2.4.2. Efficacy End Point
COVID-19-related death, confusion, SARS-CoV-2 infection, death, fever, fatigue, diarrhea, COVID-19 infection, cough, Death, headache, nausea,, runny nose, aches, shortness of breath
SARS-COV-2 INFECTION, ASYMPTOMATIC SARS-COV-2 INFECTION, DISEASE, LOSS OF APPETITE, COVID-19 INFECTION, SYMPTOMATIC COVID-19
The primary efficacy end point was the occurrence of any of the following COVID-19-related outcomes:Asymptomatic SARS-CoV-2 infection: SARS-CoV-2 infection verified by either a molecular or antigen test.Symptomatic COVID-19 disease: SARS-CoV-2 infection confirmed by a molecular or antigen test and at least one of the following symptoms at the time of testing: fever, shortness of breath, difficulty breathing, new-onset confusion (only for participants ≥60 years), loss of appetite or decrease in food intake (only for participants ≥60 years on baseline supplemental oxygen), cough, fatigue, headache, body aches, runny nose, nausea, vomiting, and diarrhea.COVID-19-related hospitalization: Patients with a recorded COVID-19 infection who required hospitalization due to the COVID-19 infection.ICU admission for COVID-19: An ICU admission or discharge note indicating that COVID-19 was the patient’s primary diagnosis.COVID-19-related death: Death certificates indicating that COVID-19 was a contributing factor in the decedent’s passing; hospitalization and subsequent death with COVID-19 indicated as the primary diagnosis; or death within 28 days of a COVID-19 diagnosis and hospitalization.