Status:
ENROLLING_BY_INVITATION
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 sever...
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
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04326426
Start Date
April 13 2020
End Date
August 31 2020
Last Update
April 20 2020
Active Locations (1)
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1
Lenox Hill Hospital Northwell Health
New York, New York, United States, 10075