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Study population not regularly admitted to hospital and approaches have shifted away from repurposing old drugs.
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This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus | Active Comparator | Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg |
|
| Placebo | Placebo Comparator | Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus 1 MG/ML | Drug | Oral solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment | SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR | Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SARS-CoV-2 viral burden at days 1-6 | SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR | Days 1, 2, 3, 4, 5, and 6 post-dose for all patients |
| Rate of treatment emergent adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter K Kraft, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Oral solution |
|
Safety and tolerability of sirolimus in patients with COVID-19
| Days 1, 2, 3, 4, 5, and 6 post-dose for all patients |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |