Treatment of Nosocomial COVID-19

Summary

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.

Conditions

• Covid19
• Nosocomial Infection
• SARS-CoV2 Infection

Interventions

DRUG

Anti-SARS-CoV-2 mAb

Casirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1. Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents used (according to local availability) unless both unavailable AND virus strain known to be native or alpha (B.1.1.7) in which case bamlanivimab can be used.

Sponsors & Collaborators

• Sunnybrook Research Institute

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Alain Tremblay · University of Calgary

• Robert Fowler · University of Toronto

• Srinivas Murthy · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-12

Primary Completion

2022-01-31

Completion

2022-01-31

Countries

• Canada

Study Locations