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

Phase 2

Terminated

• Conditions: COVID-19 Virus Infection
• Interventions: Drug: COVID-19 Standard of care; Drug: Telacebec

• Registration Number: NCT04847583
• Lead Sponsor: Qurient Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Study Start: 2021-07-29
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Last Update Submitted: 2022-02-12
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19 Standard of care (SoC)	COVID-19 Standard of care	-
Telacebec (Q203) with COVID-19 standard of care (SoC)	COVID-19 Standard of care	-
Telacebec (Q203) with COVID-19 standard of care (SoC)	Telacebec	-

Primary Outcome Measures

Name	Time	Method
Biomarker change	Day 1 and 14	Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec

Trial Locations

Locations (3)

Chris Hani Baragwanath Academic Hospital; 🇿🇦 Soweto, Gauteng, South Africa

KwaPhila Health Solutions; 🇿🇦 Durban, Kwa-Zula Natal, South Africa

TASK Eden; 🇿🇦 George, Western Cape, South Africa