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Enrolling by Invitation

NCT Number: NCT04326426

ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating 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.

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lenox Hill Hospital Northwell Health

New York, 10075, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tradipitant

Drug

Neurokinin-1 antagonist

Placebo

Drug

Matching placebo

Primary outcomes

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

    Time frame: 14 days or discharge

Secondary outcomes

  1. Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

    Time frame: 14 days or discharge

  2. Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

    Time frame: 14 days or discharge

  3. In-hospital mortality

    Time frame: 14 days or discharge

  4. Mean change in NEWS2 score from baseline

    Time frame: 14 days or discharge

  5. 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

  6. Reduction from baseline of NRS for cough

    Time frame: 14 days or discharge

  7. Reduction from baseline of NRS for nausea

    Time frame: 14 days or discharge

  8. Time to normalization of fever for at least 48 hours

    Time frame: 14 days or discharge

  9. Time to improvement in oxygenation for at least 48 hours

    Time frame: 14 days or discharge

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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