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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)
Phase 2
Waitlist Available
Led By Bentley J. Bobrow, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Summary
This trial is testing vadadustat, a medication that may help prevent or treat severe lung problems in hospitalized COVID-19 patients. The drug works by helping the body handle low oxygen levels better. The goal is to see if it can reduce the risk or severity of acute respiratory distress syndrome (ARDS).
Eligible Conditions
- Coronavirus
- Acute Respiratory Distress Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Number of participants with a total score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) scale
Other study objectives
Number of participants with hypotension
Score on the Modified Sequential Organ Failure Assessment (MSOFA) scale
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: vadadustatExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vadadustat
2018
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
Akebia Therapeutics Inc.UNKNOWN
1 Previous Clinical Trials
214 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,268 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,408 Total Patients Enrolled
Bentley J. Bobrow, MDPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston