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Trial record 2 of 10 for:    tradipitant

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326426
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Tradipitant Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tradipitant
Tradipitant 85 mg PO BID
Drug: Tradipitant
Neurokinin-1 antagonist

Placebo Comparator: Placebo
2 capsules of matching placebo
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ]

Secondary Outcome Measures :
  1. Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) [ Time Frame: 14 days or discharge ]
  2. Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples [ Time Frame: 14 days or discharge ]
  3. In-hospital mortality [ Time Frame: 14 days or discharge ]
  4. Mean change in NEWS2 score from baseline [ Time Frame: 14 days or discharge ]
  5. 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 ]
  6. Reduction from baseline of NRS for cough [ Time Frame: 14 days or discharge ]
  7. Reduction from baseline of NRS for nausea [ Time Frame: 14 days or discharge ]
  8. Time to normalization of fever for at least 48 hours [ Time Frame: 14 days or discharge ]
  9. Time to improvement in oxygenation for at least 48 hours [ Time Frame: 14 days or discharge ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326426


Locations
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United States, New York
Lenox Hill Hospital Northwell Health
New York, New York, United States, 10075
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04326426    
Other Study ID Numbers: VLY-686-3501
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases