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

NCT04326426 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: VLY-686-3501
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• Time to improvement on a 7-point ordinal scale as compared to baseline

  14 days or discharge

Secondary Outcomes (9)

• 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

Study Arms (2)

Tradipitant

EXPERIMENTAL

Tradipitant 85 mg PO BID

Drug: Tradipitant

Placebo

PLACEBO COMPARATOR

2 capsules of matching placebo

Drug: Placebo

Interventions

Tradipitant DRUG

Neurokinin-1 antagonist

Tradipitant

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Lenox Hill Hospital Northwell Health

New York, New York, 10075, United States

Location

Related Publications (1)

• 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.

  PMID: 34353696 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: April 13, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 31, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

US (1)