Back to results

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

Primary Purpose

Coronavirus Infection

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tradipitant

Placebo

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lenox Hill Hospital Northwell Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tradipitant

Placebo

Arm Description

Tradipitant 85 mg PO BID

2 capsules of matching placebo

Outcomes

Primary Outcome Measures

Time to improvement on a 7-point ordinal scale as compared to baseline

Secondary Outcome Measures

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

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

In-hospital mortality

Mean change in NEWS2 score from baseline

Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

Reduction from baseline of NRS for cough

Reduction from baseline of NRS for nausea

Time to normalization of fever for at least 48 hours

Time to improvement in oxygenation for at least 48 hours

Full Information

NCT ID

NCT04326426

First Posted

March 26, 2020

Last Updated

April 16, 2020

Sponsor

Vanda Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04326426

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 13, 2020 (Actual)

Primary Completion Date

August 1, 2020 (Anticipated)

Study Completion Date

August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vanda Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tradipitant

Arm Type

Experimental

Arm Description

Tradipitant 85 mg PO BID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 capsules of matching placebo

Intervention Type

Drug

Intervention Name(s)

Tradipitant

Intervention Description

Neurokinin-1 antagonist

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Time to improvement on a 7-point ordinal scale as compared to baseline

Time Frame

14 days or discharge

Secondary Outcome Measure Information:

Title

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

Time Frame

14 days or discharge

Title

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

Time Frame

14 days or discharge

Title

In-hospital mortality

Time Frame

14 days or discharge

Title

Mean change in NEWS2 score from baseline

Time Frame

14 days or discharge

Title

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

Title

Reduction from baseline of NRS for cough

Time Frame

14 days or discharge

Title

Reduction from baseline of NRS for nausea

Time Frame

14 days or discharge

Title

Time to normalization of fever for at least 48 hours

Time Frame

14 days or discharge

Title

Time to improvement in oxygenation for at least 48 hours

Time Frame

14 days or discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Lenox Hill Hospital Northwell Health

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34353696

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. Erratum In: Cytokine. 2022 Jan;149:155752.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs