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

COVID-19 Clinical Trial

— CATCO  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04330690
• Other study ID #: 2114
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 18, 2020
• Est. completion date: May 18, 2024

Study information

• Verified date: January 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2900
• Est. completion date: May 18, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Artesunate
2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care
• Imatinib
400 mg enterally daily for 14 days plus standard of care
• Infliximab
5 mg/kg IV given one time, over 2 hours plus standard of care
• Dexamethasone
6 mg IV/oral for a further five days, followed by a five day taper of 4 mg x 2 days and 2 mg x 3 days, for a total 20 day steroid course. If randomized to standard of care, discontinue the corticosteroid on day 10
• LSALT Peptide
5 mg , 2 hour IV infusion once daily for up to 14 consecutive days

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	William Osler Health System - Brampton Civic Hospital	Brampton	Ontario
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	Rockyview General Hospital	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Misericordia Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hopsital	Edmonton	Alberta
Canada	William Osler Health System - Etobicoke General Hospital	Etobicoke	Ontario
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Interior Health Royal Inland Hospital	Kamloops	British Columbia
Canada	St.Joseph's Health Care	London	Ontario
Canada	University Hospital	London	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Trillium Health Partners -Mississauga Site	Mississauga	Ontario
Canada	Trillium Health Partners-Credit Valley Hospital	Mississauga	Ontario
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	McGill University Health Centre-Glen Site Royal Victoria Hospital	Montréal	Quebec
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Hôpital Montfort	Ottawa	Ontario
Canada	Queensway Carleton Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval	Québec	Quebec
Canada	Richmond Hospital	Richmond	British Columbia
Canada	Niagara Health	Saint Catharines	Ontario
Canada	Eastern Regional Health Authority	Saint John's	Newfoundland and Labrador
Canada	Scarborough Health Network - Birchmount Hospital	Scarborough	Ontario
Canada	Scarborough Health Network - Centenary Hospital	Scarborough	Ontario
Canada	Scarborough Health Network - General Hospital	Scarborough	Ontario
Canada	Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	Michael Garron Hospital	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Unity Health Toronto - St. Joseph's Health Centre	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia	Vancouver	British Columbia
Canada	Island Health - Nanaimo Regional General Hospital	Victoria	British Columbia
Canada	Island Health - Royal Jubilee Hospital	Victoria	British Columbia
Canada	Island Health - Victoria General Hospital	Victoria	British Columbia
Canada	Grace General Hospital	Winnipeg	Manitoba
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (6)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	AbbVie, Apotex Inc., Arch Biopartners Inc., University of British Columbia, World Health Organization

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Ali K, Azher T, Baqi M, Binnie A, Borgia S, Carrier FM, Cavayas YA, Chagnon N, Cheng MP, Conly J, Costiniuk C, Daley P, Daneman N, Douglas J, Downey C, Duan E, Duceppe E, Durand M, English S, Farjou G, Fera E, Fontela P, Fowler R, Fralick M, Geagea A, Gra — View Citation

Cheng M, Fowler R, Murthy S, Pinto R, Sheehan NL, Tseng A. Remdesivir in Patients With Severe Kidney Dysfunction: A Secondary Analysis of the CATCO Randomized Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2229236. doi: 10.1001/jamanetworkopen.2022.29236. — View Citation

WHO Solidarity Trial Consortium; Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernandez Garcia C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Randomization WHO- Mortality	All-cause mortality, assessed at hospital discharge.	28 days
Primary	Randomization Dex- Clinical Status	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	28 days
Primary	Randomization LSALT- Respiratory support	Number of days respiratory support free days	28 days
Secondary	Evaluation of the clinical effectiveness of study drugs	To be compared to the control arm on duration of hospitalization	24 months
Secondary	Need for invasive mechanical ventilation		24 months
Secondary	CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT		24 months
Secondary	Mortality	Mortality after Randomization	12 months

External Links

•   Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial
•   Remdesivir in Patients With Severe Kidney Dysfunction. A Secondary Analysis of the CATCO Randomized Trial
•   Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results