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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) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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 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

NCT04745351•Gilead Sciences

View on ClinicalTrials.gov

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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)

Locations (63)

St. Vincent's Health System

Birmingham, Alabama, United States

UAB Hospital

Birmingham, Alabama, United States

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States

St. Joseph Hospital Eureka

Eureka, California, United States

Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave

Irvine, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

MedStar Health Research Institute

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

George Washington Medical Faculty Associates

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

Key Dates

Start Date

March 31, 2021

Primary Completion Date

April 20, 2022

Completion Date

May 24, 2022

Last Updated

May 12, 2023

Enrollment

249

ACTUAL participants

Conditions

COVID-19

Interventions

Remdesivir

DRUG

RDV Placebo

DRUG

Standard of Care

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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