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ODYSSEY: Tradipitant for Severe or Critical COVID-19 Infection

This study, called ODYSSEY, is testing an investigational drug called tradipitant to see if it can help people with severe or critical COVID-19 infection. Researchers want to find out if tradipitant is safe and effective in treating the lung inflammation caused by the virus. You might be able to join if you are an adult aged 18-90, have a confirmed COVID-19 infection, and meet the hospital's criteria for severe or critical COVID-19 with pneumonia and fever. The main goal is to see how quickly participants improve on a 7-point scale, measured at 14 days or when they leave the hospital. The current status of the study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving 300 participants. Participants will be randomly assigned to receive either tradipitant or a placebo.
What's involved
If you join, you will receive either tradipitant or a placebo twice daily by mouth, in addition to standard COVID-19 care. You will have daily assessments of your NEWS 2 score and daily blood tests for inflammatory markers.
Compensation
Not stated in the trial record.
Follow-up
Your improvement will be measured at 14 days or upon hospital discharge.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04326426

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

Enrolling by Invitation
PHASE3Ages 18–90InterventionalTreatment
Vanda Pharmaceuticals
~300 participants
Updated 2020-04-20 on ClinicalTrials.gov
What's tested:TradipitantPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to improvement on a 7-point ordinal scale as compared to baseline
Measured over 14 days or discharge

Conditions

Coronavirus Infection

Explore related trials

COVID-19 Infection

Where it's being run

1 sites across 1 states
New York1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Time to improvement on a 7-point ordinal scale as compared to baseline14 days or discharge