Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)

Sunnybrook Health Sciences Centre

Status and phase: Active, not recruiting; Phase 3

Conditions: COVID-19

Treatments: Drug: Imatinib; Drug: Artesunate; Drug: Infliximab; Drug: LSALT Peptide; Drug: Dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04330690

2114

Details and patient eligibility

About

This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.

Full 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.

Enrollment: 2,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Each participant must meet all of the following inclusion criteria to participate in this study:

1. ≥ 18 years of age
2. 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.
3. Hospitalized at a participating centre
4. Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection
5. 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

1. On 10 days of steroid course and
2. 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:

1. Anticipated transfer to another hospital, within 72 hours, which is not a study site
2. Expected to not survive beyond 24 hours
3. 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:

1. Pregnant or breastfeeding;
2. Known hypersensitivity to imatinib;
3. Liver transaminases (either ALT or AST) > 5x upper limit of normal

Infliximab:

1. Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV
2. Known or suspected active tuberculosis
3. Known hypersensitivity to infliximab

Randomization LSALT:

1. Known hypersensitivity or prior use of LSALT peptide.
2. Pregnant or breastfeeding

Randomization Dex:

1. Receiving glucocorticoids for a specific, non-COVID-19 indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,900 participants in 6 patient groups

Artesunate

Experimental group

Description:

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Treatment:

Drug: Artesunate

Imatinib

Experimental group

Description:

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Treatment:

Drug: Imatinib

Infliximab

Experimental group

Description:

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Treatment:

Drug: Infliximab

Dexamethasone

Experimental group

Description:

Subjects will be randomized between Dexamethasone vs standard of care.

Treatment:

Drug: Dexamethasone

LSALT Peptide

Experimental group

Description:

Subjects will be randomized between LSALT vs standard of care.

Treatment:

Drug: LSALT Peptide

Control (Standard Care)

No Intervention group

Description:

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.