Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial
CATCO
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)
1 other identifier
interventional
2,900
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Mar 2020
Longer than P75 for phase_3 covid19
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2020
CompletedFirst Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2024
CompletedOctober 13, 2023
January 1, 2023
4 years
March 23, 2020
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Randomization WHO- Mortality
All-cause mortality, assessed at hospital discharge.
28 days
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
Randomization LSALT- Respiratory support
Number of days respiratory support free days
28 days
Secondary Outcomes (4)
Evaluation of the clinical effectiveness of study drugs
24 months
Need for invasive mechanical ventilation
24 months
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
Study Arms (6)
Artesunate
EXPERIMENTALSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Imatinib
EXPERIMENTALSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Infliximab
EXPERIMENTALSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Dexamethasone
EXPERIMENTALSubjects will be randomized between Dexamethasone vs standard of care.
LSALT Peptide
EXPERIMENTALSubjects will be randomized between LSALT vs standard of care.
Control (Standard Care)
NO INTERVENTIONThis 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.
Interventions
2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care
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
Eligibility Criteria
You may qualify if:
- ≥ 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
- On 10 days of steroid course and
- Receiving any supplemental oxygen for 10 days
You may not qualify if:
- 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
- Randomization WHO:
- 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 LSALT:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- AbbViecollaborator
- Apotex Inc.collaborator
- World Health Organizationcollaborator
- University of British Columbiacollaborator
- Arch Biopartners Inc.collaborator
Study Sites (53)
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Rockyview General Hospital
Calgary, Alberta, T2V 1P9, Canada
South Health Campus
Calgary, Alberta, T3M 1M4, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5K0L4, Canada
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5, Canada
University of Alberta Hopsital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Interior Health Royal Inland Hospital
Kamloops, British Columbia, V2C2T1, Canada
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7, Canada
Richmond Hospital
Richmond, British Columbia, V6X 1A2, Canada
Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia
Vancouver, British Columbia, V5Z1M9, Canada
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Island Health - Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8, Canada
Island Health - Victoria General Hospital
Victoria, British Columbia, V8Z 6R5, Canada
Island Health - Nanaimo Regional General Hospital
Victoria, British Columbia, V9S 2B7, Canada
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Grace General Hospital
Winnipeg, Manitoba, R3J 3M7, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3S 0H6, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
St.Joseph's Health Care
London, Ontario, N6A 4V2, Canada
University Hospital
London, Ontario, N6A 5A5, Canada
Victoria Hospital
London, Ontario, N6A 5W9, Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3, Canada
Trillium Health Partners -Mississauga Site
Mississauga, Ontario, L5B 1B8, Canada
Trillium Health Partners-Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Hôpital Montfort
Ottawa, Ontario, K1K 0T2, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Queensway Carleton Hospital
Ottawa, Ontario, K2H 8P4, Canada
Niagara Health
Saint Catharines, Ontario, L2S 0A9, Canada
Scarborough Health Network - Centenary Hospital
Scarborough Village, Ontario, M1E4B9, Canada
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, M1P2V5, Canada
Scarborough Health Network - Birchmount Hospital
Scarborough Village, Ontario, M1W3W3, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Michael Garron Hospital
Toronto, Ontario, M4C 3E7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
Unity Health Toronto - St. Joseph's Health Centre
Toronto, Ontario, M6R1B5, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
McGill University Health Centre-Glen Site Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
CHU de Québec - Université Laval
Québec, Quebec, G1J 1Z4, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
Québec, Quebec, G1V 4G5, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (7)
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, Grant J, Harrison LB, Havey T, Hoang H, Kelly LE, Keynan Y, Khwaja K, Klein G, Klein M, Kolan C, Kronfli N, Lamontagne F, Lau R, Fralick M, Lee TC, Lee N, Lim R, Longo S, Lostun A, MacIntyre E, Malhame I, Mangof K, McGuinty M, Mergler S, Munan MP, Murthy S, O'Neil C, Ovakim D, Papenburg J, Parhar K, Parvathy SN, Patel C, Perez-Patrigeon S, Pinto R, Rajakumaran S, Rishu A, Roba-Oshin M, Rushton M, Saleem M, Salvadori M, Scherr K, Schwartz K, Semret M, Silverman M, Singh A, Sligl W, Smith S, Somayaji R, Tan DHS, Tobin S, Todd M, Tran TV, Tremblay A, Tsang J, Turgeon A, Vakil E, Weatherald J, Yansouni C, Zarychanski R; Canadian Treatments for COVID-19 (CATCO); Association of Medical Microbiology and Infectious Disease Canada (AMMI) Clinical Research Network and the Canadian Critical Care Trials Group. Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial. CMAJ. 2022 Feb 22;194(7):E242-E251. doi: 10.1503/cmaj.211698. Epub 2022 Jan 19.
PMID: 35045989RESULTWHO 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, Allum E, Alotaibi A, Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, Garcia PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes EP, Perola M, Portoles A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Rottingen JA, Swaminathan S. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med. 2021 Feb 11;384(6):497-511. doi: 10.1056/NEJMoa2023184. Epub 2020 Dec 2.
PMID: 33264556RESULTCheng 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.
PMID: 36036936RESULTGrundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
PMID: 36695483DERIVEDLau VI, Fowler R, Pinto R, Tremblay A, Borgia S, Carrier FM, Cheng MP, Conly J, Costiniuk CT, Daley P, Duan E, Durand M, Fontela PS, Farjou G, Fralick M, Geagea A, Grant J, Keynan Y, Khwaja K, Lee N, Lee TC, Lim R, O'Neil CR, Papenburg J, Semret M, Silverman M, Sligl W, Somayaji R, Tan DHS, Tsang JLY, Weatherald J, Yansouni CP, Zarychanski R, Murthy S; E-CATCO authors, AMMI Clinical Research Network and Canadian Critical Care Trials Group. Cost-effectiveness of remdesivir plus usual care versus usual care alone for hospitalized patients with COVID-19: an economic evaluation as part of the Canadian Treatments for COVID-19 (CATCO) randomized clinical trial. CMAJ Open. 2022 Sep 6;10(3):E807-E817. doi: 10.9778/cmajo.20220077. Print 2022 Jul-Sep.
PMID: 36199248DERIVEDEssai CATCO (Canadian Treatments for COVID-19); pour le Reseau de recherche clinique de l'Association pour la microbiologie medicale et l'infectiologie Canada (AMMI Canada) le Groupe canadien de recherche en soins intensifs (CCCTG). Remdesivir chez les patients hospitalises pour la COVID-19 au Canada: essai clinique randomise et controle. CMAJ. 2022 May 24;194(20):E713-E723. doi: 10.1503/cmaj.211698-f. French.
PMID: 35609913DERIVEDAnsems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
PMID: 34350582DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivas Murthy, MD
Provincial Health Services Authority British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Endpoint assessment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
April 1, 2020
Study Start
March 18, 2020
Primary Completion
March 10, 2024
Study Completion
May 18, 2024
Last Updated
October 13, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Unknown and variable
As per World Health Organization policies on data sharing in a Public Health Emergency, any clinical trial outcome data will be shared at the earliest possible opportunity. In addition, given the nature of this protocol, being performed across regions, the DSMB may access other regions trials, and possibly recommend alterations in study design based on accumulating data, through a centralized data repository being built under the auspices of the World Health Organization. Data Sharing for Secondary Research Data from this study may be used for secondary research. All of the individual subject data collected during the trial will be made available after de-identification through expert determination. The SAP and Analytic Code will also be made available. This data will be available immediately following publication, with no end date, as part of data sharing requirements from journals and funding agencies.