Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Trial Profile

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2020

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms SIMPLE; SIMPLE-severe
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 29 May 2020 Planned End Date changed from 1 May 2020 to 1 Jun 2020.
    • 29 May 2020 Planned primary completion date changed from 1 May 2020 to 1 Jun 2020.
    • 29 May 2020 Status changed from recruiting to active, no longer recruiting.

Trial Overview

Purpose

This phase III study is designed to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).

Comments

According to an Emalex Biosciences media release, EMA's human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated. The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19.EMA is currently evaluating these data in the context of the rolling review of remdesivir.In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).A treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from this study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy.Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir.Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation (as of 11th May 2020).

The Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States. The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases's global Phase 3 trial, the company's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from company's compassionate use program, including patients in Japan.
According to a Gilead Sciences media release, the U.S. FDA granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease.The EUA is based on available data from two global clinical trials, the National Institute for Allergy and Infectious Diseases placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 (NCT04280705), including those who were critically ill, and Gileads global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease (NCT04292899).The EUA is temporary and does not take the place of the formal new drug application submission, review and approval process. The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19, remdesivir remains an investigational drug and has not been approved by FDA.

Primary Endpoints

The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 14

[ Time Frame: Day 14 ]
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 any Treatment-Emergent Adverse Events

time_frame: First dose date up to 10 days plus 30 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 6000

  • Sex male & female
  • Age Group ≥ 12 years; adolescent; adult; child; elderly

Patient Inclusion Criteria

Key - Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures - Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC)) - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization - Currently hospitalized - Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening Key

Patient Exclusion Criteria

- Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing - Evidence of multiorgan failure - Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO. - 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
NCT04292899 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-000841-15 European Clinical Trials Database
GS-US540-5773 Gilead Sciences

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Planned : 01 Mar 2020

    Actual : 06 Mar 2020

  • Primary Completion Dates

    Planned : 01 Jun 2020

  • End Dates

    Planned : 01 Jun 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location China; England; France; Germany; Hong Kong; 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

Part A: Remdesivir (RDV), 5 Days (Not Mechanically Ventilated)

Participants who are not mechanically ventilated 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™
Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part A: Remdesivir, 10 Days (Not Mechanically Ventilated)

Participants who are not mechanically ventilated 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™
Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part B: Remdesivir 10 days (Mechanically Ventilated)

Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™
Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part B: Remdesivir, 5 or 10 Days (Extension)

Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™
Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Results

Therapeutic efficacy

Treatment with remdesivir in a phase III SIMPLE trial for COVID-2019 infections showed that the time to clinical improvement for 50% patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. Greater than 2-point improvement in ordinal scale was seen in 65% and 54% patients for 5 and 10 day treatment respectively. More than half of patients in both treatment groups were discharged from the hospital by day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At day 14, 64.5% patients in the 5-day treatment group and 53.8% of patients in the 10-day treatment group achieved clinical recovery. Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at day 14 was 7% across both treatment groups, with 64% of patients experiencing clinical improvement at day 14 and 61 percent (n=196/320) of patients discharged from the hospital. In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by day 14, 62% patients treated early were able to be discharged from the hospital, compared with 49% patients who were treated late [2] .

Adverse events

Treatment with remdesivir in a phase III SIMPLE trial for COVID-2019 infections showed that the drug was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events (AE) occurring in more than 10% of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3% of patients, with 3% of patients discontinuing remdesivir treatment due to elevated liver tests. Study drug-related serious adverse event were observed in 2% patients in both groups. AE leading to discontinuation were observed in 5% and 10% patients in 5 day and 10 day groups respectively [2] .

Publications

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

    Media Release
  2. Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, et al. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Ahn MY 1 - -
Blair C 1 - -
Brainard DM 1 - -
Bruno R 1 - -
Cao H 1 - -
Chen YS 1 - -
Diaz G 1 - -
Gaggar A 1 - -
Galli M 1 - -
Gilead Sciences 1 1 1
Goldman JD 1 1 -
Hui DS 1 - -
Hyland RH 1 - -
Lye DCB 1 - -
Marks KM 1 - -
Marty FM 1 - -
Montejano R 1 - -
Mullane KM 1 - -
Munoz J 1 - -
Nahass RG 1 - -
Osinusi AO 1 - -
SenGupta D 1 - -
Spinner CD 1 - -
Subramanian A 1 - 1
Tashima KT 1 - -
Towner WJ 1 - -
Wei X 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
-
Icahn School of Medicine at Mount Sinai, Icahn School of Medicine at Mount Sinai, 1000 10th Avenue, Icahn School of Medicine at Mount Sinai, 350 East 17th Street, Icahn School of Medicine at Mount Sinai, 440 West 114th St. USA
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
show details
, Gilead Sciences
-
Gilead Study Director Gilead Sciences
-

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
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
Beth Israel Deaconess Medical Center Boston, Massachusetts 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
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 Medical Center-New York Presbyterian Hospital New York, New York USA
Complejo Hospitalario Universitario A Coruña A Coruña Spain
Danbury Hospital Lagrangeville, New York USA
Darmouth-Hitchhock Medical Center Lebanon, New Hampshire USA
Derriford Hospital Plymouth United-Kingdom
Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco Milano Italy
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
-
-
Hackensack University 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 Vall d'Hebron Barcelona 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 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 Healthcare NHS Trust London, Greater London United-Kingdom
Inova Fairfax Medical Campus 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
John H. Stroger Jr. Hospital of Cook County Chicago, Illinois 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 Los Angeles, California USA
Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street Panorama City, 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, 27300 Iris Avenue Moreno Valley, 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 Oakland Medical Center Oakland, California USA
Kaiser Permanente Oakland Medical Center, 1200 El Camino Real 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 Permanente-Oakland, 2425 Geary Blvd San Francisco, 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
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
New York Presbyterian Hospital/Weill Cornell Medical Center New York, New York USA
North Shore University Hospital Manhasset, New York USA
North Shore University Hospital, 270-05 76th Ave Manhasset, 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 Portland Medical Center Portland, Oregon USA
Providence Regional Medical Center Everett Everett, Washington 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 Infirmary of Edinburgh Edinburgh 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 I, Fondazione IRCCS Policlinio San Matteo Pavia Italy
UOC Malattie Infettive, ASST Papa Giovanni XXIII Bergamo Italy
UOC Malattie Infettive, IRCCS Ospedale San Raffaele Milano Italy
UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova Padova PD 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
Yale-New Haven Hospital New Haven, Connecticut USA
Yokohama Municipal Citizen's Hospital Kanagawa Japan

Trial History

Event Date Event Type Comment
03 Jun 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 03 Jun 2020
01 Jun 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 01 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
27 May 2020 Results Results (N=397), comparing efficacy of Remdesivir for 5 or 10 days in patients with severe Covid-19 infections, published in the New England Journal of Medicine Updated 01 Jun 2020
22 May 2020 Other trial event According to an Gilead Sciences media release, results from our Phase 3 SIMPLE-Severe study, which is evaluating remdesivir in a similar population of COVID-19 patients requiring oxygen but not on mechanical ventilation, will be published in the near future. These data from the SIMPLE-Severe study support treatment of some patients for 5 days rather than 10 days, depending on clinical status. Updated 29 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from this study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, in addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation). Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, the updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19.EMA is currently evaluating these data in the context of the rolling review of remdesivir. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, EMAs human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated. Updated 18 May 2020
07 May 2020 Other trial event According to an Gilead Sciences media release, the Japanese Ministry of Health, Labour and Welfare (MHLW) approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases's global Phase 3 trial, the company's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from company's compassionate use program, including patients in Japan. Updated 12 May 2020
07 May 2020 Other trial event According to an Gilead Sciences media release, the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States. Updated 12 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the EUA is temporary and does not take the place of the formal new drug application submission, review and approval process. The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19, remdesivir remains an investigational drug and has not been approved by FDA. Updated 08 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the EUA is based on available data from two global clinical trials, the National Institute for Allergy and Infectious Diseases placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 (NCT04280705), including those who were critically ill, and Gileads global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease (NCT04292899). Updated 08 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the U.S. FDA has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. Updated 08 May 2020
29 Apr 2020 Other trial event According to an Gilead Sciences media release, Gilead will share additional remdesivir data from this trial with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Updated 04 May 2020
29 Apr 2020 Results Results published in Gilead Sciences Media Release Updated 04 May 2020
16 Apr 2020 Other trial event Planned number of patients changed from 2400 to 6000. Updated 20 Apr 2020
10 Apr 2020 Other trial event According to an Gilead Sciences media release, data from this study is expected in April 2020(this month). Updated 16 Apr 2020
30 Mar 2020 Other trial event Planned number of patients changed from 400 to 2400. Updated 30 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 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 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 the Feinstein Institute for Medical Research media release, the lead investigator on this study is Marcia Epstein, MD, Feinstein Institutes researcher and an infectious disease expert. Updated 23 Mar 2020
15 Mar 2020 Protocol amendment The lower age limit for eligibility was reduced from 18 years to 12 years, and a requirement for an axillary temperature of at least 36.6 degree Celsius at screening was eliminated. In addition, one of the primary efficacy assessments the proportions of patients with normalization of temperature at day 14 was changed to assessment of clinical status on a 7 point ordinal scale on day 14. Also amended to add an extension phase involving an additional 5600 patients Updated 01 Jun 2020
13 Mar 2020 Other trial event New source identified and integrated(European Clinical Trials Database;EudraCT2020-000841-15). Updated 13 Mar 2020
10 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 16 Mar 2020
06 Mar 2020 Other trial event New source identified and integrated (ClinicalTrials.gov record; NCT04292899) Updated 06 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 06 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
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

References

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

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

    Media Release
  3. Gilead Sciences. Gileads Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of 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. Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, et al. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  7. Emalex Biosciences. EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation. Media-Rel 2020;.

    Media Release
  8. Gilead Sciences. Gilead Sciences Statement on NEJM Publication of Remdesivir Data From NIAID Study. Media-Rel 2020;.

    Media Release
  9. Gilead Sciences. Gilead Announces Approval of Veklury(Rm) (remdesivir) in Japan for Patients With Severe COVID-19. Media-Rel 2020;.

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

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

    Media Release
  12. 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
  13. Gilead Sciences. Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases Study of Investigational Antiviral Remdesivir for COVID-19. Media-Rel 2020;.

    Media Release
Back to top