Status:
UNKNOWN
Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
AbbVie
Apotex Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hospit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 18 2024
Estimated Enrollment :
2900 Patients enrolled
Trial Details
Trial ID
NCT04330690
Start Date
March 18 2020
End Date
May 18 2024
Last Update
October 13 2023
Active Locations (53)
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1
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
2
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
3
Rockyview General Hospital
Calgary, Alberta, Canada, T2V 1P9
4
South Health Campus
Calgary, Alberta, Canada, T3M 1M4