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Neurokinin-1 Receptor Antagonist

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

Phase 3
Waitlist Available
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 375 Patients • NCT03568331
4%
Upper respiratory tract infection
4%
Headache
3%
Diarrhoea
2%
Dermatitis atopic
1%
Choking
1%
Dyshidrotic eczema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tradipitant
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TradipitantExperimental Treatment1 Intervention
Tradipitant 85 mg PO BID
Group II: PlaceboPlacebo Group1 Intervention
2 capsules of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
18,927 Total Patients Enrolled
~53 spots leftby Dec 2025