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

NCT04847583 | Terminated Phase 2 FDA Drug

• 1 other identifier: Q203-COVID-P2-ZA001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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

Conditions

COVID-19 Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

Drug: Telacebec; Drug: COVID-19 Standard of care

COVID-19 Standard of care (SoC)

ACTIVE COMPARATOR

Drug: COVID-19 Standard of care

Interventions

Telacebec DRUG

Telacebec 100 mg tablet

Also known as: Q203

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

COVID-19 Standard of care DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qurient Co., Ltd.: lead

Study Sites (3)

Chris Hani Baragwanath Academic Hospital

Soweto, Gauteng, South Africa

Location

KwaPhila Health Solutions

Durban, Kwa-Zula Natal, South Africa

Location

TASK Eden

George, Western Cape, South Africa

Location

MeSH Terms

Conditions

COVID-19

Interventions

telacebec

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: July 29, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-04

Locations

ZA (3)