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Completed

NCT Number: NCT04478071

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

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).

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Key information

Conditions

Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infection Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vadadustat

Drug

Participants will receive vadadustat once daily for 14 days.

Other names: AKB-6548

Placebo

Drug

Participants will receive matching placebo once daily for 14 days.

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

    Time frame: day 14

    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

Secondary outcomes

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

    Time frame: day 14

    Modified Sequential Organ Failure Assessment (MSOFA) scale:

    Each of 5 organ systems is given a score of 0 to 4.The MSOFA scale total score is the sum of the score for the 5 organ systems. Total score ranges from 0 to 20, a higher score indicates a worse outcome. Discharged patients will be assigned a score of 0 and dead patients a score of 20.

Other outcomes

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

    Time frame: day 7

    Modified Sequential Organ Failure Assessment (MSOFA) scale:

    Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20.

    • Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150)
    • Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice)
    • Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1)
    • Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6)
    • Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0)

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

    Time frame: day 14

    Modified Sequential Organ Failure Assessment (MSOFA) scale:

    Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20.

    • Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150)
    • Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice)
    • Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1)
    • Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6)
    • Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0)

  3. Ventilator-free Survival

    Time frame: day 7

  4. Ventilator-free Survival

    Time frame: day 14

  5. Overall Survival

    Time frame: day 7

  6. Overall Survival

    Time frame: day 14

  7. Number of Participants With Hypotension

    Time frame: day 7

    Hypotension is defined as Mean Arterial Pressure (MAP) <70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure.

  8. Number of Participants With Hypotension

    Time frame: day 14

    Hypotension is defined as Mean Arterial Pressure (MAP) <70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure.

  9. Number of Participants With Acute Kidney Injury

    Time frame: day 7

  10. Number of Participants With Acute Kidney Injury

    Time frame: day 14

  11. Time to Hospital Discharge

    Time frame: From the time of hospital admission to hospital discharge (about 7 days)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Akebia Therapeutics
  • United States Department of Defense

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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