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

Coronavirus Infection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04326426
• Other study ID #: VLY-686-3501
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 13, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: August 31, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Lenox Hill Hospital Northwell Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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