A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)
Overview
- Phase
- Phase 3
- Intervention
- Artesunate
- Conditions
- COVID-19
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 2900
- Locations
- 53
- Primary Endpoint
- Randomization WHO- Mortality
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
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:
- •Known hypersensitivity to artesunate
- •Pregnant or breastfeeding;
Arms & Interventions
Artesunate
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Intervention: Artesunate
Imatinib
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Intervention: Imatinib
Infliximab
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Intervention: Infliximab
Dexamethasone
Subjects will be randomized between Dexamethasone vs standard of care.
Intervention: Dexamethasone
LSALT Peptide
Subjects will be randomized between LSALT vs standard of care.
Intervention: LSALT Peptide
Outcomes
Primary Outcomes
Randomization WHO- Mortality
Time Frame: 28 days
All-cause mortality, assessed at hospital discharge.
Randomization LSALT- Respiratory support
Time Frame: 28 days
Number of days respiratory support free days
Randomization Dex- Clinical Status
Time Frame: 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 Outcomes
- 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)
- Evaluation of the clinical effectiveness of study drugs(24 months)
- Need for invasive mechanical ventilation(24 months)