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COVID-19Phase 3CATCONCT04330690

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

A Phase 3 study testing Artesunate, Imatinib and Infliximab in people with COVID-19, run by Sunnybrook Health Sciences Centre at 53 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Artesunate, Imatinib and Infliximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,900 participants
Where
53 sitesCanada
Study dates
18 Mar 2020to 18 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each participant must meet all of the following inclusion criteria to participate in this study:
  • ≥ 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
Show all 12Show fewer
  • 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
  • On 10 days of steroid course and
  • Receiving any supplemental oxygen for 10 days

Who cannot join

  • All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
  • 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
  • In addition, there will be the below intervention-specific exclusions:
  • Randomization WHO:
Show all 22Show fewer
  • 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:
  • 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:
  • Known hypersensitivity or prior use of LSALT peptide.
  • Pregnant or breastfeeding
  • Randomization Dex:
  • 1. Receiving glucocorticoids for a specific, non-COVID-19 indication

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Canada53 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

  • South Health Campus

    Calgary, Alberta, T3M 1M4

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5K0L4

  • Misericordia Community Hospital

    Edmonton, Alberta, T5R 4H5

  • University of Alberta Hopsital

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8

  • William Osler Health System - Etobicoke General Hospital

    Etobicoke, Ontario, M9V 1R8

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3S 0H6

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Interior Health Royal Inland Hospital

    Kamloops, British Columbia, V2C2T1

  • St.Joseph's Health Care

    London, Ontario, N6A 4V2

  • University Hospital

    London, Ontario, N6A 5A5

  • Victoria Hospital

    London, Ontario, N6A 5W9

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7P3

  • Trillium Health Partners -Mississauga Site

    Mississauga, Ontario, L5B 1B8

  • Trillium Health Partners-Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre-Glen Site Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Hôpital Montfort

    Ottawa, Ontario, K1K 0T2

  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Queensway Carleton Hospital

    Ottawa, Ontario, K2H 8P4

  • CHU de Québec - Université Laval

    Québec, Quebec, G1J 1Z4

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval

    Québec, Quebec, G1V 4G5

  • Richmond Hospital

    Richmond, British Columbia, V6X 1A2

  • Niagara Health

    Saint Catharines, Ontario, L2S 0A9

  • Scarborough Health Network - Centenary Hospital

    Scarborough Village, Ontario, M1E4B9

  • Scarborough Health Network - General Hospital

    Scarborough Village, Ontario, M1P2V5

  • Scarborough Health Network - Birchmount Hospital

    Scarborough Village, Ontario, M1W3W3

  • Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Eastern Regional Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Michael Garron Hospital

    Toronto, Ontario, M4C 3E7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Toronto Western Hospital

    Toronto, Ontario, M5T2S8

  • Unity Health Toronto - St. Joseph's Health Centre

    Toronto, Ontario, M6R1B5

  • Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia

    Vancouver, British Columbia, V5Z1M9

  • St Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Island Health - Royal Jubilee Hospital

    Victoria, British Columbia, V8R 1J8

  • Island Health - Victoria General Hospital

    Victoria, British Columbia, V8Z 6R5

  • Island Health - Nanaimo Regional General Hospital

    Victoria, British Columbia, V9S 2B7

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

  • Grace General Hospital

    Winnipeg, Manitoba, R3J 3M7

Other trials in Canada

About this study

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)

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

Read the detailed 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.

Conditions
COVID-19
Being tested
Artesunate, Imatinib, Infliximab, Dexamethasone, LSALT Peptide
Keywords
Artesunate, Infliximab, Imatinib, Dexamethasone, SARS-CoV-2, LSALT Peptide
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArtesunateDrug

    2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care

  • ImatinibDrug

    400 mg enterally daily for 14 days plus standard of care

  • InfliximabDrug

    5 mg/kg IV given one time, over 2 hours plus standard of care

  • DexamethasoneDrug

    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 PeptideDrug

    5 mg , 2 hour IV infusion once daily for up to 14 consecutive days

Study groups in NCT04330690
Study groupRoleWhat they receive
ArtesunateExperimentalSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Receives: Drug: Artesunate
ImatinibExperimentalSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Receives: Drug: Imatinib
InfliximabExperimentalSubjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Receives: Drug: Infliximab
DexamethasoneExperimentalSubjects will be randomized between Dexamethasone vs standard of care.
Receives: Drug: Dexamethasone
LSALT PeptideExperimentalSubjects will be randomized between LSALT vs standard of care.
Receives: Drug: LSALT Peptide
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomization WHO- Mortality

    All-cause mortality, assessed at hospital discharge.

    Measured: 28 days

  2. 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

    Measured: 28 days

  3. Randomization LSALT- Respiratory support

    Number of days respiratory support free days

    Measured: 28 days

Secondary outcomes (4)

  1. Evaluation of the clinical effectiveness of study drugs

    To be compared to the control arm on duration of hospitalization

    Measured: 24 months

  2. Need for invasive mechanical ventilation

    Measured: 24 months

  3. CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT

    Measured: 24 months

  4. Mortality

    Mortality after Randomization

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2020
  2. Study start18 Mar 2020
  3. Primary completion10 Mar 2024 (estimated)
  4. Study completion18 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04330690
Sponsor's protocol ID
2114
Acronym
CATCO
Status last verified
Jan 2023
First submitted
23 Mar 2020
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35045989

  • 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.

    PubMed 33264556

  • 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.

    PubMed 36036936

  • 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.

    PubMed 36695483

  • 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.

    PubMed 36199248

  • 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.

    PubMed 35609913

  • 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.

    PubMed 34350582

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Artesunate, Imatinib and Infliximab in people with COVID-19, run by Sunnybrook Health Sciences Centre at 53 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomization WHO- Mortality (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330690, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.

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