Clinical trial NCT04326426: ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Coronavirus Infection
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Time to improvement on a 7-point ordinal scale as compared to baseline
timeFrame: 14 days or discharge
Secondary outcomes:
measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)
timeFrame: 14 days or discharge
measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples
timeFrame: 14 days or discharge
measure: In-hospital mortality
timeFrame: 14 days or discharge
measure: Mean change in NEWS2 score from baseline
timeFrame: 14 days or discharge
measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus
timeFrame: 14 days or discharge
measure: Reduction from baseline of NRS for cough
timeFrame: 14 days or discharge
measure: Reduction from baseline of NRS for nausea
timeFrame: 14 days or discharge
measure: Time to normalization of fever for at least 48 hours
timeFrame: 14 days or discharge
measure: Time to improvement in oxygenation for at least 48 hours
timeFrame: 14 days or discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital Northwell Health
state: New York
Study officials:
References:
citation: 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.