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

NCT04478071 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HSC-MS-20-0395W81XWH-21-10032
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome; Coronavirus Infection

Keywords

COVID-19; ARDS

Outcome Measures

Primary Outcomes (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

  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

  day 14

Secondary Outcomes (1)

• Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale

  day 14

Other Outcomes (11)

• Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale

  day 7

• Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale

  day 14

• Ventilator-free Survival

  day 7

Study Arms (2)

vadadustat

EXPERIMENTAL

Drug: vadadustat

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

vadadustat DRUG

Participants will receive vadadustat once daily for 14 days.

Also known as: AKB-6548

vadadustat

placebo DRUG

Participants will receive matching placebo once daily for 14 days.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Akebia Therapeutics Inc.: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections; COVID-19

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections

Results Point of Contact

• Title: Bentley J. Bobrow, MD
• Organization: The University of Texas Health Science Center at Houston

Bentley.J.Bobrow@uth.tmc.edu

713-500-7863

Study Officials

• Bentley J. Bobrow, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: August 22, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 25, 2022
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)