Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Artesunate, Infliximab, Imatinib, Dexamethasone, SARS-CoV-2, LSALT Peptide
Eligibility Criteria
Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to participate in this study:
- ≥ 18 years of age
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen, within 14 days prior to randomization.
- Hospitalized at a participating centre
- Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection
- First admission for acute COVID19
In addition, there will be the below intervention-specific inclusion:
Randomization WHO will have no other specific inclusion criteria.
Randomization LSALT will have no other specific inclusion criteria.
Randomization Dex will have the following specific inclusion criteria
- On 10 days of steroid course and
- Receiving any supplemental oxygen for 10 days
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- Anticipated transfer to another hospital, within 72 hours, which is not a study site
- Expected to not survive beyond 24 hours
- Receiving one of the study drugs at time of enrolment
In addition, there will be the below intervention-specific exclusions:
Randomization WHO:
These will be drug-specific exclusions; patients will still be eligible for randomization in Randomization WHO to the other available study drugs (in randomization WHO or subsequent randomizations).
Artesunate:
1. Known hypersensitivity to artesunate
Imatinib:
- Pregnant or breastfeeding;
- Known hypersensitivity to imatinib;
- Liver transaminases (either ALT or AST) > 5x upper limit of normal
Infliximab:
- Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV
- Known or suspected active tuberculosis
- Known hypersensitivity to infliximab
Randomization LSALT:
- Known hypersensitivity or prior use of LSALT peptide.
- Pregnant or breastfeeding
Randomization Dex:
1. Receiving glucocorticoids for a specific, non-COVID-19 indication
Sites / Locations
- Peter Lougheed Centre
- Foothills Medical Centre
- Rockyview General Hospital
- South Health Campus
- Royal Alexandra Hospital
- Misericordia Community Hospital
- University of Alberta Hopsital
- Grey Nuns Community Hospital
- Interior Health Royal Inland Hospital
- Lions Gate Hospital
- Richmond Hospital
- Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia
- St Paul's Hospital
- Island Health - Royal Jubilee Hospital
- Island Health - Victoria General Hospital
- Island Health - Nanaimo Regional General Hospital
- St. Boniface Hospital
- Health Sciences Centre
- Grace General Hospital
- Eastern Regional Health Authority
- Nova Scotia Health Authority
- Royal Victoria Regional Health Centre
- William Osler Health System - Brampton Civic Hospital
- William Osler Health System - Etobicoke General Hospital
- St. Joseph's Healthcare Hamilton
- St.Joseph's Health Care
- University Hospital
- Victoria Hospital
- Markham Stouffville Hospital
- Trillium Health Partners -Mississauga Site
- Trillium Health Partners-Credit Valley Hospital
- The Ottawa Hospital - General Campus
- Hôpital Montfort
- The Ottawa Hospital - Civic Campus
- Queensway Carleton Hospital
- Niagara Health
- Scarborough Health Network - Centenary Hospital
- Scarborough Health Network - General Hospital
- Scarborough Health Network - Birchmount Hospital
- Thunder Bay Regional Health Sciences Centre
- North York General Hospital
- Humber River Hospital
- Michael Garron Hospital
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- Mount Sinai Hospital
- Toronto Western Hospital
- Unity Health Toronto - St. Joseph's Health Centre
- Centre Hospitalier de l'Université de Montréal (CHUM)
- McGill University Health Centre-Glen Site Royal Victoria Hospital
- CHU de Québec - Université Laval
- Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
- Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Artesunate
Imatinib
Infliximab
Dexamethasone
LSALT Peptide
Control (Standard Care)
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Subjects will be randomized between Dexamethasone vs standard of care.
Subjects will be randomized between LSALT vs standard of care.
This arm will receive standard supportive care guidelines for COVID-19. It is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.