Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Unknown
Verified April 2020 by Vanda Pharmaceuticals.
Recruitment status was:  Enrolling by invitation
First Posted : March 30, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE March 30, 2020
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE April 13, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
Proportion of participants with normalization of fever and oxygen saturation by day 14 [ Time Frame: 14 days or discharge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Infection
Intervention  ICMJE
  • Drug: Tradipitant
    Neurokinin-1 antagonist
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Tradipitant
    Tradipitant 85 mg PO BID
    Intervention: Drug: Tradipitant
  • Placebo Comparator: Placebo
    2 capsules of matching placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 27, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04326426
Other Study ID Numbers  ICMJE VLY-686-3501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vanda Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanda Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP