Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 24 hours of hospital admission
  • Oxygen saturation of hemoglobin by pulse oximetry at room air ≤94%
  • Participation in any other clinical trial for the treatment for COVID-19 is not allowed
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Exclusion Criteria

  • Males with hemoglobin > 17.5 g/dl or females >15.5 g/dl.
  • 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
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >2.0 x ULN at randomization
  • Patients who have erythrocytosis or polycythemia vera
  • Patient taking Probenecid as it can increase vadadustat exposure.
  • Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
  • Patients on maintenance dialysis
  • Patients who have received a solid organ transplant
  • Patients who are prisoners
  • Do Not Resuscitate (DNR)/Do Not Intubate (DNI) patients

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
vadadustat
  • Drug: vadadustat
    Participants will receive vadadustat once daily for 14 days.
    Other names:
    • AKB-6548
Placebo Comparator
placebo
  • Drug: placebo
    Participants will receive matching placebo once daily for 14 days.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Bentley J. Bobrow, MD
713-500-7863
Bentley.J.Bobrow@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Bentley J. Bobrow, MD
713-500-7863
Bentley.J.Bobrow@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.