Phase 2
N=448
Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Acute Respiratory Distress Syndrome · Coronavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04478071 ↗Enrolled (actual)
448
Serious AEs
29.9%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale — 43; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vadadustat (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale |
43; 53 | — |
| SECONDARY Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale |
156; 157 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04478071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.