Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hosp⦠(NCT04478071) | Clinical Trial Compass
CompletedPhase 2
Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
United States448 participantsStarted 2020-08-22
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 ā¤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 Nā¦
What they're measuring
1
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
Timeframe: day 14
Trial details
NCT IDNCT04478071
SponsorThe University of Texas Health Science Center, Houston