Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial
NCT ID: NCT04330690
Last Updated: 2023-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2900 participants
INTERVENTIONAL
2020-03-18
2024-05-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Artesunate
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
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
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Imatinib
400 mg enterally daily for 14 days plus standard of care
Infliximab
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Infliximab
5 mg/kg IV given one time, over 2 hours plus standard of care
Dexamethasone
Subjects will be randomized between Dexamethasone vs 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
Subjects will be randomized between LSALT vs standard of care.
LSALT Peptide
5 mg , 2 hour IV infusion once daily for up to 14 consecutive days
Control (Standard Care)
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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:
1. On 10 days of steroid course and
2. Receiving any supplemental oxygen for 10 days
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Apotex Inc.
INDUSTRY
World Health Organization
OTHER
University of British Columbia
OTHER
Arch Biopartners Inc.
INDUSTRY
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Srinivas Murthy, MD
Role: PRINCIPAL_INVESTIGATOR
Provincial Health Services Authority
Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
Rockyview General Hospital
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Misericordia Community Hospital
Edmonton, Alberta, Canada
University of Alberta Hopsital
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Interior Health Royal Inland Hospital
Kamloops, British Columbia, Canada
Lions Gate Hospital
North Vancouver, British Columbia, Canada
Richmond Hospital
Richmond, British Columbia, Canada
Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia
Vancouver, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
Island Health - Royal Jubilee Hospital
Victoria, British Columbia, Canada
Island Health - Victoria General Hospital
Victoria, British Columbia, Canada
Island Health - Nanaimo Regional General Hospital
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Grace General Hospital
Winnipeg, Manitoba, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, 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
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hôpital Montfort
Ottawa, Ontario, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Queensway Carleton Hospital
Ottawa, Ontario, Canada
Scarborough Health Network - Centenary Hospital
Scarborough Village, Ontario, Canada
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, Canada
Scarborough Health Network - Birchmount Hospital
Scarborough Village, Ontario, Canada
Niagara Health
St. Catharines, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Unity Health Toronto - St. Joseph's Health Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre-Glen Site Royal Victoria Hospital
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
Québec, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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References
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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.
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, 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.
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.
Grundeis 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.
Lau 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.
Essai 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.
Ansems 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.
Related Links
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Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial
Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results
Other Identifiers
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2114
Identifier Type: -
Identifier Source: org_study_id
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