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

StatusEnrolling by Invitation
PhasePhase 3
Started2020-04-13
View on ClinicalTrials.gov ↗
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.

Amendment history

2024-04-01
Enrolling by Invitation→Terminated Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, IPDSharing, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v3
Trial statusEnrolling by Invitation→Terminated
Reason stoppednot stated→Study met pre-defined futility criteria
Primary completion dateestimated 2020-08-01→confirmed 2021-08-03
Completion dateestimated 2020-08-31→confirmed 2021-08-03
Enrollment targetestimated 300→confirmed 153
Secondary endpoints-581 characters
Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples In-hospital mortality Mean change in NEWS2 score from baseline Understand the effect of genetics for tr [...]
Primary endpoints1 entry, revised
Time to improvementImprovement on a 7-point ordinalOrdinal scaleScale as comparedCompared to baselineBaseline
2020-04-16
Not Yet Recruiting→Enrolling by Invitation Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2020-04-01→confirmed 2020-04-13
Study sites0→1
Secondary endpoints6 to 9 entries
Reduction from baseline of NRS for nausea Time to normalization of fever for at least 48 hours Time to improvement in oxygenation for at least 48 hours
Primary endpoints1 entry, revised
ProportionTime ofto participantsimprovement withon normalizationa of7-point feverordinal andscale oxygenas saturationcompared byto day 14baseline
2020-04-02
Study Identification, Study Status v1
Study titlerevised
COVIDL1ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
2020-03-27
Original filing
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.
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