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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.
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 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).
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Clinical status of subject at day 15 (on a 7 point ordinal scale).
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Time frame: Up to 15 days
Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Time frame: 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.
Time frame: Up to 29 days
Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29
Time frame: Up to 29 days
Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment
Time frame: 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
Time frame: Up to 29 days
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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.
Cause of death (if applicable)
Time frame: Up to 24 weeks
Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)
Time frame: 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
Time frame: 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.
Time frame: Up to 29 days
Duration of supplemental oxygen (if applicable)
Time frame: Up to 29 days
Duration of mechanical ventilation (if applicable)
Time frame: Up to 29 days
Duration of hospitalization
Time frame: Up to 29 days
Adverse events
Time frame: Up to 180 days