Clinical trial NCT04478071: Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Official title: Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Coronavirus Infection
Keywords: COVID-19
ARDS
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Akebia Therapeutics Inc.
name: United States Department of Defense
First posted: 2020-07-20
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale
timeFrame: day 14
Other outcomes:
measure: Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale
timeFrame: day 7
measure: Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale
timeFrame: day 14
measure: Ventilator-free Survival
timeFrame: day 7
measure: Ventilator-free Survival
timeFrame: day 14
measure: Overall Survival
timeFrame: day 7
measure: Overall Survival
timeFrame: day 14
measure: Number of Participants With Hypotension
timeFrame: day 7
measure: Number of Participants With Hypotension
timeFrame: day 14
measure: Number of Participants With Acute Kidney Injury
timeFrame: day 7
measure: Number of Participants With Acute Kidney Injury
timeFrame: day 14
measure: Time to Hospital Discharge
timeFrame: From the time of hospital admission to hospital discharge (about 7 days)
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Bentley J. Bobrow, MD
role: PRINCIPAL_INVESTIGATOR
References: