Treatment of Nosocomial COVID-19

Covid19 Clinical Trial

— CATCO-NOS  

Official title:

Canadian Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of Nosocomial Acquired COVID-19 Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04748588
• Other study ID #: REB21-0096
• Status: Terminated
• Phase: Phase 4
• Start date: February 12, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay, in any specimen prior to randomization.

• Admitted to a participating centre

• Is nosocomially acquired infection, as defined by ALL of:

• COVID19 diagnosis being made on admission day three or later;

• Admitted for a reason other than COVID19;

• Within 5 days of COVID19 diagnosis based on test collection date or initial development of symptoms, which ever was earliest.

Exclusion Criteria:

• Plan for palliation within 24 hours

• Known allergy to study medication or its components (non-medicinal ingredients)

• Ordinal scale 6 or above

• Admitted to facility for non-medical reasons including primary psychiatric diagnosis or labour and delivery.

• Pregnancy or breast feeding

• Weight less than 40kg

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Cross Infection
• Infections
• Nosocomial Infection
• SARS-CoV2 Infection

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Hôpital Montfort	Ottawa	Ontario
Canada	Michael Garron Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Sunnybrook Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge		Length of hospitalization or 60 days
Secondary	In-hospital death		60 days
Secondary	Need for mechanical ventilation		60 days
Secondary	Need for new intensive care admission		60 days
Secondary	Need for new oxygen administration		60 days