COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes
substantial morbidity and mortality. Nosocomial acquisition of SARS-CoV-2 is a frequent
concern across hospital settings in Canada and is associated with substantial morbidity and
mortality. This clinical trial is initially designed to evaluate the role of monoclonal
antibodies against the SARS-CoV-2 spike protein, for the treatment of hospitalized patients
who acquire COVID19 via nosocomial infection. New treatments, as they become available, may
be integrated, with appropriate adaptation of this document. The trial was initiated with the
bamlanivimab product with the options of casirivimab/imdesimab and sotrovimab added as the
prevalence of bamlanivimab resistant variants of concerns increased.
It is believed that monoclonal antibody treatments are most likely to be effective early in
the disease course. The ability to rapidly identify and initiate such treatments in patients
with nosocomial acquisition of the infection, combined with the high mortality of 25-30%
experienced by this group of patients led us to propose this trial in collaboration with the
CATCO national network.
The overall objective of the study is to evaluate the safety and clinical effectiveness of
anti-SARS-CoV-2 monoclonal antibody treatment relative to the control arm, in patients who
develop nosocomial SARS-CoV-2 infection, on need for mechanical ventilation or death.
This study is designed as a pragmatic randomized, open-label, controlled clinical trial.
Subjects will be randomized to receive either standard-of-care (control) or the study
medication on a 1:2 basis. Bamlanivimab, casirivimab/imdesimab or sotrovimab will be
administered intravenously as a one-time infusion after randomization. Casirivimab/imdesimab
(REGN) and sotrovimab will be the default agents based on local availability unless both are
unavailable AND virus strain known to be native or alpha (B.1.1.7). Incidence of
infusion-related reactions in the 24 hours post administration.