Non-inferiority Trial on Monoclonal Antibodies in COVID-19
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use
Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate
COVID-19 in non hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are
at high risk for progressing to severe disease and/or hospitalization (bamlanivimab plus
etesevimab, sotrovimab, and casirivimab plus imdevimab). The study aims at assessing the
non-inferiority of bamlanivimab plus etesevimab and sotrovimab vs. casirivimab plus imdevimab
(reference standard due to the wider evidence gathered on its efficacy) on COVID-19
progression in patients 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 casirivimab plus imdevimab
at an early-stage of COVID-19, a disease progression of 5% has been estimated in the
reference arm. 5% delta margin was considered clinically relevant, taking into account both
the estimates of disease progression in the study population in absence of early treatment
with monoclonal antibodies (20%, based on national data) and the efficacy of the reference
standard. Therefore, 1260 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.