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Sponsor's Decision
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telacebec (Q203) with COVID-19 standard of care (SoC) | Experimental |
| |
| COVID-19 Standard of care (SoC) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telacebec | Drug | Telacebec 100 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris Hani Baragwanath Academic Hospital | Soweto | Gauteng | South Africa | |||
| KwaPhila Health Solutions |
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| COVID-19 Standard of care | Drug | The Standard of Care treatment and administration thereof will be determined by the Investigator |
|
| Durban |
| Kwa-Zula Natal |
| South Africa |
| TASK Eden | George | Western Cape | South Africa |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C584497 | telacebec |
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