ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection

Conditions

• Coronavirus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Tradipitant — DRUG
  Neurokinin-1 antagonist
• Placebo — DRUG
  Matching placebo

Study Details

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.

Key Dates

Start date

Apr 13, 2020

Status verified

Apr 2020

Primary completion

Aug 1, 2020

Completion

Aug 31, 2020

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tradipitant
  Tradipitant 85 mg PO BID
• Placebo Comparator: Placebo
  2 capsules of matching placebo

Primary Outcome Measure

Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ]

Locations (1)

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