COVID-19Phase 3REDPINENCT04745351
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
A Phase 3 study testing Remdesivir in people with COVID-19, run by Gilead Sciences at 63 sites in 6 countries.
Trial summary
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19). 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?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 63 sitesin 6 countries
- Study dates
- 31 Mar 2021to 24 May 2022
- 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
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen
- Hospitalized for COVID-19
- Weighing at least 40 kilograms (kg)
- Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
- Have either:
- a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis
- b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
- The interval between COVID-19 symptoms onset and randomization is no more than 10 days
Who cannot join
- Received any investigational drug, RDV, or other antiviral treatment for COVID-19
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal
- Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)
- Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
- Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
63 sites in 6 countries.
63 sites in 6 countries
United States41 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
Wake Forest University Health Sciences
Bethesda, Maryland, 20892
St. Vincent's Health System
Birmingham, Alabama, 35205
UAB Hospital
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 92037
St. Joseph Hospital Eureka
Eureka, California, 95501
Providence Regional Medical Center Everett
Everett, Washington, 98201
North Florida/ South Georgia Veterans Health System
Gainesville, Florida, 32608
Holy Cross Hospital, 19801 Observation Dr
Germantown, Maryland, 20876
St. Clair Nephrology Research
Grosse Pointe Woods, Michigan, 48236
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann Hospital at TMC
Houston, Texas, 77030
Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave
Irvine, California, 92618
G.V. (Sonny) Montgomery VAMC
Jackson, Michigan, 39216
Mayo Clinic Florida
Jacksonville, Florida, 32224
Baptist Health Lexington
Lexington, Kentucky, 40503
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 36608
Tulane Medical Center, 2000 Canal St.
New Orleans, Louisiana, 70112
Tulane Medical Center
New Orleans, Louisiana, 70112
New York - Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
Saint Michael's Medical Center
Newark, New Jersey, 07102
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Temple University Hospital
Philadelphia, Pennsylvania, 19140
PMG Infectious Disease Consultants (administrative)
Portland, Oregon, 92775
VCU Health Medical Center
Richmond, Virginia, 23298
Mayo Clinic Hospital
Rochester, Minnesota, 55902
Sutter Medical Center Sacramento
Sacramento, California, 95816
Swedish Medical Center
Seattle, Washington, 98122
Holy Cross Hospital
Silver Spring, Maryland, 20910
Providence Health Care
Spokane, Washington, 99204
Providence Health Care, 5633 N Lidgerwood
Spokane, Washington, 99208
Stony Brook University Hospital
Stony Brook, New York, 11716
MultiCare Good Samaritan Hospital
Tacoma, Washington, 98405
Genesis Clinical Research
Tampa, Florida, 33603
Jacobi Medical Center
The Bronx, New York, 10461
Torrance Memorial Medical Center
Torrance, California, 90505
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Spain8 sites
Hospital Universitario Germans Trias I Pujol
Badalona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Clinic de Barcelona
Barcelona, 8036
Hospital General Universitario de Elche
Elche, 3203
Hospital Universitario 12 de Octubre
Madrid, 28041
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007
Hospital General Universitario de Valencia
Valencia, 46014
Portugal5 sites
Centro Hospitalar Cova da Beira EPE
Covilha, 6200-251
Hospital Nélio Mendonça,
Funchal, 9000-514
Centro Hospitalar Lisboa Ocidental
Lisbon, 1449-005
Centro Hospitalar do Porto - Hospital de Santo Antonio
Odivelas, 2620-144
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4434-502
Brazil4 sites
Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas
Campinas, 13060-904
Hospital Nossa Senhora das Gracas
Curitiba, 80810-040
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-020
United Kingdom3 sites
Barts Health NHS Trust, The Royal London Hospital
London, E1 1BB
Kings College Hospital
London, SE5 9RS
Imperial College Healthcare NHS Trust
London, W12 0HS
South Africa2 sites
George Regional Hospital
George, 6529
Mediclinic Vergelegen
Somerset West, 7130
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
- Conditions
- COVID-19
- Being tested
- Remdesivir, RDV Placebo, 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 Intravenous (IV) infusion once daily
RDV PlaceboDrug
Administered as IV saline once daily
Standard of CareDrug
Standard of Care Treatment for COVID-19 Infection
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir (RDV) | Experimental | Participants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5. Receives: Drug: Remdesivir; Drug: Standard of Care |
| Placebo | Placebo comparator | Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5. Receives: Drug: RDV Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Measured: First dose date up to Day 29
Secondary outcomes (11)
All-cause Mortality Through Day 29
The reported percentage was from the Kaplan-Meier estimate.
Measured: First dose date up to Day 29
Percentage of Participants With Initiation of IMV Through Day 29
The reported percentage was the cumulative-incidence estimate.
Measured: First dose date up to Day 29
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Measured: First dose date up to Day 29
Time to Recovery Independent of Further Worsening by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Measured: First dose date up to Day 29
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Measured: Day 15
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Measured: Day 29
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Measured: First dose date up to Day 29
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Measured: First dose date up to Day 29
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Measured: First dose date up to Day 29
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Measured: First dose date up to last dose date (Maximum: 5 days) plus 30 days
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.
Measured: First dose date up to last dose date (Maximum: 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start31 Mar 2021
- Primary completion20 Apr 2022
- Study completion24 May 2022
Why it stopped: The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745351
- Sponsor's protocol ID
- GS-US-540-5912
- Other IDs
- 2020-005416-22, DOH-27-012022-4779
- Acronym
- REDPINE
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2021
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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.gileadclinicaltrials.com/transparency-policy/
- Expanded access
- Available
Publications
Rodriguez L, Andreatta K, Chen S, Hu Y, Li J, Martin R, Han D, Moshiri J, Perry JK, Sise ME, Santos JR, Plate M, McPhail MJ, Koullias Y, Hyland RH, Hedskog C. Virologic insights from the phase 3 REDPINE trial: remdesivir in renally impaired and immunocompromised patients with COVID-19. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0191225. doi: 10.1128/aac.01912-25. Epub 2026 Jul 10.
PubMed 42429789Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333.
PubMed 38913574Grundeis 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
- ClinicalTrials.gov ID
- NCT04745351
- Acronym / sponsor ID
- REDPINE / GS-US-540-5912
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir (RDV) | Experimental | Drug: Remdesivir, Drug: Standard of CareParticipants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5. |
| Placebo | Placebo comparator | Drug: RDV Placebo, Drug: Standard of CareParticipants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen
- Hospitalized for COVID-19
- Weighing at least 40 kilograms (kg)
- Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
- Have either:
Key exclusion criteria (6 listed)
- Received any investigational drug, RDV, or other antiviral treatment for COVID-19
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal
- Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)
- Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
- Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirAlso: GS-5734™, Veklury®Administered as Intravenous (IV) infusion once daily | Drug | Remdesivir (RDV) |
| RDV PlaceboAdministered as IV saline once daily | Drug | Placebo |
| Standard of CareStandard of Care Treatment for COVID-19 Infection | Drug | Placebo, Remdesivir (RDV) |
Primary outcome
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
Time frame: First dose date up to Day 29
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
11 secondary outcomes
All-cause Mortality Through Day 29
Time frame: First dose date up to Day 29
Percentage of Participants With Initiation of IMV Through Day 29
Time frame: First dose date up to Day 29
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Time frame: First dose date up to Day 29
Time to Recovery Independent of Further Worsening by Day 29
Time frame: First dose date up to Day 29
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Time frame: Day 15
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Time frame: Day 29
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
Time frame: First dose date up to Day 29
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Time frame: First dose date up to Day 29
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Time frame: First dose date up to Day 29
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose date up to last dose date (Maximum: 5 days) plus 30 days
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
Time frame: First dose date up to last dose date (Maximum: 5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42429789Rodriguez L, Andreatta K, Chen S, Hu Y, Li J, Martin R, Han D, Moshiri J, Perry JK, Sise ME, Santos JR, Plate M, McPhail MJ, Koullias Y, Hyland RH, Hedskog C. Virologic insights from the phase 3 REDPINE trial: remdesivir in renally impaired and immunocompromised patients with COVID-19. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0191225. doi: 10.1128/aac.01912-25. Epub 2026 Jul 10.
- Derived from this study: PubMed 38913574Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333.
- Derived from this study: PubMed 36695483Grundeis 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.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
63 sites in 6 countries: see every site and its status.
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 63 sites in 6 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 8 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: stopped early, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Spain, Portugal, Brazil, United Kingdom and 1 more country. 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. Some participants in this study may receive a placebo. 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 12 May 2023). 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?
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29 (time frame: First dose date up to Day 29). 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 NCT04745351, 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 12 May 2023.