Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.
Description: An 8 point ordinal scale will be used to assess pulmonary status consisting of the following values: 8= Death; 7= Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min); 6= Intubation and mechanical ventilation; 5= Non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4= Oxygen by mask or nasal prongs; 3= Hospitalization without oxygen supplementation; 2= Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility (+/- supplemental oxygen); 1= Discharged to home without supplemental oxygen
Measure: Change in pulmonary status Time: baseline, through study completion, an average of 45 daysDescription: number of events
Measure: Incidence of serious adverse events Time: baseline, through study completion, an average of 45 daysDescription: When calculating days of hospitalization, re-hospitalization or death occurring in the first 28 days should result in zero ascribed to time out of the hospital prior to readmission.
Measure: Length of hospitalization Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 daysDescription: Reintubations or death within 28 days will result in zero ascribed time off ventilator prior to reintubation
Measure: Ventilator free days Time: baseline, through study completion, an average of 45 days