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vadadustat for Coronavirus
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Awards & highlights
Study Summary
This study is evaluating whether a drug may help prevent or treat acute respiratory distress syndrome.
Eligible Conditions
- Coronavirus
- Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Number of participants with a total score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) scale
Other outcome measures
Number of participants with acute kidney injury
Number of participants with hypotension
Overall survival
+3 moreTrial 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
856 Previous Clinical Trials
225,146 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,672 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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