Covid 19 Research using Clinical Trials (Home Page)
Report for Q000150: NIH
(Synonyms: Co)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
Correlated MeSH Terms (4)
Correlated HPO Terms (0)
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Name (Synonyms) |
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There is one clinical trial.
Clinical Trials
This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and
safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury
associated with severe or critical COVID-19 infection.
On evaluation for enrollment, participant will need to meet all inclusion and exclusion
criteria. If participant consents, they will be randomized 1:1 to treatment with either
tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as
per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily
following randomization. Inflammatory lab markers as detailed should be collected once per
day in the morning, preferably at the same time every morning. All enrolled participants will
have whole blood collected for whole genome sequencing.
Primary Outcomes
Measure: Time to improvement on a 7-point ordinal scale as compared to baseline Time: 14 days or discharge
Secondary Outcomes
Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) Time: 14 days or discharge
Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples Time: 14 days or discharge
Measure: In-hospital mortality Time: 14 days or discharge
Measure: Mean change in NEWS2 score from baseline Time: 14 days or discharge
Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus Time: 14 days or discharge
Measure: Reduction from baseline of NRS for cough Time: 14 days or discharge
Measure: Reduction from baseline of NRS for nausea Time: 14 days or discharge
Measure: Time to normalization of fever for at least 48 hours Time: 14 days or discharge
Measure: Time to improvement in oxygenation for at least 48 hours Time: 14 days or discharge
HPO Nodes