Non-inferiority Trial on Treatments in Early COVID-19
Status:
Recruiting
Trial end date:
2022-10-30
Target enrollment:
Participant gender:
Summary
The study aims at assessing the non-inferiority of tixagevimab plus cilgavimab and
nirmatrelvir plus ritornavir vs. sotrovimab (reference standard due to the wider evidence
gathered on its efficacy) on COVID-19 progression in a real-life setting of outpatients aged
at least 50 years at an early stage of the disease. The progression of COVID-19 disease
(hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of
randomisation is the composite outcome variable on which the calculation of the sample size
is based. Based on available data regarding the reduction in the number of hospitalisations
and medical visits with the use of sotrovimab at an early-stage of COVID-19, a disease
progression of 1% has been estimated in the reference arm. 3% delta margin was considered
clinically relevant, taking into account both the estimates of disease progression in the
study population in absence of early treatment (7%, based on national data) and the efficacy
of the reference standard. Therefore, 1095 participants will be randomly assigned in an equal
ratio between the reference standard and each of the other two experimental arms (1:1:1).
Randomization will be computer-generated in permuted blocks with a stratification based on
site.