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

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Acute Respiratory Distress Syndrome

Coronavirus Infection

Treatments

Drug: placebo

Drug: vadadustat

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04478071

HSC-MS-20-0395

W81XWH-21-10032 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment

448 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory
Admitted to the hospital within 36 hours
Oxygen saturation of hemoglobin by pulse oximetry at room air ≤94%
For patients admitted WITH respiratory symptoms, enrollment must occur within 36 hours of hospital admission. If the patient is admitted to the hospital with normal saturations, but develops respiratory symptoms DURING their hospital stay, enrollment may occur within 24 hours of desaturation to 94% or less on room air
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Exclusion criteria

Hypersensitivity to vadadustat or any of its excipients
Placed on mechanical ventilation before randomization
Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 g/dL for females and 18 g/dL for males
Patients who have erythrocytosis or polycythemia vera
Patient taking Probenecid, lopinavir or ritonavir
Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
Patients not on maintenance dialysis with eGFC < 31 ml/min
Patients who have received a solid organ transplant, heart, kidney, liver or lung
Patients who are prisoners
Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI)
Patients with modified Rankin scale of 3 or greater
Patient who are currently enrolled in any other interventional clinical trial