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| Name | Class |
|---|---|
| Nova Scotia Health Authority | OTHER |
| Dalhousie University | OTHER |
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Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Moderate and severe, not critical disease |
|
| Remdesivir | Experimental | Moderate and severe, not critical disease |
|
| Remdesivir + baricitinib | Experimental | Moderate and severe, not critical disease |
|
| Tocilizumab | Experimental | Severe, critical disease |
|
| Clinical standard of care | No Intervention | Moderate and severe, not critical disease AND severe, critical disease as applicable |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib (janus kinase inhibitor) | Drug | Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status of subject at day 15 (on a 7 point ordinal scale). |
| Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm | Up to 180 days |
Inclusion Criteria:
Patients will be further distinguished based on their disease severity into one of two categories:
Exclusion Criteria:
Baricitinib:
Tocilizumab:
Remdesivir:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 1V7 | Canada |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
| D000075242 | Janus Kinase Inhibitors |
| C000606551 | remdesivir |
| D000998 | Antiviral Agents |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Remdesivir (antiviral) + barictinib (janus kinase inhibitor) | Drug | Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner. |
|
| Remdesivir (antiviral) | Drug | Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). |
|
| Tocilizumab (interleukin 6 inhibitor) | Drug | Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg. |
|
| Up to 180 days |
| Length of time to clinical improvement | Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours. | Up to 29 days |
| Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29 | Up to 29 days |
| Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment | Up to 24 weeks |
| Length of time to clinical progression | Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission | Up to 29 days |
| Cause of death (if applicable) | Up to 24 weeks |
| Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean) | Up to 29 days |
| Length of time to normalization of fever | Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours | Up to 29 days |
| Length of time to normalization of oxygen saturation | Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours. | Up to 29 days |
| Duration of supplemental oxygen (if applicable) | Up to 29 days |
| Duration of mechanical ventilation (if applicable) | Up to 29 days |
| Duration of hospitalization | Up to 29 days |
| Adverse events | Up to 180 days |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020164 | Chemical Actions and Uses |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |