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

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

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

Study Overview

• Status: Terminated
• Conditions: COVID-19 Virus Infection
• Intervention / Treatment: Drug: Telacebec; Drug: COVID-19 Standard of care

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Soweto, Gauteng, South Africa
      • Chris Hani Baragwanath Academic Hospital
  • Kwa-Zula Natal
    • Durban, Kwa-Zula Natal, South Africa
      • KwaPhila Health Solutions
  • Western Cape
    • George, Western Cape, South Africa
      • TASK Eden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provide written, informed consent prior to all study-related procedures.
2. Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
3. Willingness and ability to attend scheduled visits and undergo study assessments.
4. Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
5. Male or female aged 18 years or older.
6. Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
7. Clinical and/or radiological findings indicative of moderate COVID-19 disease

Exclusion Criteria:

1. Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
2. Inability to swallow oral medication.
3. 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.
4. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Qurient Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 12, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Q203-COVID-P2-ZA001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No