Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
NCT ID: NCT04478071
Last Updated: 2025-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
448 participants
INTERVENTIONAL
2020-08-22
2022-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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vadadustat
vadadustat
Participants will receive vadadustat once daily for 14 days.
placebo
placebo
Participants will receive matching placebo once daily for 14 days.
Interventions
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vadadustat
Participants will receive vadadustat once daily for 14 days.
placebo
Participants will receive matching placebo once daily for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Akebia Therapeutics Inc.
UNKNOWN
United States Department of Defense
FED
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Bentley J. Bobrow
Professor
Principal Investigators
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Bentley J. Bobrow, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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W81XWH-21-10032
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC-MS-20-0395
Identifier Type: -
Identifier Source: org_study_id
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