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

Study Overview
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Brief Summary
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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.

Official Title
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ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Drug: Tradipitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br>Tradipitant 85 mg PO BID | Drug: Tradipitant<br>* Neurokinin-1 antagonist<br>|
| Placebo Comparator: Placebo<br>2 capsules of matching placebo | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to improvement on a 7-point ordinal scale as compared to baseline |  | 14 days or discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Reduction from baseline of NRS for nausea |  | 14 days or discharge | 
| Time to normalization of fever for at least 48 hours |  | 14 days or discharge | 
| Time to improvement in oxygenation for at least 48 hours |  | 14 days or discharge |