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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Aug 2020

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms SIMPLE; SIMPLE-moderate
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 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.
    • 12 Aug 2020 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.
    • 12 Aug 2020 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.

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

The primary objective of this study is 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

Met on 12 Aug 2020

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]

Not met, 12 Aug 2020

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

Proportion of Participants experiencing Treatment-Emergent Adverse Events

time_frame: First dose date up to 10 days plus 30 days [2]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
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

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

  • 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; France; Germany; Hong Kong; Iran; Italy; Japan; Netherlands; 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 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 5 or 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: Continued 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 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

  1. 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
  2. Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Ahn MY 1 - -
Arribas Lopez JR 1 - -
Bernasconi E 1 - -
Bhagani S 1 - -
Blair C 1 - -
Brainard DM 1 - -
Cao H 1 - -
Castagna A 1 - -
Cattelan AM 1 - -
Chai LYA 1 - -
Chang SC 1 - -
Criner GJ 1 - -
Gaggar A 1 - -
Gilead Sciences 1 1 1
Gottlieb RL 1 - -
Huhn G 1 - -
Hyland RH 1 - -
Le Turnier P 1 - -
Malhotra P 1 - -
Marty FM 1 - 1
McPhail MJ 1 - -
Mullane KM 1 - -
Ogbuagu O 1 - -
Osinusi AO 1 - -
Roestenberg M 1 - -
Sanyal AJ 1 - -
SenGupta D 1 - -
Soriano Viladomiu A 1 - -
Spinner CD 1 1 -
Tsang OTY 1 - -
Wang H 1 - -

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
show details
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
-
-
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
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
28 Jul 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 28 Jul 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
20 Jul 2020 Other trial event Last checked against European Clinical Trials Database record. 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

References

  1. 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
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19. Media-Rel 2020;.

    Media Release
  4. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  5. The Feinstein Institute for Medical Research. Feinstein Institutes begins enrolling patients in multiple COVID-19 clinical trials. Media-Rel 2020;.

    Media Release
  6. Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Media-Rel 2020;.

    Media Release
  7. Gilead Sciences. Gileads Investigational Antiviral Veklury(R)(Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19. Media-Rel 2020;.

    Media Release
  8. University Hospitals. University Hospitals among first in nation to test investigational antiviral drug against COVID-19. Media-Rel 2020;.

    Media Release
  9. Gilead Sciences. Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  10. Gilead Sciences. Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine. Media-Rel 2020;.

    Media Release
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