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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)

NCT04745351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2023-05-12

Study results available
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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

Interventions

DRUG

Remdesivir

Administered as Intravenous (IV) infusion once daily

DRUG

RDV Placebo

Administered as IV saline once daily

DRUG

Standard of Care

Standard of Care Treatment for COVID-19 Infection

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-04-20
Completion
2022-05-24
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Portugal
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745351 on ClinicalTrials.gov