AzTrials
AzTrials

COVID-19Phase 3NCT04292730

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

A Phase 3 study testing Remdesivir in people with COVID-19, run by Gilead Sciences at 184 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
COVID-19
What is being tested?
Remdesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,113 participants
Where
184 sitesin 15 countries
Study dates
15 Mar 2020to 26 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

184 sites in 15 countries.

184 sites in 15 countries

United States106 sites

  • Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

    Anaheim, California, 92806

  • The University of Michigan Hospitals and Health Systems

    Ann Arbor, Michigan, 48109-5378

  • Virginia Hospital Center

    Arlington, Virginia, 22205

  • University of Colorado Denver, University of Colorado Hospital

    Aurora, Colorado, 80045

  • Alta Bates Summit Medical Center

    Berkeley, California, 94609

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham & Women's Hospital and Harvard Medical School

    Boston, Massachusetts, 02115

  • Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Eden Medical Center

    Castro Valley, California, 94546

  • Cook County General Hospital

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

  • The Liver Institute of Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

    Dallas, Texas, 75390

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

    Dallas, Texas, 75390

  • SCL Health St. Joseph Hospital, 1375 East 19th Ave

    Denver, Colorado, 80208

  • SCL Health St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

    Downey, California, 90241

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Medical Research Center

    Everett, Washington, 98201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

    Fontana, California, 92335

  • Baylor University Medical Center, 1400 8th Ave

    Fort Worth, Texas, 76104

  • St Joseph Hospital Eureka

    Fortuna, California, 95540

  • Prisma Health Richland Hospital, 701 Grove Road

    Greenville, South Carolina, 29605

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601

  • Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

    Harbor City, California, 90710

  • Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

    Hillsboro, Oregon, 97124

  • Robert Wood Johnson University Hospital Somerset

    Hillsborough, New Jersey, 08844

  • Kaiser Permanente Hawaii Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46077

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Kadlec Regional Medical Center

    Kennewick, Washington, 99336

  • SCL Health St. Joseph Hospital, 200 Exempla Circle.

    Lafayette, Colorado, 80026

  • Danbury Hospital

    Lagrangeville, New York, 12540

  • Darmouth-Hitchhock Medical Center

    Lebanon, New Hampshire, 03756

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

    Los Angeles, California, 90034

  • Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

    Los Angeles, California, 91365

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Hennepin Healthcare

    Minneapolis, Minnesota, 55415

  • Mission Hospital Regional Medical Center

    Mission Viejo, California, 92691

  • Providence St Patrick Hospital and International Heart Institute of MT Foundation

    Missoula, Montana, 59802

  • Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue

    Moreno Valley, California, 92555

  • El Camino Hospital

    Mountain View, California, 94040

  • Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

    New Brunswick, New Jersey, 08901

  • Yale University

    New Haven, Connecticut, 06510

  • North Shore University Hospital, 270-05 76th Ave

    New Hyde Park, New York, 11040

  • Tulane University

    New Orleans, Louisiana, 70112

  • Icahn School of Medicine at Mount Sinai, 350 East 17th Street

    New York, New York, 10003

  • Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

    New York, New York, 10019

  • Icahn School of Medicine at Mount Sinai, 440 West 114th St.

    New York, New York, 10025

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Weill Cornell Medical College/NYU Presbyterian Hospital

    New York, New York, 10065

  • Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

    Newark, New Jersey, 07112

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Providence St. Peter Hospital

    Olympia, Washington, 98506

  • Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

    Ontario, California, 91761

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • Kaiser Permanente Los Angeles Medical Center,13651 Willard Street

    Panorama City, California, 91402

  • St. Joseph's University Medical Center

    Paterson, New Jersey, 07503

  • Hospital of the University of Pennsylvania, 51 N. 31st Street

    Philadelphia, Pennsylvania, 19104

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Sunnyside Medical Center

    Portland, Oregon, 97227

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • VCU Health Medical Center

    Richmond, Virginia, 23298

  • Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

    Riverside, California, 92505

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Medical Center Sacramento, One Medical Plaza

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95815

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

    San Diego, California, 92120-2507

  • Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

    San Diego, California, 92123

  • Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

    San Francisco, California, 94080

  • California Pacific Medical Center-Infectious Disease Associates Medical Group

    San Francisco, California, 94109

  • Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

    San Francisco, California, 94115

  • Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

    San Jose, California, 95119

  • Kaiser Permanente Oakland Medical Center, 2500 Merced St

    San Leandro, California, 94577

  • Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

    Santa Clara, California, 95051

  • Providence St. Johns Medical Center

    Santa Monica, California, 90404

  • Sutter Santa Rosa Regional Hospital

    Santa Rosa, California, 95403

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Center for Comprehensive Care

    Seattle, Washington, 98104

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • MultiCare Deaconess Hospital

    Spokane, Washington, 99204

  • Stanford Hospital

    Stanford, California, 94305

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • St Joseph Medical Center

    Tacoma, Washington, 98405

  • Baylor University Medical Center, 2401 S. 31st St.

    Temple, Texas, 76508

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • James J. Peters Veterans Administration Medical Center

    The Bronx, New York, 10468

Other trials in United States

United Kingdom15 sites

  • NHS Lothian, Royal lnfirmary of Edinburgh

    Edinburgh, EH4 2XU

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU16 5JQ

  • Royal Lancaster Hospital

    Lancaster, LA1 4RP

  • Liverpool University Hospital

    Liverpool, L7 8XP

  • Imperial College NHS Trust

    London, Greater London, W2 1NY

  • Northwick Park Hospital

    London, HA1 3UJ

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College Hospital NHS Trust

    London, SE5 9RS

  • University College London

    London, WC1E 6JF

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT

  • Pennine Acute Hospitals NHS Trust

    Manchester, M8 5RB

  • Derriford Hospital

    Plymouth, PL6 8BG

  • Sheffield Teaching Hospitals

    Sheffield, S10 2JF

Other trials in United Kingdom

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Cruces

    Bizkaia, 48903

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Italy12 sites

  • UOC Malattie Infettive, ASST Papa Giovanni XXIII

    Bergamo, 24127

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • ASST di Cremona - Azienda Socio Sanitaria Territor

    Cremona, 26100

  • UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • UOC Malattie Infettive, IRCCS Ospedale San Raffaele

    Milan, 20127

  • ASST Fatebenefratelli Sacco

    Milan, 20157

  • UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova

    Padova PD, 35121

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ospedale Guglielmo da Saliceto AUSL di Piacenza

    Piacenza

  • UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

    Roma, 00149

  • Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

    Torino, 10149

Other trials in Italy

Germany8 sites

  • Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

    Berlin, 13353

  • Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

    Düsseldorf, 40225

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

    Leipzig, 4129

  • Klinik für Hämatologie, Onkologie, Immunologie

    München, 80804

  • Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

    Munich, 81675

  • Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

    Stuttgart, 70376

Other trials in Germany

France5 sites

  • CHU Pellegrin

    Bordeaux, 33076

  • CHU de Montpellier-Hopital Gui de Chauliac

    Montpelier Cedex 5, 34295

  • CHU de Nantes-Hotel Dieu

    Nantes, 44035

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

Other trials in France

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Japan3 sites

  • Yokohama Municipal Citizen's Hospital

    Kanagawa, 240-8555

  • Nagoya City East Medical Center

    Nagoya, 464-8547

  • Tokyo Metropolitan Bokutoh Hospital

    Tokyo, 130-8575

Other trials in Japan

Netherlands3 sites

  • Amsterdam University Medical Centre - Location AMC

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Erasmus Medical Centre

    Rotterdam, 3015 GD

Other trials in Netherlands

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169856

  • National Centre for Infectious Diseases, Tan Tock Seng Hospital

    Singapore, 308442

Other trials in Singapore

South Korea3 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Seoul Medical Center

    Seoul, 02053

  • National Medical Center

    Seoul, 04564

Other trials in South Korea

Sweden3 sites

  • Sahlgrenska University Hospital, Ostra

    Gothenburg, 41685

  • SUS (Skanes University Hospital)

    Malmö, 20502

  • Karolinska University Hospital

    Stockholm, SE-141 86

Other trials in Sweden

Switzerland3 sites

  • Hopitaux Universitaires de Genève

    Geneva, 1211

  • Ospedale Regionale di Locarno La Carità

    Lugano, CH- 6900

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Taiwan3 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

China1 site

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

Other trials in China

About this study

Official title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

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.

Conditions
COVID-19
Being tested
Remdesivir, Standard of Care
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemdesivirDrug

    Also called GS-5734™, Veklury®

    Administered as an intravenous infusion

  • Standard of CareDrug

    Standard of Care Treatment for COVID-19 Infection

Study groups in NCT04292730
Study groupRoleWhat they receive
Part A: Remdesivir (RDV), 5 DaysExperimentalParticipants 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.
Receives: Drug: Remdesivir; Drug: Standard of Care
Part A: Remdesivir, 10 DaysExperimentalParticipants 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.
Receives: Drug: Remdesivir; Drug: Standard of Care
Part A: SOC TherapyActive comparatorParticipants will receive continued standard of care therapy.
Receives: Drug: Standard of Care
Part B: Extension Treatment, Remdesivir 10 DaysExperimentalParticipants 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.
Receives: Drug: Remdesivir; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11

    Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.

    Measured: Day 11

Secondary outcomes (1)

  1. Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

    TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.

    Measured: First dose date up to last dose date (maximum: 10 days) plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start15 Mar 2020
  3. Primary completion29 Apr 2020
  4. Study completion26 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292730
Sponsor's protocol ID
GS-US-540-5774
Other IDs
2020-000842-32, ISRCTN85762140
Status last verified
Jan 2021
First submitted
28 Feb 2020
Last updated
26 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Expanded access
Available

Publications

  • Spinner CD, Gottlieb RL, Criner GJ, Arribas Lopez JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349.

    PubMed 32821939

  • Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

    PubMed 36695483

  • Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.

    PubMed 34350582

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remdesivir in people with COVID-19, run by Gilead Sciences at 184 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, United Kingdom, Spain, Italy, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 (time frame: Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292730, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in