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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04847583

Enrollment

Registered

2021-04-19

Start date

2021-07-29

Completion date

2022-02-11

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Virus Infection

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

Interventions

DRUGTelacebec

Telacebec 100 mg tablet

DRUGCOVID-19 Standard of care

The Standard of Care treatment and administration thereof will be determined by the Investigator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026