RE: At Home Trial21 Jan 2021 07:35
Mac, The SG016 does not have death as a primary or secondary endpoint. The endpoints for the trial are below and this is what they are looking at statistical significance in. They didn't look at death as an endpoint in the hospital trial and will not be looking at it in the home trial either.
Primary endpoint
• Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period.
Secondary Endpoints
• Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present
at time of enrolment
• Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at
time of enrolment
• Time to clinical resolution =4 of 5 vital signs (temperature, O2 sats, Resp
rate, heart rate, systolic blood pressure).
• LRT Symptoms (Changes in daily symptoms breathlessness, cough and sputum scale
(BCSS) symptoms score during the study period (including disaggregated scores))
• Virus clearance/load
• Safety and tolerability
• Blood and sputum biomarkers if samples are available