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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-29

Study Completion Date

2022-02-11

Brief Summary

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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

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Detailed Description

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Conditions

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COVID-19 Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telacebec (Q203) with COVID-19 standard of care (SoC)

Group Type EXPERIMENTAL

Telacebec

Intervention Type DRUG

Telacebec 100 mg tablet

COVID-19 Standard of care

Intervention Type DRUG

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

COVID-19 Standard of care (SoC)

Group Type ACTIVE_COMPARATOR

COVID-19 Standard of care

Intervention Type DRUG

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

Interventions

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Telacebec

Telacebec 100 mg tablet

Intervention Type DRUG

COVID-19 Standard of care

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

Intervention Type DRUG

Other Intervention Names

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Q203

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No