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)

NCT04745351 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-540-59122020-005416-22DOH-27-012022-4779
• Study Type: interventional
• Target: 249
• Locations: 6 countries
• Sites: 63

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  First dose date up to Day 29

Secondary Outcomes (11)

• All-cause Mortality Through Day 29

  First dose date up to Day 29

• Percentage of Participants With Initiation of IMV Through Day 29

  First dose date up to Day 29

• Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29

  First dose date up to Day 29

• Time to Recovery Independent of Further Worsening by Day 29

  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

  Day 15

Study Arms (2)

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.

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.

Drug: RDV Placebo; Drug: Standard of Care

Interventions

Remdesivir DRUG

Administered as Intravenous (IV) infusion once daily

Also known as: GS-5734™, Veklury®

Remdesivir (RDV)

RDV Placebo DRUG

Administered as IV saline once daily

Placebo

Standard of Care DRUG

Standard of Care Treatment for COVID-19 Infection

Placebo; Remdesivir (RDV)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (63)

St. Vincent's Health System

Birmingham, Alabama, 35205, United States

Location

UAB Hospital

Birmingham, Alabama, 35294, United States

Location

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, 36608, United States

Location

St. Joseph Hospital Eureka

Eureka, California, 95501, United States

Location

Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave

Irvine, California, 92618, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

North Florida/ South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Tulane Medical Center, 2000 Canal St.

New Orleans, Louisiana, 70112, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Wake Forest University Health Sciences

Bethesda, Maryland, 20892, United States

Location

Holy Cross Hospital, 19801 Observation Dr

Germantown, Maryland, 20876, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20910, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

St. Clair Nephrology Research

Grosse Pointe Woods, Michigan, 48236, United States

Location

G.V. (Sonny) Montgomery VAMC

Jackson, Michigan, 39216, United States

Location

Mayo Clinic Hospital

Rochester, Minnesota, 55902, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

New York - Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11716, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

PMG Infectious Disease Consultants (administrative)

Portland, Oregon, 92775, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 92037, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital at TMC

Houston, Texas, 77030, United States

Location

VCU Health Medical Center

Richmond, Virginia, 23298, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Providence Health Care

Spokane, Washington, 99204, United States

Location

Providence Health Care, 5633 N Lidgerwood

Spokane, Washington, 99208, United States

Location

MultiCare Good Samaritan Hospital

Tacoma, Washington, 98405, United States

Location

Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas

Campinas, 13060-904, Brazil

Location

Hospital Nossa Senhora das Gracas

Curitiba, 80810-040, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, 01323-020, Brazil

Location

Centro Hospitalar Cova da Beira EPE

Covilha, 6200-251, Portugal

Location

Hospital Nélio Mendonça,

Funchal, 9000-514, Portugal

Location

Centro Hospitalar Lisboa Ocidental

Lisbon, 1449-005, Portugal

Location

Centro Hospitalar do Porto - Hospital de Santo Antonio

Odivelas, 2620-144, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, 4434-502, Portugal

Location

George Regional Hospital

George, 6529, South Africa

Location

Mediclinic Vergelegen

Somerset West, 7130, South Africa

Location

Hospital Universitario Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital General Universitario de Elche

Elche, 3203, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 37007, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Barts Health NHS Trust, The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (2)

• Sise 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.

  PMID: 38913574 DERIVED

• 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.

  PMID: 36695483 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: March 31, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 24, 2022
• Last Updated: May 12, 2023
• Results First Posted: May 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

BR (4); ES (8); ZA (2); US (41); PT (5); GB (3)