Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748588
Status:
TERMINATED
Last Update Posted:
2023-04-19
First Post:
2021-02-08
Brief Title:
Treatment of Nosocomial COVID-19
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Canadian Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of Nosocomial Acquired COVID-19 Patients
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Equipoise requirement no longer met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATCO-NOS
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 casirivimabimdesimab 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 12 basis Bamlanivimab casirivimabimdesimab or sotrovimab will be administered intravenously as a one-time infusion after randomization Casirivimabimdesimab 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 B117 Incidence of infusion-related reactions in the 24 hours post administration
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 12 basis Bamlanivimab casirivimabimdesimab or sotrovimab will be administered intravenously as a one-time infusion after randomization Casirivimabimdesimab 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 B117 Incidence of infusion-related reactions in the 24 hours post administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None