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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04478071
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Akebia Therapeutics Inc.
Information provided by (Responsible Party):
Bentley J. Bobrow, The University of Texas Health Science Center, Houston

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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Coronavirus Infection Drug: vadadustat Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date : August 22, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022


Arm Intervention/treatment
Experimental: vadadustat Drug: vadadustat
Participants will receive vadadustat once daily for 14 days.
Other Name: AKB-6548

Placebo Comparator: placebo Drug: placebo
Participants will receive matching placebo once daily for 14 days.




Primary Outcome Measures :
  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 Outcome Measures :
  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, 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 24 hours of hospital admission
  • Oxygen saturation of hemoglobin by pulse oximetry at room air ≤94%
  • Participation in any other clinical trial for the treatment for COVID-19 is not allowed
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

  • Males with hemoglobin > 17.5 g/dl or females >15.5 g/dl.
  • 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
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >2.0 x ULN at randomization
  • Patients who have erythrocytosis or polycythemia vera
  • Patient taking Probenecid as it can increase vadadustat exposure.
  • Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
  • Patients on maintenance dialysis
  • Patients who have received a solid organ transplant
  • Patients who are prisoners
  • Do Not Resuscitate (DNR)/Do Not Intubate (DNI) patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478071


Contacts
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Contact: Bentley J. Bobrow, MD 713-500-7863 Bentley.J.Bobrow@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Bentley J. Bobrow, MD    713-500-7863    Bentley.J.Bobrow@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Akebia Therapeutics Inc.
Investigators
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Principal Investigator: Bentley J. Bobrow, MD The University of Texas Health Science Center, Houston
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Responsible Party: Bentley J. Bobrow, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04478071    
Other Study ID Numbers: HSC-MS-20-0395
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bentley J. Bobrow, The University of Texas Health Science Center, Houston:
COVID-19
ARDS
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury
Respiratory Tract Infections