ClinicalTrials.gov

History of Changes for Study: NCT04326426
COVIDL1: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
Latest version (submitted April 16, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 27, 2020 None (earliest Version on record)
2 April 2, 2020 Study Status and Study Identification
3 April 16, 2020 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
Comparison Format:

Scroll up to access the controls

Study NCT04326426
Submitted Date:  March 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: VLY-686-3501
Brief Title: COVIDL1: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
Official Title: COVIDL1: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: April 1, 2020
Primary Completion: August 1, 2020 [Anticipated]
Study Completion: August 31, 2020 [Anticipated]
First Submitted: March 26, 2020
First Submitted that
Met QC Criteria:
March 27, 2020
First Posted: March 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 27, 2020
Last Update Posted: March 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vanda Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.

Detailed Description:
Open or close this module Conditions
Conditions: Coronavirus Infection
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Tradipitant
Tradipitant 85 mg PO BID
Drug: Tradipitant
Neurokinin-1 antagonist
Placebo Comparator: Placebo
2 capsules of matching placebo
Drug: Placebo
Matching placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of participants with normalization of fever and oxygen saturation by day 14
[ 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Vasilios Polymeropoulos, MD
Telephone: 2027343400
Email: vasilios.polymeropoulos@vandapharma.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services