Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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).

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

Keywords

COVID-19 Remdesivir Remdesivir (RDV)

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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
  • Severely reduced kidney function (estimated Glomerular Filtration Rate [eGFR] < 30 milliliters per minute per 1.73 square meters [mL/min/1.73 m2]), including people with ESKD requiring chronic dialysis

  • The interval between COVID-19 symptoms onset and randomization is no more than 10 days

You CAN'T join 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, ECMO, or 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

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States
  • Medical University of South Carolina accepting new patients
    Charleston South Carolina 92037 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave accepting new patients
    Irvine California 92618 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04745351
Phase
Phase 3
Study Type
Interventional
Last Updated