliations Gilead Sciences
Trial Dates
-
Initiation Dates
Planned : 01 Mar 2020
Actual : 15 Mar 2020
-
Primary Completion Dates
Planned : 01 Jun 2020
Actual : 29 Apr 2020
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End Dates
Planned : 01 Jun 2020
Actual : 26 Jun 2020
Substudies/Extensions
An expansion phase of the study was added to enroll up to 1,000 additional patients with moderate disease.
Other Details
- Design multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase III
- Location China; England; Europe; France; Germany; Hong Kong; Italy; Japan; Netherlands; North America; Scotland; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| RemdesivirPrimary Drug | Intravenous | Infusion, Lyophilised |
Part A: Remdesivir (RDV), 5 Days
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. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)
Part A: Remdesivir, 10 Days
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. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)
Part B: Extension Treatment, Remdesivir 10 Days
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. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)
Part A: SOC Therapy
Participants will receive continued standard of care therapy. Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)
Results
Therapeutic efficacy
Updated results from phase III SIMPLE-moderate trial demonstrated that treatment with remdesivir improved COVID-19 symptoms statistically and significantly at day 5 compared to day 11 as compared to standard of care. The odds of improvement with the day 10 treatment group when compared to those receiving only standard of care were numerically favourable, but not statistically significantly different. The mortality reported was less than or equal to 2 percent in all treatment groups. Earlier data from the trial showed greater clinical benefit in higher number of patients than 10 days regimen. In the 5-day treatment group, 76% (146/191) of patients achieved clinical improvement at Day 11, showing statistical significance for a ≥ 1-point improvement in ordinal scale compared with 66% (132/200) of patients in the standard of care alone, (p = 0.026). In the 10-day treatment group, 70% (135/193) of patients achieved clinical improvement at Day 11. In the 5-day and 10 day treatment group, 70% (134/191) and 65% (26/193) of patients showed a ≥ 2-point improvement in ordinal scale at Day 11 compared with 61% (121/200) of patients in the standard of care alone. Number of patients who required oxygen support in 5-day, 10-day and SoC treatment group were 12, 13 and 22, respectively. No patient was died due to worsening disease in 5-day course treatment whereas 2 and 4 patients were died in 10-day and SoC treatment group. Patients with moderate disease who received the 5-day remdesivir plus standard-of-care treatment were 65% more likely to have clinical improvement at Day 11 compared with those in the standard of care group as assessed by a 7-point ordinal score (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical condition with the 10-day treatment course of remdesivir versus standard of care also showed trend toward improvement but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18) [3] .
Adverse events
In the phase III SIMPLE trial (SIMPLE moderate), conducted in patients with moderate manifestations of COVID-19, remdesivir in combination with standard of care was generally well-tolerated in both the 5-day and 10-day treatment groups and did not showed any new safety signal. Adverse events were reported in 51% (97/191) patients in 5-day course, in 55% (106/193) patients in 10-day course and 45% (90/200) patients in standard-of-care group. Grade >3 AE were reported in 10% (20/191) patients in 5-day course, in 11% (21/193) patients in 10-day course and 12% (24/200) patients in standard-of-care group. Serious events were reported in 4% (8/191) patients in 5-day course, in 4% (7/193) patients in 10-day course and 9% (18/200) patients in standard-of-care group. The most common adverse events occurring in more than 5 percent of patients in both treatment groups were nausea (5-day: 10% / 10-day: 9% / SOC: 3%), diarrhoea (5-day: 5% / 10-day: 5% / SOC: 7%) and headache (5-day: 5% / 10-day: 5% / SOC: 3%) [3] .
Publications
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Spinner CD, Gottlieb RL, Criner GJ, Arribas Lopez JR, Cattelan AM, Soriano Viladomiu A, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. . JAMA 2020;.
PubMed | CrossRef Fulltext -
Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19. Media-Rel 2020;.
Media Release -
Castagna A, Hui DSC, Mullane KM, Jain M, Galli M, Chang S-C, et al. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19. IDW-2020 2020; abstr. 548.
Available from: URL: https://www.eventscribe.net/2020/IDWeek/ajaxcalls/PosterInfo.asp?efp=VFhWUUpXVFA2ODg4&PosterID=292426&rnd=1.620388E-02 -
Marty FM, Malhotra P, Gottlieb RL, Tashima KT, Galli M, Chai LYA, et al. Remdesivir vs Standard Care in Patients with Moderate covid-19. IDW-2020 2020; abstr. N/A.
Available from: URL: https://www.eventscribe.net/2020/IDWeek/fsPopup.asp?Mode=presInfo&PresentationID=775583 -
Tsang O, Brar I, Spinner C, Robinson P, Roestenberg M, Calmy A, et al. Impact of Baseline Alanine Aminotransferase Levels on the Safety and Efficacy of Remdesivir in Moderate Covid-19 Patients. AASLD-2020 2020; abstr. 0120.
Available from: URL: https://aasld.confex.com/aasld/2020/meetingapp.cgiPaper/23623
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Clinical Trials Mailbox
Flowers Building, Granta Park Great Abington, Cambridge Postcode: CB21 6GT United Kingdom Telephone: +441223897284 clinical.trials@gilead.com |
Gilead Sciences International Ltd. | United-Kingdom |
| Gilead Study Director | Gilead Sciences |
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|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Alta Bates Summit Medical Center | Berkeley, California | USA |
| Amsterdam University Medical Centre - Location AMC | Amsterdam | Netherlands |
| ASST degli Spedali Civili di Brescia | Brescia | Italy |
| ASST di Cremona - Azienda Socio Sanitaria Territor | Cremona | Italy |
| ASST Fatebenefratelli Sacco | Milano | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| Baylor University Medical Center | Dallas, Texas | USA |
| Baylor University Medical Center, 1400 8th Ave | Fort Worth, Texas | USA |
| Baylor University Medical Center, 2401 S. 31st St. | Temple, Texas | USA |
| Brigham & Women's Hospital and Harvard Medical School | Boston, Massachusetts | USA |
| California Pacific Medical Center-Infectious Disease Associates Medical Group | San Francisco, California | USA |
| Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center | Boston, Massachusetts | USA |
| Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie | Berlin | Germany |
| China Medical University Hospital | Taichung | Taiwan |
| CHU de Montpellier-Hopital Gui de Chauliac | Montpelier Cedex 5 | France |
| CHU de Nantes-Hotel Dieu | Nantes | France |
| CHU Pellegrin | Bordeaux | France |
| Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia | Torino | Italy |
| Columbia University Irving Medical Center | New York, New York | USA |
| Complejo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Cook County General Hospital | Chicago, Illinois | USA |
| Danbury Hospital | Lagrangeville, New York | USA |
| Darmouth-Hitchhock Medical Center | Lebanon, New Hampshire | USA |
| Derriford Hospital | Plymouth | United-Kingdom |
| Duke University Medical Center | Durham, North Carolina | USA |
| Eden Medical Center | Castro Valley, California | USA |
| El Camino Hospital | Mountain View, California | USA |
| Erasmus Medical Centre | Rotterdam | Netherlands |
| Gilead Sciences |
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|
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|
| Gilead Sciences International Ltd. | Great Abington, Cambridge | United-Kingdom |
| Hackensack Medical Center | Hackensack, New Jersey | USA |
| Hennepin Healthcare | Minneapolis, Minnesota | USA |
| Henry Ford Health System | Detroit, Michigan | USA |
| Hoag Memorial Hospital Presbyterian | Newport Beach, California | USA |
| Holy Cross Hospital | Silver Spring, Maryland | USA |
| Hopital Saint Antoine | Paris | France |
| Hopital Saint-Louis | Paris | France |
| Hopitaux Universitaires de Genève | Genève 14 | Switzerland |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania | USA |
| Hospital of the University of Pennsylvania, 51 N. 31st Street | Philadelphia, Pennsylvania | USA |
| Hospital Principe de Asturias | Alcalá De Henares, Madrid | Spain |
| Hospital Regional Universitario de Málaga | Málaga | Spain |
| Hospital Universitari de Bellvitge | Barcelona | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario Cruces | Bizkaia | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Virgen del Rocio | Sevilla | Spain |
| Houston Methodist Hospital | Houston, Texas | USA |
| Hull University Teaching Hospitals NHS Trust | Hull | United-Kingdom |
| Icahn School of Medicine at Mount Sinai | New York, New York | USA |
| Icahn School of Medicine at Mount Sinai, 1000 10th Avenue | New York, New York | USA |
| Icahn School of Medicine at Mount Sinai, 350 East 17th Street | New York, New York | USA |
| Icahn School of Medicine at Mount Sinai, 440 West 114th St. | New York, New York | USA |
| Imperial College NHS Trust | London, Greater London | United-Kingdom |
| Inova Fairfax Hospital | Falls Church, Virginia | USA |
| IU Health Methodist Hospital | Indianapolis, Indiana | USA |
| Jacobi Medical Center | Bronx, New York | USA |
| Jamaica Hospital Medical Center | Jamaica, New York | USA |
| James J. Peters Veterans Administration Medical Center | Bronx, New York | USA |
| Kadlec Regional Medical Center | Kennewick, Washington | USA |
| Kaiser Permanente Hawaii Moanalua Medical Center | Honolulu, Hawaii | USA |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue | Riverside, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue | Ontario, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave. | Harbor City, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue | Anaheim, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue | San Diego, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue | Los Angeles, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave. | Los Angeles, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway | Downey, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd | San Diego, California | USA |
| Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave | Fontana, California | USA |
| Kaiser Permanente Los Angeles Medical Center,13651 Willard Street | Panorama City, California | USA |
| Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue | Moreno Valley, California | USA |
| Kaiser Permanente Oakland Medical Center | Oakland, California | USA |
| Kaiser Permanente Oakland Medical Center, 1200 El Camino Real | San Francisco, California | USA |
| Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd | San Francisco, California | USA |
| Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850 | San Jose, California | USA |
| Kaiser Permanente Oakland Medical Center, 2500 Merced St | San Leandro, California | USA |
| Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway | Santa Clara, California | USA |
| Kaiser Sunnyside Medical Center | Portland, Oregon | USA |
| Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave | Hillsboro, Oregon | USA |
| Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan |
| Karolinska University Hospital | Stockholm | Sweden |
| King's College Hospital NHS Trust | London | United-Kingdom |
| Klinik für Hämatologie, Onkologie, Immunologie | München | Germany |
| Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2 | Munich | Germany |
| Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie | Leipzig | Germany |
| Kyungpook National University Hospital | Daegu | South-Korea |
| Leiden University Medical Center | Leiden | Netherlands |
| Liverpool University Hospital | Liverpool | United-Kingdom |
| Maine Medical Center | Portland, Maine | USA |
| Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo | Pavia | Italy |
| Manchester University NHS Foundation Trust | Manchester | United-Kingdom |
| Mayo Clinic | Rochester, Minnesota | USA |
| Mills-Peninsula Medical Center | Burlingame, California | USA |
| Mission Hospital Regional Medical Center | Mission Viejo, California | USA |
| MultiCare Deaconess Hospital | Spokane, Washington | USA |
| MultiCare Tacoma General Hospital | Tacoma, Washington | USA |
| Nagoya City East Medical Center | Nagoya | Japan |
| National Centre for Infectious Diseases, Tan Tock Seng Hospital | Singapore | Singapore |
| National Medical Center | Seoul | South-Korea |
| National Taiwan University Hospital | Taipei City | Taiwan |
| National University Hospital | Singapore | Singapore |
| NHS Lothian, Royal lnfirmary of Edinburgh | Edinburgh | United-Kingdom |
| North Shore University Hospital | Manhasset, New York | USA |
| North Shore University Hospital, 270-05 76th Ave | New Hyde Park, New York | USA |
| Northwick Park Hospital | London | United-Kingdom |
| Ospedale Guglielmo da Saliceto AUSL di Piacenza | Piacenza | Italy |
| Ospedale Regionale di Locarno La Carità | Lugano | Switzerland |
| Pennine Acute Hospitals NHS Trust | Manchester | United-Kingdom |
| Prince of Wales Hospital | Hong Kong | Hong-Kong |
| Princess Margaret Hospital | Hong Kong | Hong-Kong |
| Prisma Health Richland Hospital | Columbia, South Carolina | USA |
| Prisma Health Richland Hospital, 701 Grove Road | Greenville, South Carolina | USA |
| Providence Medical Research Center | Everett, Washington | USA |
| Providence Portland Medical Center | Portland, Oregon | USA |
| Providence St Patrick Hospital and International Heart Institute of MT Foundation | Missoula, Montana | USA |
| Providence St. Johns Medical Center | Santa Monica, California | USA |
| Providence St. Peter Hospital | Olympia, Washington | USA |
| Providence St. Vincent Medical Center | Portland, Oregon | USA |
| Queen Elizabeth University Hospital | Glasgow | United-Kingdom |
| Queen Mary Hospital | Hong Kong | Hong-Kong |
| Robert Wood Johnson University Hospital Somerset | Hillsborough, New Jersey | USA |
| Robert Wood Johnson University Hospital Somerset, 1 RWJ Place | New Brunswick, New Jersey | USA |
| Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue | Newark, New Jersey | USA |
| Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP) | Stuttgart | Germany |
| Rose Medical Center | Denver, Colorado | USA |
| Royal Free London NHS Foundation Trust | London | United-Kingdom |
| Royal Lancaster Hospital | Lancaster | United-Kingdom |
| Rush University Medical Center | Chicago, Illinois | USA |
| Sahlgrenska University Hospital, Ostra | Gothenburg | Sweden |
| SCL Health St. Joseph Hospital | Denver, Colorado | USA |
| SCL Health St. Joseph Hospital, 1375 East 19th Ave | Denver, Colorado | USA |
| SCL Health St. Joseph Hospital, 200 Exempla Circle. | Lafayette, Colorado | USA |
| Seoul Medical Center | Seoul | South-Korea |
| Sheffield Teaching Hospitals | Sheffield | United-Kingdom |
| Singapore General Hospital | Singapore | Singapore |
| St Joseph Hospital Eureka | Fortuna, California | USA |
| St Joseph Medical Center | Tacoma, Washington | USA |
| St. Joseph's University Medical Center | Paterson, New Jersey | USA |
| Stanford Hospital | Stanford, California | USA |
| SUS (Skanes University Hospital) | Malmo | Sweden |
| Sutter Medical Center Sacramento | Sacramento, California | USA |
| Sutter Medical Center Sacramento, One Medical Plaza | Roseville, California | USA |
| Sutter Santa Rosa Regional Hospital | Santa Rosa, California | USA |
| Swedish Center for Comprehensive Care | Seattle, Washington | USA |
| Temple University Hospital | Philadelphia, Pennsylvania | USA |
| The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange, California | USA |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| The Liver Institute of Methodist Dallas Medical Center | Dallas, Texas | USA |
| The Miriam Hospital | Providence, Rhode Island | USA |
| The University of Michigan Hospitals and Health Systems | Ann Arbor, Michigan | USA |
| Tokyo Metropolitan Bokutoh Hospital | Tokyo | Japan |
| Tufts Medical Center | Boston, Massachusetts | USA |
| Tulane University | New Orleans, Louisiana | USA |
| Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie | Düsseldorf | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| University College London | London | United-Kingdom |
| University Hospitals Cleveland Medical Center | Cleveland, Ohio | USA |
| University of Chicago | Chicago, Illinois | USA |
| University of Colorado Denver, University of Colorado Hospital | Aurora, Colorado | USA |
| University of Iowa Hospitals & Clinics | Iowa City, Iowa | USA |
| University of Utah Health | Salt Lake City, Utah | USA |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | Germany |
| Universitätsspital Zürich | Zürich | Switzerland |
| UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy |
| UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S. | Roma | Italy |
| UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova | Padova PD | Italy |
| UOC Malattie Infettive, ASST Papa Giovanni XXIII | Bergamo | Italy |
| UOC Malattie Infettive, IRCCS Ospedale San Raffaele | Milano | Italy |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic | Dallas, Texas | USA |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd. | Dallas, Texas | USA |
| UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd | Dallas, Texas | USA |
| VCU Health Medical Center | Richmond, Virginia | USA |
| Virginia Hospital Center | Arlington, Virginia | USA |
| Virginia Mason Medical Center | Seattle, Washington | USA |
| Weill Cornell Medical College/NYU Presbyterian Hospital | New York, New York | USA |
| Yale University | New Haven, Connecticut | USA |
| Yokohama Municipal Citizen's Hospital | Kanagawa | Japan |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 02 Dec 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 02 Dec 2022 |
| 06 Jul 2022 | Other trial event | Last checked against Japan Pharmaceutical Information Center - Clinical Trials Information record. Updated 06 Jul 2022 |
| 12 Jan 2022 | Other trial event | Last checked against European Clinical Trials Database record. Updated 12 Jan 2022 |
| 16 Dec 2021 | Other trial event | New source identified and integrated(Japan Pharmaceutical Information Center - Clinical Trials Information:JapicCTI205256 ). Updated 16 Dec 2021 |
| 17 Nov 2020 | Results | Results of post-hoc analysis assessing safety and clinical outcomes in moderate COVID-19 patients with or without elevated baseline alanine aminotransferase levels, presented at The Liver Meeting 2020 70th Annual Meeting of the American Association for the Study of Liver Diseases. Updated 28 Jan 2021 |
| 25 Oct 2020 | Results | Results presented at the IDWeek 2020 Updated 17 Dec 2020 |
| 25 Oct 2020 | Results | Results (n=584) assessing baseline characteristics associated with clinical improvement at day 14, presented at the IDWeek 2020 Updated 16 Dec 2020 |
| 28 Aug 2020 | Other trial event | According to a Gilead Sciences media release, based on the SIMPLE-moderate (Study GS-US-540-5774) and ACTT-1 studies, the USA Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. Updated 02 Sep 2020 |
| 12 Aug 2020 | Endpoint met | Primary endpoint (The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 (5 days randomized)) has been met according to results published in the JAMA: the Journal of the American Medical Association. Updated 10 Sep 2020 |
| 12 Aug 2020 | Endpoint not met | Primary endpoint (The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 (10 days randomized)) has not been met according to results published in the JAMA: the Journal of the American Medical Association. Updated 10 Sep 2020 |
| 12 Aug 2020 | Results | Results published in the JAMA: the Journal of the American Medical Association Updated 26 Aug 2020 |
| 23 Jul 2020 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 28 Jul 2020 |
| 20 Jul 2020 | Other trial event | This trial has been completed in France according to European Clinical Trials Database (global end of the trial 2020-06-26) Updated 20 Jul 2020 |
| 14 Jul 2020 | Other trial event | This trial has been completed in Spain, according to European Clinical Trials Database. Updated 14 Jul 2020 |
| 03 Jul 2020 | Other trial event | This trial has been completed in Sweden, according to European Clinical Trials Database. Updated 03 Jul 2020 |
| 01 Jun 2020 | Results | Results presented in the Gilead Sciences Media Release. Updated 04 Jun 2020 |
| 29 May 2020 | Completion date | Planned End Date changed from 1 May 2020 to 1 Jun 2020. Updated 03 Jun 2020 |
| 29 May 2020 | Other trial event | Planned primary completion date changed from 1 May 2020 to 1 Jun 2020. Updated 03 Jun 2020 |
| 29 May 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 03 Jun 2020 |
| 29 Apr 2020 | Other trial event | According to an Gilead Sciences media release, the results from the first 600 patients of this study are expected at the end of May. Updated 04 May 2020 |
| 10 Apr 2020 | Other trial event | According to an Gilead Sciences media release, data from this study is expected in May 2020. Updated 16 Apr 2020 |
| 27 Mar 2020 | Other trial event | Planned number of patients changed from 600 to 1600. Updated 27 Mar 2020 |
| 20 Mar 2020 | Other trial event | According to a University Hospitals media release, this study will be conducted by the UH Clinical Research Center, under the leadership of Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at UH. Updated 26 Mar 2020 |
| 20 Mar 2020 | Other trial event | According to a University Hospitals media release, the UH is hoping to open the trial at UH Ahuja, Parma and St. John medical centers. Updated 26 Mar 2020 |
| 20 Mar 2020 | Other trial event | According to a University Hospitals media release, this trial is approved by the U.S. Food and Drug Administration (FDA) and UH Institutional Review Board and are expecting shipment of the experimental drug remdesivir in the next couple of days. Updated 26 Mar 2020 |
| 20 Mar 2020 | Other trial event | According to the Feinstein Institute for Medical Research media release, the lead investigator on this study is Prashant Malhotra, MD, assistant professor in the Institute of Health Innovations & Outcomes Research at Feinstein, and an infectious disease expert. Updated 23 Mar 2020 |
| 15 Mar 2020 | Protocol amendment | The protocol was amended on March 15, 2020, on the basis of emerging understanding of the clinical presentation and assessment of COVID-19. The age limit for eligibility was lowered from 18 years to 12 years and the minimum temperature requirement was eliminated and primary objective changed from efficacy with respect to the proportion of participants discharged on or before Day 14 to efficacy with respect to clinical status assessed by a 7-point ordinal scale Day11 and number of sites expanded. Updated 10 Sep 2020 |
| 13 Mar 2020 | Other trial event | New source identified and integrated (European Clinical Trials Database: EudraCT2020-000842-32). Updated 13 Mar 2020 |
| 13 Mar 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 13 Mar 2020 |
| 05 Mar 2020 | Other trial event | New source identified and integrated (ClinicalTrial.gov: NCT04292730) Updated 05 Mar 2020 |
| 02 Mar 2020 | New trial record | New trial record Updated 02 Mar 2020 |
| 28 Feb 2020 | Status change - not yet recruiting | Status changed from planning to not yet recruiting. Updated 05 Mar 2020 |
| 26 Feb 2020 | Other trial event | According to a Gilead scineces media release, U.S. FDA Grants Investigational New Drug Authorization for this study. This study is anticipated to begin in March. Updated 02 Mar 2020 |
| 26 Feb 2020 | Other trial event | According to a Gilead scineces media release, this trial is led by China-Japan Friendship Hospital in China. Updated 02 Mar 2020 |
Table of Contents
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