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

  • STATUS
    Recruiting
  • End date
    May 18, 2024
  • participants needed
    2900
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 4 October 2022
Investigator
Laura Genge
Primary Contact
Eastern Regional Health Authority (1.6 mi away) Contact
+44 other location
lopinavir/ritonavir
covid-19
SARS
remdesivir
hydroxychloroquine

Summary

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

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 ARBs: ARBs 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. For participants randomized to Randomization 2 arm, research blood will be collected on baseline, Days 2, 4, 7 and 14, and in follow-up on 1, 3 and 6 month if hospitalized.

Details
Condition COVID-19
Treatment Lopinavir/Ritonavir, Dexamethasone, Infliximab, Imatinib, losartan, hydroxychloroquine, Interferon beta-1a, Artesunate, Remdesivir, LSALT peptide, ARBs
Clinical Study IdentifierNCT04330690
SponsorSunnybrook Health Sciences Centre
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Each participant must meet all of the following inclusion criteria to participate in this
study
≥ 18 years of age
Hospitalized at a participating centre
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
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 ARBs 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

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
All participants meeting any of the following exclusion criteria at baseline will be
excluded from participation in this study
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 ARBs
Hypotension (SAP < 100 mmHg or DAP < 50 mmHg or MAP < 65 mmHg)
Hyperkalemia (> 5.5 mmol/L)
Acute kidney injury (urine output < 0.5 ml/kg/hr and new creatinine > 200 µmol/l, or
increase > 100 µmol/l from baseline creatinine, or GFR < 30 ml/min)
Use of ARB/ACEi within 7 days of presentation (because randomization to usual care and
stopping ARB/ACEi risks complications)
Pregnant or breastfeeding - A negative pregnancy test for women of child bearing
potential
Have a known allergy to ARBs or any component of the drug product
Have written legal document to withhold life-sustaining treatments (patients not
wishing to receive Cardiopulmonary Resuscitation (CPR) can participate if other
medical treatments will be given)
Have signed a Do No Resuscitate (DNR) Form
Use of aliskiren in patients with diabetes mellitus (type 1 or type 2) or
moderate-severe renal impairment (GFR less than 60mL/min)
Randomization LSALT
Known hypersensitivity or prior use of LSALT peptide
Pregnant or breastfeeding
Randomization Dex
Receiving glucocorticoids for a specific, non-COVID-19 indication
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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