NCT04326426

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

ENROLLING BY INVITATION Phase 3 Last updated 20 April 2020

What this trial tests

Phase 3 trial testing Tradipitant in Coronavirus Infection in 300 participants. Enrolling by invitation.

Timeline

13 April 2020

Primary endpoint
1 August 2020

31 August 2020

Quick facts

Lead sponsor	Vanda Pharmaceuticals
Phase	Phase 3
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	300
Start date	13 April 2020
Primary completion	1 August 2020
Estimated completion	31 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Tradipitant — full drug profile →
• Placebo

Conditions studied

• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Vanda Pharmaceuticals — full company profile →

Who can join

Adults 18 to 90, any sex, with Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
2. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
3. COVID-19 and Cancer: a Comprehensive Review.
   Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
4. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
5. Wuhan to World: The COVID-19 Pandemic.
   Kumar A, Singh R, Kaur J, Pandey S, et al · · 2021 · cited 109× · PMID 33859951 · DOI 10.3389/fcimb.2021.596201
6. FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2020 · cited 105× · PMID 32717568 · DOI 10.1016/j.drup.2020.100719
7. Small molecules in the treatment of COVID-19.
   Lei S, Chen X, Wu J, Duan X, et al · · 2022 · cited 74× · PMID 36464706 · DOI 10.1038/s41392-022-01249-8
8. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895