Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04330690
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.
- Detailed Description
Subjects will be randomized, across one, two, three or up to four separate randomizations, to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.
Randomization WHO: Imatinib vs Infliximab vs Artesunate vs Standard of care
Randomization Dex: Dexamethasone vs Standard of care
Randomization LSALT: LSALT Peptide vs Standard of care
Hospitalized subjects will require blood sampling for screening and on days 1 and 5.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2900
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
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:
- 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:
- Receiving glucocorticoids for a specific, non-COVID-19 indication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LSALT Peptide LSALT Peptide Subjects will be randomized between LSALT vs standard of care. Artesunate Artesunate Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care Imatinib Imatinib Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care Infliximab Infliximab Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care Dexamethasone Dexamethasone Subjects will be randomized between Dexamethasone vs standard of care.
- Primary Outcome Measures
Name Time Method Randomization LSALT- Respiratory support 28 days Number of days respiratory support free days
Randomization WHO- Mortality 28 days All-cause mortality, assessed at hospital discharge.
Randomization Dex- Clinical Status 28 days Position on the WHO Ordinal scale at 28 days post-randomization.
Ordinal Scale Table:
0 Uninfected; 1-3 Ambulatory; 4-5 Hospitalized/ Mild disease; 6-9 Hospitalized/ Severe Disease; 10 Death
- Secondary Outcome Measures
Name Time Method CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT 24 months Mortality 12 months Mortality after Randomization
Evaluation of the clinical effectiveness of study drugs 24 months To be compared to the control arm on duration of hospitalization
Need for invasive mechanical ventilation 24 months
Trial Locations
- Locations (53)
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Trillium Health Partners -Mississauga Site
🇨🇦Mississauga, Ontario, Canada
Grey Nuns Community Hospital
🇨🇦Edmonton, Alberta, Canada
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Grace General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Michael Garron Hospital
🇨🇦Toronto, Ontario, Canada
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
CHU de Québec - Université Laval
🇨🇦Québec, Quebec, Canada
Victoria Hospital
🇨🇦London, Ontario, Canada
William Osler Health System - Etobicoke General Hospital
🇨🇦Etobicoke, Ontario, Canada
Scarborough Health Network - General Hospital
🇨🇦Scarborough, Ontario, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Niagara Health
🇨🇦Saint Catharines, Ontario, Canada
Humber River Hospital
🇨🇦Toronto, Ontario, Canada
St.Joseph's Health Care
🇨🇦London, Ontario, Canada
Queensway Carleton Hospital
🇨🇦Ottawa, Ontario, Canada
Scarborough Health Network - Birchmount Hospital
🇨🇦Scarborough, Ontario, Canada
Trillium Health Partners-Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Hôpital Montfort
🇨🇦Ottawa, Ontario, Canada
Scarborough Health Network - Centenary Hospital
🇨🇦Scarborough, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
William Osler Health System - Brampton Civic Hospital
🇨🇦Brampton, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre-Glen Site Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Richmond Hospital
🇨🇦Richmond, British Columbia, Canada
Island Health - Nanaimo Regional General Hospital
🇨🇦Victoria, British Columbia, Canada
Rockyview General Hospital
🇨🇦Calgary, Alberta, Canada
Misericordia Community Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Lions Gate Hospital
🇨🇦North Vancouver, British Columbia, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
🇨🇦Québec, Quebec, Canada
Island Health - Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
University of Alberta Hopsital
🇨🇦Edmonton, Alberta, Canada
Interior Health Royal Inland Hospital
🇨🇦Kamloops, British Columbia, Canada
Eastern Regional Health Authority
🇨🇦Saint John's, Newfoundland and Labrador, Canada
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
South Health Campus
🇨🇦Calgary, Alberta, Canada
Island Health - Victoria General Hospital
🇨🇦Victoria, British Columbia, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Unity Health Toronto - St. Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada
University Hospital
🇨🇦London, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada