CATCO-NOS: Treatment of Nosocomial COVID-19

Sponsor

University of Calgary (Other)

Overall Status

Suspended

CT.gov ID

NCT04748588

Collaborator

Sunnybrook Research Institute (Other)

648

Enrollment

Locations

Arms

25.5

Anticipated Duration (Months)

162

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Nosocomial Infection SARS-CoV2 Infection	Drug: Anti-SARS-CoV-2 mAb	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

648 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2021

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care
Experimental: Anti SARS-CoV-2 monoclonal antibody Single IV administration of an anti-SARS-CoV-2 Monoclonal antibody	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. Other Names: casirivimab/imdesimab, bamlanivimab, sotrovimab

Arm

Intervention/Treatment

No Intervention: Standard of care

Experimental: Anti SARS-CoV-2 monoclonal antibody

Single IV administration of an anti-SARS-CoV-2 Monoclonal antibody

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.

Other Names:

casirivimab/imdesimab, bamlanivimab, sotrovimab

Outcome Measures

Primary Outcome Measures

Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge [Length of hospitalization or 60 days]

Secondary Outcome Measures

In-hospital death [60 days]
Need for mechanical ventilation [60 days]
Need for new intensive care admission [60 days]
Need for new oxygen administration [60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N1N4
2	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7
3	Hôpital Montfort	Ottawa	Ontario	Canada	K1K0T2
4	Michael Garron Hospital	Toronto	Ontario	Canada	M4C3E7