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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 May 2020

At a glance

  • Drugs Tradipitant (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms COVIDL1; ODYSSEY
  • Sponsors Vanda Pharmaceuticals
  • Most Recent Events

    • 06 May 2020 According to a Vanda Pharmaceuticals media release, results from this study are expected in the third quarter of 2020.
    • 15 Apr 2020 According to a Vanda Pharmaceuticals media release, first patient is enrolled in Vanda's clinical trial, ODYSSEY VLY-686-3501 (NCT04326426), yesterday at Lenox Hill Hospital in New York City.
    • 15 Apr 2020 According to a Vanda Pharmaceuticals media release, Dr. Mina, Section Chief of Pulmonary Medicine, Director of Pulmonary & Critical Care Fellowship at Lenox Hill Hospital, is a lead ODYSSEY study investigator

Trial Overview

Purpose

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.

Primary Endpoints

Proportion of participants with normalization of fever and oxygen saturation by day 14

time_frame: 14 days or discharge

Other Endpoints

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

time_frame: 14 days or discharge

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

time_frame: 14 days or discharge

In-hospital mortality

time_frame: 14 days or discharge

Mean change in NEWS2 score from baseline

time_frame: 14 days or discharge

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

Reduction from baseline of NRS for cough

time_frame: 14 days or discharge

Reduction from baseline of NRS for nausea

time_frame: 14 days or discharge

Time to normalization of fever for at least 48 hours

time_frame: 14 days or discharge

Time to improvement in oxygenation for at least 48 hours

time_frame: 14 days or discharge [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 300

  • Sex male & female
  • Age Group 18-90 years; adult; elderly

Patient 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%

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04326426 ClinicalTrials.gov: US National Institutes of Health
VLY686-3501 -

Organisations

  • Sponsors Vanda Pharmaceuticals
  • Affiliations Vanda Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 13 Apr 2020

  • Primary Completion Dates

    Planned : 01 Aug 2020

  • End Dates

    Planned : 31 Aug 2020

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
TradipitantPrimary Drug Oral Capsule

Tradipitant

Tradipitant 85 mg PO BID
Drug: Tradipitant (Neurokinin-1 antagonist)

Placebo

2 capsules of matching placebo
Drug: Placebo (Matching placebo)

Trial Centres

Centres

Centre Name Location Trial Centre Country
Lenox Hill Hospital Northwell Health New York, New York USA
Vanda Pharmaceuticals
-
-

Trial History

Event Date Event Type Comment
06 May 2020 Other trial event According to a Vanda Pharmaceuticals media release, results from this study are expected in the third quarter of 2020. Updated 11 May 2020
21 Apr 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 21 Apr 2020
15 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, first patient is enrolled in Vanda's clinical trial, ODYSSEY VLY-686-3501 (NCT04326426), yesterday at Lenox Hill Hospital in New York City. Updated 22 Apr 2020
15 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, Dr. Mina, Section Chief of Pulmonary Medicine, Director of Pulmonary & Critical Care Fellowship at Lenox Hill Hospital, is a lead ODYSSEY study investigator Updated 22 Apr 2020
15 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, With the strong leadership and health expertise of Northwell Health, we expect to be able to accelerate enrollment in this study and provide results in the coming months Updated 22 Apr 2020
14 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting, according to a Vanda Pharmaceuticals media release. Updated 22 Apr 2020
02 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, the company has received FDA permission to proceed with the study and announced the initiation of this study. Updated 13 Apr 2020
02 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, the study will begin at New York area hospitals and will enroll hospitalized patients with COVID-19 ARDS. Updated 13 Apr 2020
02 Apr 2020 Other trial event According to a Vanda Pharmaceuticals media release, the company start enrolling patients this month. Updated 13 Apr 2020
01 Apr 2020 New trial record New trial record Updated 01 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Vanda Pharmaceuticals. Vanda Pharmaceuticals Announces the Initiation of ODYSSEY, an FDA Approved Clinical Study of Tradipitant in Hospitalized Patients with Severe COVID-19 Pneumonia. Media-Rel 2020;.

    Media Release
  3. Vanda Pharmaceuticals. Vanda Pharmaceuticals, Northwell Health Conduct ODYSSEY Trial In Patients With Severe COVID-19 Pneumonia. Media-Rel 2020;.

    Media Release
  4. Vanda Pharmaceuticals. Vanda Pharmaceuticals Reports First Quarter 2020 Financial Results. Media-Rel 2020;.

    Media Release
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