Acute Respiratory Distress SyndromePhase 2NCT04478071

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

A Phase 2 study testing vadadustat in people with Acute Respiratory Distress Syndrome and Coronavirus Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Respiratory Distress Syndrome, Coronavirus Infection
What is being tested?: vadadustat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 448 participants
Where: 1 siteUnited States
Study dates: 22 Aug 2020to 25 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Acute Respiratory Distress Syndrome, Coronavirus Infection
Being tested: vadadustat, placebo
Keywords: COVID-19, ARDS
Medical subject headings: Respiratory Distress Syndrome, Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vadadustatDrug
Also called AKB-6548
Participants will receive vadadustat once daily for 14 days.
placeboDrug
Participants will receive matching placebo once daily for 14 days.

Study groups in NCT04478071
Study group	Role	What they receive
vadadustat	Experimental	Not described Receives: Drug: vadadustat
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: day 14

Secondary outcomes (1)

Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale
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.
Measured: day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202025 Mar 2022

First posted20 Jul 2020
Study start22 Aug 2020
Primary completion7 Mar 2022
Study completion25 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 448 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04478071
Sponsor's protocol ID: HSC-MS-20-0395
Other IDs: W81XWH-21-10032
Status last verified: Mar 2025
First submitted: 15 Jul 2020
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Respiratory Distress Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
ClinicalTrials.gov ID: NCT04478071
Acronym / sponsor ID: HSC-MS-20-0395
Conditions: Acute Respiratory Distress Syndrome, Coronavirus Infection
Keywords: COVID-19, ARDS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 448 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Akebia Therapeutics, United States Department of Defense
Study start: 22 Aug 2020 (actual)
Primary completion: 7 Mar 2022 (actual)
Study completion: 25 Mar 2022 (actual)
First posted: 20 Jul 2020 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
vadadustat	Experimental	Drug: vadadustat
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vadadustatAlso: AKB-6548Participants will receive vadadustat once daily for 14 days.	Drug	vadadustat
placeboParticipants will receive matching placebo once daily for 14 days.	Drug	placebo

Primary outcome

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

1 secondary outcome

Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale
Time frame: day 14

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vadadustat	221	215
Placebo	227	221

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Vadadustat n = 216	Placebo n = 223
Value	43	53

Vadadustat vs Placebo: Risk Difference (RD): -0.036 (95% CI -0.084 to 0.009)
Vadadustat vs Placebo: Posterior Probability: 0.94

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vadadustat	61 of 221 (27.6%)	109 of 221 (49.3%)	19 of 221
Placebo	73 of 227 (32.2%)	116 of 227 (51.1%)	19 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bentley J. Bobrow, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04478071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.