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

• ClinicalTrials.gov Identifier: NCT04326426
• Recruitment Status: Unknown
• First Posted: March 30, 2020
• Last Update Posted: April 20, 2020
• Sponsor: Vanda Pharmaceuticals
• Information provided by (Responsible Party): Vanda Pharmaceuticals

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New York

Lenox Hill Hospital Northwell Health

New York, New York, United States, 10075

Sponsors and Collaborators

Vanda Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04326426
• Other Study ID Numbers: VLY-686-3501
• First Posted: March 30, 2020
• Last Update Posted: April 20, 2020
• Last Verified: April 2020

• 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:

Infections; Communicable Diseases; Coronavirus Infections; Disease Attributes; Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases