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Enrolling by invitation NCT04326426

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

Phase III Interventional Coronavirus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tradipitant, Placebo.
Who it may be relevant to
Registry conditions: Coronavirus Infection. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tradipitant
    Neurokinin-1 antagonist
  • Drug Placebo
    Matching placebo

Primary outcome measures

  • Time to improvement on a 7-point ordinal scale as compared to baseline [Time frame: 14 days or discharge]
Secondary outcome measures (9)
  • Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) [Time frame: 14 days or discharge]
  • Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples [Time frame: 14 days or discharge]
  • In-hospital mortality [Time frame: 14 days or discharge]
  • Mean change in NEWS2 score from baseline [Time frame: 14 days or discharge]
  • Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus [Time frame: 14 days or discharge]
  • Reduction from baseline of NRS for cough [Time frame: 14 days or discharge]
  • Reduction from baseline of NRS for nausea [Time frame: 14 days or discharge]
  • Time to normalization of fever for at least 48 hours [Time frame: 14 days or discharge]
  • Time to improvement in oxygenation for at least 48 hours [Time frame: 14 days or discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Lenox Hill Hospital Northwell Health — New York

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. PMID 34353696

Identifiers

NCT: NCT04326426 · VLY-686-3501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗