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

Phase 3

• Conditions: Coronavirus Infection
• Interventions: Drug: Placebo; Drug: Tradipitant

• Registration Number: NCT04326426
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Status Verified: 2020-04
• Study Start: 2020-04-13
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adults aged 18-90
• Confirmed laboratory COVID-19 infection by RT-PCR
• Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital
• Confirmed pneumonia by chest radiograph or computed tomography
• Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
• Oxygen saturation less than 92%

Exclusion Criteria

• Recent use of illicit drugs or alcohol abuse
• Known allergy to tradipitant or other neurokinin-1 antagonists
• Pregnancy
• Known HIV, HBV, or HCV infection
• Malignant tumor, other serious systemic diseases
• Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 capsules of matching placebo
Tradipitant	Tradipitant	Tradipitant 85 mg PO BID

Primary Outcome Measures

Name	Time	Method
Time to improvement on a 7-point ordinal scale as compared to baseline	14 days or discharge

Secondary Outcome Measures

Name	Time	Method
Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus	14 days or discharge
Reduction from baseline of NRS for cough	14 days or discharge
Time to normalization of fever for at least 48 hours	14 days or discharge
Reduction from baseline of NRS for nausea	14 days or discharge
Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)	14 days or discharge
Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples	14 days or discharge
In-hospital mortality	14 days or discharge
Mean change in NEWS2 score from baseline	14 days or discharge
Time to improvement in oxygenation for at least 48 hours	14 days or discharge

Trial Locations

Locations (1)

Lenox Hill Hospital Northwell Health; 🇺🇸 New York, New York, United States