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Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

NCT04478071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2025-03-26

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).

Conditions

  • Acute Respiratory Distress Syndrome
  • Coronavirus Infection

Interventions

DRUG

vadadustat

Participants will receive vadadustat once daily for 14 days.

DRUG

placebo

Participants will receive matching placebo once daily for 14 days.

Sponsors & Collaborators

  • Akebia Therapeutics Inc.

    collaborator UNKNOWN

  • United States Department of Defense

    collaborator FED

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Bentley J. Bobrow, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-22
Primary Completion
2022-03-07
Completion
2022-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04478071 on ClinicalTrials.gov