inflammatory lung injury associated with severe COVID-19 infection MedDRA version: 23.1 Level: LLT Classification code 10084383 Term: Novel COVID-19-infected pneumonia System Organ Class: 100000004862
Conditions
Interventions
Product Name: tradipitant
Product Code: VLY-686
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Vanda Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-90; 2. Confirmed laboratory COVID-19 infection; 3. Confirmed pneumonia by chest radiograph or computed tomography; 4. Fever defined as temperature = 36.6 °C armpit, = 37.2 °C oral, or = 37.8 °C rectal since admission or the use of antipyretics; 5. PaO2 / FiO2 = 300; 6. In-patient hospitalization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements; 2. Known allergy to tradipitant or other neurokinin-1 antagonists; 3. Pregnancy; 4. Uncontrolled HIV, HBV, or HCV infection; 5. Other uncontrolled medically significant diseases; 6. Enrollment in another clinical trial of an investigational therapy; 7. Alanine aminotransferase > 5X Upper Limit of Normal or Creatinine clearance 72 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of tradipitant in COVID-19 participants, as measured by the percentage of responders with an improvement of 2 or more points on a 7-point ordinal scale as compared to baseline. The 7-point ordinal scale is defined as follows: 1- Death 2- Hospitalized on mechanical ventilation or ECMO 3- Hospitalized on non-invasive ventilation or high-flow oxygen supplementation 4- Hospitalized requiring supplemental oxygen 5- Hospitalized not requiring supplemental oxygen, requiring continued medical care 6- Hospitalized not requiring supplemental oxygen, not requiring continued medical care 7- Not hospitalized;Secondary Objective: 1. Time to response on 7-point ordinal scale 2. Time to normalization of fever for at least 48 hours 3. Time to improvement in oxygenation for at least 48 hours 4. Treatment and prevention of inflammatory lung injury as measured by inflammatory markers 5. Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples 6. In-hospital mortality 7. Mean change in NEWS2 score from baseline 8. Understand the effect of genetics for treatment response, and understand genetics of COVID-19 virus 9. Reduction from baseline of NRS for cough 10. Reduction from baseline of NRS for nausea 11. Length of hospital stay;Primary end point(s): The primary endpoint is the percentage of responders at day 28, as defined by an improvement of 2 or more points on a clinical status 7-point scale as compared to baseline. The primary endpoint will be summarized in Kaplan-Meier survival curve, and the treatment difference will be tested by the log-rank test in the ITT population. The statistical analyses will be detailed in the statistical analysis plan (SAP).;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The categorical secondary endpoints from other questionnaires will be analyzed by the CMH (Cochran-Mantel-Haenszel) test. The continuous secondary endpoints will be analyzed by ANOVA/ANCOVA. The Kaplan-Meier survival curve and log-rank test will be used to analyze the time to event variable. The details will be provided in the SAP. | — |
Countries
France, United States
Contacts
Public ContactChristoph Wachter
Expertrials
Outcome results
None listed