A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease

Official Title
-----------------
A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease

Conditions
-----------------
COVID-19 Virus Infection

Intervention / Treatment
-----------------
* Drug: Telacebec
* Drug: COVID-19 Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written, informed consent prior to all study-related procedures. Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing. Willingness and ability to attend scheduled visits and undergo study assessments. Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary. Male or female aged 18 years or older. Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation. Clinical and/or radiological findings indicative of moderate COVID-19 disease Exclusion Criteria: Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator. Inability to swallow oral medication. Concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the Investigator. Female Participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. Males planning to conceive a child during the study or within 6 months of cessation of treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telacebec (Q203) with COVID-19 standard of care (SoC)<br> | Drug: Telacebec<br>* Telacebec 100 mg tablet<br>* Other names: Q203;Drug: COVID-19 Standard of care<br>* The Standard of Care treatment and administration thereof will be determined by the Investigator<br>|
| Active Comparator: COVID-19 Standard of care (SoC)<br> | Drug: COVID-19 Standard of care<br>* The Standard of Care treatment and administration thereof will be determined by the Investigator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker change | Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec | Day 1 and 14 |