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

COVID-19 Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04847583
• Other study ID #: Q203-COVID-P2-ZA001
• Status: Terminated
• Phase: Phase 2
• Start date: July 29, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: April 2021
• Source: Qurient Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Virus Infection

Intervention

Drug:
• Telacebec
Telacebec 100 mg tablet
• COVID-19 Standard of care
The Standard of Care treatment and administration thereof will be determined by the Investigator

Locations

Country	Name	City	State
South Africa	KwaPhila Health Solutions	Durban	Kwa-Zula Natal
South Africa	TASK Eden	George	Western Cape
South Africa	Chris Hani Baragwanath Academic Hospital	Soweto	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Qurient Co., Ltd.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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