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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infection
• Intervention / Treatment: Drug: Placebo; Drug: Tradipitant

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Publications and helpful links

General Publications

• Smieszek SP, Przychodzen BP, Polymeropoulos VM, Polymeropoulos CM, Polymeropoulos MH. Assessing the potential correlation of polymorphisms in the IL6R with relative IL6 elevation in severely ill COVID-19 patients'. Cytokine. 2021 Dec;148:155662. doi: 10.1016/j.cyto.2021.155662. Epub 2021 Jul 29. Erratum In: Cytokine. 2022 Jan;149:155752.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: VLY-686-3501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No