Clinical Trial

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

Enrolling by Invitation Phase 3

Record status

This record was last updated April 20, 2020 (before its estimated August 1, 2020 completion). Its status may not reflect the trial's current state.

Summary

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2020-03-27; most recent amendment 2024-04-01.

Status change: Enrolling by Invitation → Terminated 2024-04-01

Status change: Not Yet Recruiting → Enrolling by Invitation 2020-04-16

Trial Details

NCT Number	NCT04326426
Lead Sponsor	Vanda Pharmaceuticals
Conditions	Coronavirus Infection
Enrollment	300 participants
Start Date	2020-04-13
Primary Completion	2020-08-01 (estimated)
Study Completion	2020-08-31 (estimated)
Updated on ClinicalTrials.gov	2020-04-20