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

Phase 2

Completed

Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
vadadustat	vadadustat	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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	day 14	National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 14	Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4.The MSOFA scale total score is the sum of the score for the 5 organ systems. Total score ranges from 0 to 20, a higher score indicates a worse outcome. Discharged patients will be assigned a score of 0 and dead patients a score of 20.