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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    650
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 6 November 2021
oxygen saturation
respiratory distress
acute respiratory distress
covid-19
SARS
respiratory symptoms
coronavirus
oximetry
respiratory symptom
acute respiratory distress syndrome

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).

Details
Condition ADULT RESPIRATORY DISTRESS SYNDROME, Coronavirus Infection, Pulmonary Disease, acute respiratory distress syndrome, Coronavirus, ards, Acute Respiratory Distress, Acute Respiratory Distress Syndrome (ARDS), Lung Disease
Treatment Placebo, vadadustat
Clinical Study IdentifierNCT04478071
SponsorThe University of Texas Health Science Center, Houston
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

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
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
Oxygen saturation of hemoglobin by pulse oximetry at room air 94%
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
Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 g/dL for females and 18 g/dL for males
Placed on mechanical ventilation before randomization
Patient taking Probenecid, lopinavir or ritonavir
Patients who have erythrocytosis or polycythemia vera
Patients not on maintenance dialysis with eGFC < 31 ml/min
Patients who have received a solid organ transplant, heart, kidney, liver or lung
Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI)
Patients with modified Rankin scale of 3 or greater
Patients who are prisoners
Patient who are currently enrolled in any other interventional clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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