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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)

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Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2023

Print Profile Download Citation

At a glance

  • Drugs Artesunate (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Imatinib (Primary) ; Infliximab (Primary) ; Metablok-Arch Biopartners (Primary) ; Lopinavir/ritonavir
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms CATCO

    • Most Recent Events

    • 12 Oct 2023 Planned primary completion date changed from 18 Mar 2023 to 10 Mar 2024.
    • 12 Oct 2023 Status changed from recruiting to active, no longer recruiting.
    • 26 Apr 2022 Treatments section has been updated to replace Losartan with Angiotensin II receptor blockers. The type of ARB received will be dependent on what is available at the hospitals.

Trial Overview

Purpose

This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization. Subjects will be randomized to receive either standard-of-care products or the study medication plus supportive care, while being hospitalized for COVID-19.
The CATCO trial will include a 320 patient arm to confirm LSALT Peptide (Metablok) safety and efficacy as a treatment for acute lung inflammation for hospitalized COVID-19 patients.

Primary Endpoints

Randomization WHO- Mortality

description: All-cause mortality, assessed at hospital discharge.
time_frame: 28 days

Randomization LSALT- Respiratory support

description: Number of days respiratory support free days
time_frame: 28 days

Randomization ARBs- 28-day Mortality

description: All-cause mortality within the first 28 days post randomization
time_frame: 28 days

Randomization Dex- Clinical Status

description: 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
time_frame: 28 days

Other Endpoints

Evaluation of the clinical effectiveness of study drugs

description: To be compared to the control arm on duration of hospitalization
time_frame: 24 months

Need for invasive mechanical ventilation

time_frame: 24 months

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

time_frame: 24 months

Severe Adverse Events, and 1, 3 and 6 months mortality, laboratory (cardiac pulmonary coagulation, and renal) and clinical evaluation using standardized pre-defined COVID-19 virtual and/or in person follow-up.

time_frame: 24 months

Mortality

description: Mortality after Randomization
time_frame: 12 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 2900

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04330690 ClinicalTrials.gov: US National Institutes of Health
2114 -

Organisations

  • Affiliations AbbVie; Apotex; Arch Biopartners

Trial Dates

  • Initiation Dates

    Actual : 18 Mar 2020

  • Primary Completion Dates

    Planned : 10 Mar 2024

  • End Dates

    Planned : 18 May 2024

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Canada
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ArtesunatePrimary Drug
-
-
DexamethasonePrimary Drug Intravenous
-
DexamethasonePrimary Drug Oral
-
ImatinibPrimary Drug Enteral
-
InfliximabPrimary Drug Intravenous Infusion
Lopinavir/ritonavir Oral Tablet
Metablok-Arch BiopartnersPrimary Drug
-
-

Artesunate

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care 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

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care Drug: 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 Drug: 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. Drug: 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. Drug: 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.

Results

Publications

  1. Ali K, Azher T, Baqi M, Binnie A, Borgia S, Carrier FM, et al. Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial. . CMAJ 2022;.

    PubMed | CrossRef Fulltext

  2. Lepage MA, Rozza N, Kremer R, Grunbaum A. Safety and effectiveness concerns of lopinavir/ritonavir in COVID-19 affected patients: a retrospective series. Clin-Toxicol-(Phila) 2021;59(7):644-647.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Ali K 1 1 -
Azher T 1 - -
Baqi M 1 - -
Binnie A 1 - -
Borgia S 1 - -
Carrier FM 1 - -
Cavayas YA 1 - -
Chagnon N 1 - -
Cheng MP 1 - -
Conly J 1 - -
Costiniuk C 1 - -
Daley P 1 - -
Daneman N 1 - -
Douglas J 1 - -
Downey C 1 - -
Duan E 1 - -
Duceppe E 1 - -
Durand M 1 - -
English S 1 - -
Farjou G 1 - -
Fera E 1 - -
Fontela P 1 - -
Fowler R 1 - -
Fralick M 1 - -
Geagea A 1 - -
Grant J 1 - -
Grunbaum A 1 - 1
Harrison LB 1 - -
Havey T 1 - -
Hoang H 1 - -
Kelly LE 1 - -
Keynan Y 1 - -
Khwaja K 1 - -
Klein G 1 - -
Klein M 1 - -
Kolan C 1 - -
Kremer R 1 - -
Kronfli N 1 - -
Lamontagne F 1 - -
Lau R 1 - -
Lee N 1 - -
Lee TC 1 - -
Lepage MA 1 1 -
Lim R 1 - -
Longo S 1 - -
Lostun A 1 - -
MacIntyre E 1 - -
Malhame I 1 - -
Mangof K 1 - -
McGuinty M 1 - -
Mergler S 1 - -
Munan MP 1 - -
Murthy S 1 - -
O'Neil C 1 - -
Ovakim D 1 - -
Papenburg J 1 - -
Parhar K 1 - -
Parvathy SN 1 - -
Patel C 1 - -
Perez-Patrigeon S 1 - -
Pinto R 1 - -
Rajakumaran S 1 - -
Rishu A 1 - -
Roba-Oshin M 1 - -
Rozza N 1 - -
Rushton M 1 - -
Saleem M 1 - -
Salvadori M 1 - -
Scherr K 1 - -
Schwartz K 1 - -
Semret M 1 - -
Silverman M 1 - -
Singh A 1 - -
Sligl W 1 - -
Smith S 1 - -
Somayaji R 1 - -
Tan DHS 1 - -
Tobin S 1 - -
Todd M 1 - -
Tran TV 1 - -
Tremblay A 1 - -
Tsang J 1 - -
Turgeon A 1 - -
Vakil E 1 - -
Weatherald J 1 - -
Yansouni C 1 - -
Zarychanski R 1 - 1

Trial Centres

Investigators

Download Data (CSV)
Investigator Centre Name Trial Centre Country
Alain Tremblay, MD
(403) 210-3866 atrembla@ucalgary.ca
show details 		Peter Lougheed Centre, South Health Campus Canada
Alexis Turgeon, MD CHU de Québec - Université Laval Canada
Allison Mah, MD Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia Canada
Anna Geagea, MD North York General Hospital Canada
Bryan Coburn
bryan.Coburn@uhn.ca
show details 		Mount Sinai Hospital Canada
Bryan Coburn, MD Toronto Western Hospital Canada
Cathy Robb
crobb@shn.ca
show details 		Scarborough Health Network - Birchmount Hospital, Scarborough Health Network - Centenary Hospital, Scarborough Health Network - General Hospital Canada
Christine Di Marco
705-728-9090 43341 dimarcoc@rvh.on.ca
show details 		Royal Victoria Regional Health Centre Canada
Christine-Nadia christinencompas@montfort.on.ca
613-746-4621 3623 christinencompas@montfort.on.ca
show details 		Hôpital Montfort Canada
Curtis Dumonceaux
cjdumonc@ucalgary.ca
show details 		Foothills Medical Centre Canada
Daniel Ovekim, MD Island Health - Royal Jubilee Hospital, Island Health - Victoria General Hospital Canada
David Bellamare
418-525-4444 66060 David.Bellemare@crchudequebec.ulaval.ca
show details 		CHU de Québec - Université Laval Canada
Dawn Manley
306-220-9076 dawn.manley@usask.ca
show details 		Royal University Hospital Canada
Diana Monaco
905-472-7373 6777 dmonacom@msh.on.ca
show details 		Markham Stouffville Hospital Canada
Dominique Marcoux
819-346-1110 16208 dominique.marcoux.ciussse-chus@ssss.gouv.qc.ca
show details 		Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke Canada
Fiona Auld
250-213-7778 fiona.auld@viha.ca
show details 		Island Health - Nanaimo Regional General Hospital, Island Health - Royal Jubilee Hospital, Island Health - Victoria General Hospital Canada
France Clarke
(905) 522-1155 33633 clarkef@mcmaster.ca
show details 		St. Joseph's Healthcare Hamilton Canada
Francois Lamontagne, MD Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke Canada
Francois Lellouche, MD Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval Canada
Gabriel Loh
604-244-5519 Gabriel.Loh@vch.ca
show details 		Richmond Hospital Canada
Gail Klein
416-480-5632 CATCO@sunnybrook.ca
show details
-
Gary Annable
gary.annable@umanitoba.ca
show details 		St. Boniface Hospital Canada
Irene Watpool
613-737-8899 78724 iwatpool@ohri.ca
show details 		The Ottawa Hospital - General Campus Canada
Jennifer Barchard
Jennifer.barchard@covenanthealth.ca
show details 		Grey Nuns Community Hospital Canada
Jonathan Roger, MSc.
1 438 404 1919 jonathan.roger@mail.mcgill.ca
show details 		McGill University Health Centre-Glen Site Royal Victoria Hospital Canada
Judeline Louis
450-466-5000 2462 judeline.louis.cisssmc16@ssss.gouv.qc.ca
show details 		CISSS de la Montérégie Centre Canada
Kanthi Kavikondala
416 530 6000 4857 kanthi.kavikondala@unityhealth.to
show details 		Unity Health Toronto - St. Joseph's Health Centre Canada
Khrystyna Kushniriuk
416-858-3995 Khrystyna.kushniriuk@unityhealth.to
show details 		St. Michael's Hospital Canada
Kimberly Robertson
780-407-6945 Kimberly.Robertson2@albertahealthservices.ca
show details 		University of Alberta Hopsital Canada
Kristin Krokoszynski
519-749-4370 2664 Kristin.krokoszynski@grhosp.on.ca
show details 		Grand River Hospital Canada
Laith Bustani
613-859-7567 lbustani@qch.on.ca
show details 		Queensway Carleton Hospital Canada
Laura Genge
709-777-6996 laura.genge@easternhealth.ca
show details 		Eastern Regional Health Authority Canada
Laura Oliveira
604 875-4111 64164 laura.oliveira@ubc.ca
show details 		Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia Canada
Leslie Love
604 682-2344 64242 llove@cheos.ubc.ca
show details 		St Paul's Hospital Canada
Lisa Patterson
905-378-4647 44278 Lisa.patterson@niagarahealth.on.ca
show details 		Niagara Health Canada
Lisette Machado
lmachado@ucalgary.ca
show details 		Rockyview General Hospital Canada
Lori Moon
moonl@tbh.net
show details 		Thunder Bay Regional Health Sciences Centre Canada
Maria Kulikova
6475617621 Maria.Kulikova@uhnresearch.ca
show details 		Toronto Western Hospital Canada
Maria Scglag
Maria.Schlag@nygh.on.ca
show details 		North York General Hospital Canada
Matt Munan
7807352858 Matt.Munan@covenanthealth.ca
show details 		Misericordia Community Hospital Canada
Matthew Cheng, MD McGill University Health Centre-Glen Site Royal Victoria Hospital Canada
Meagan Dunn
mkaye@ualberta.ca
show details 		Royal Alexandra Hospital Canada
Michael Silverman, FRCP, FACP, AA HIV Med
(519) 646-6100 61726 Michael.Silverman@sjhc.london.on.ca
show details 		University Hospital, Victoria Hospital Canada
Mobina Khurram
Mobina.Khurram@thp.ca
show details 		Trillium Health Partners -Mississauga Site, Trillium Health Partners-Credit Valley Hospital Canada
Natasha Press, MD St Paul's Hospital Canada
Nelson Lee, MD University of Alberta Hopsital Canada
Patricia Lizotte
418-656-8711 3937 patricia.lizotte@criucpq.ulaval.ca
show details 		Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval Canada
Rebecca Porteous
613-737-8899 17076 rporteous@ohri.ca
show details 		The Ottawa Hospital - Civic Campus Canada
Sanjay Manocha, MD
416-242-1000 77768 SManocha@hrh.ca
show details 		Humber River Hospital Canada
Seema Parvathy
519-646-6100 61726 SeemaNair.Parvathy@sjhc.london.on.ca
show details 		St.Joseph's Health Care Canada
Sergio Borgia
sergio.borgia@williamoslerhs.ca
show details 		William Osler Health System - Brampton Civic Hospital Canada
Shane English, MD The Ottawa Hospital - Civic Campus, The Ottawa Hospital - General Campus Canada
Shaqil Peermohamed, MD Royal University Hospital Canada
Srinivas Murthy, MD
(604) 875-2778 srinivas.murthy@cw.bc.ca
show details
-
Stéphanie Matte
514-816-8153 stephanie.matte.chum@ssss.gouv.qc.ca
show details 		Centre Hospitalier de l'Université de Montréal (CHUM) Canada
Susan John, MD Scarborough Health Network - Birchmount Hospital, Scarborough Health Network - Centenary Hospital, Scarborough Health Network - General Hospital Canada
Thomas Havey
thomas.havey@williamoslerhs.ca
show details 		William Osler Health System - Etobicoke General Hospital Canada
Valla Sahraei
604-988-3131 4934 Valla.sahraei@vch.ca
show details 		Lions Gate Hospital Canada
Vaseeharan Sathiyamoorthy World Health Organization
-
Yoav Keynan, MD
(204) 977-5681 yoav.keynan@umanitoba.ca
show details 		Grace General Hospital Canada

+ Lead investigator

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Centres

Download Data (CSV)
Centre Name Location Trial Centre Country
-
-
-
AbbVie
-
-
Apotex Inc.
-
-
Centre Hospitalier de l'Université de Montréal (CHUM) Montréal, Quebec Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, Quebec Canada
CHU de Québec - Université Laval Québec, Quebec Canada
CISSS de la Montérégie Centre Greenfield Park, Quebec Canada
Eastern Regional Health Authority Saint John's, Newfoundland and Labrador Canada
Foothills Medical Centre Calgary, Alberta Canada
Grace General Hospital Winnipeg, Manitoba Canada
Grand River Hospital Kitchener, Ontario Canada
Grey Nuns Community Hospital Edmonton, Alberta Canada
Humber River Hospital Toronto, Ontario Canada
Hôpital Montfort Ottawa, Ontario Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval Québec, Quebec 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
Lions Gate Hospital North Vancouver, British Columbia Canada
Markham Stouffville Hospital Markham, Ontario Canada
McGill University Health Centre-Glen Site Royal Victoria Hospital Montréal, Quebec Canada
Misericordia Community Hospital Edmonton, Alberta Canada
Mount Sinai Hospital Toronto, Ontario Canada
Niagara Health Saint Catharines, Ontario Canada
North York General Hospital Toronto, Ontario Canada
Peter Lougheed Centre Calgary, Alberta Canada
Queensway Carleton Hospital Ottawa, Ontario Canada
Richmond Hospital Richmond, British Columbia Canada
Rockyview General Hospital Calgary, Alberta Canada
Royal Alexandra Hospital Edmonton, Alberta Canada
Royal University Hospital Saskatoon, Saskatchewan Canada
Royal Victoria Regional Health Centre Barrie, Ontario 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
South Health Campus Calgary, Alberta Canada
St Paul's Hospital Vancouver, British Columbia Canada
St. Boniface Hospital Winnipeg, Manitoba Canada
St. Joseph's Healthcare Hamilton Hamilton, Ontario Canada
St. Michael's Hospital Toronto, Ontario Canada
St.Joseph's Health Care London, Ontario Canada
Sunnybrook Health Sciences Centre Toronto, Ontario Canada
The Ottawa Hospital - Civic Campus Ottawa, Ontario Canada
The Ottawa Hospital - General Campus Ottawa, Ontario Canada
Thunder Bay Regional Health Sciences Centre Thunder Bay, Ontario Canada
Toronto Western Hospital Toronto, Ontario Canada
Trillium Health Partners -Mississauga Site Mississauga, Ontario Canada
Trillium Health Partners-Credit Valley Hospital Mississauga, Ontario Canada
Unity Health Toronto - St. Joseph's Health Centre Toronto, Ontario Canada
University Hospital London, Ontario Canada
University of Alberta Hopsital Edmonton, Alberta Canada
Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia Vancouver, British Columbia Canada
Victoria Hospital London, Ontario Canada
William Osler Health System - Brampton Civic Hospital Brampton, Ontario Canada
William Osler Health System - Etobicoke General Hospital Etobicoke, Ontario Canada
World Health Organization
-
-

+ Lead Centre

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Trial History

Event Date Event Type Comment
16 Oct 2023 Other trial event Last checked against Clinicaltrials.gov record. Updated 16 Oct 2023
12 Oct 2023 Other trial event Planned primary completion date changed from 18 Mar 2023 to 10 Mar 2024. Updated 16 Oct 2023
12 Oct 2023 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 16 Oct 2023
26 Apr 2022 Protocol amendment Treatments section has been updated to replace Losartan with Angiotensin II receptor blockers. The type of ARB received will be dependent on what is available at the hospitals. Updated 06 May 2022
01 Apr 2022 Protocol amendment Phase of the trial has been changed from 2 to 3, treatments section is updated to increase number of arms from 3 to 7 by the removal of Interferon and Remdesivir and the addition of new experimental arms for the drugs Artesunate, Imatinib, Infliximab, Losartan and Dexamethasone along with Control (Standard Care) arm. Updated 10 Apr 2022
01 Apr 2022 Completion date Planned End Date changed from 18 May 2022 to 18 May 2024. Updated 10 Apr 2022
01 Apr 2022 Other trial event Planned primary completion date changed from 18 Mar 2022 to 18 Mar 2023. Updated 10 Apr 2022
14 Feb 2022 Other trial event According to an Arch Biopartners media release, this study is being conducted in up to fifty-five hospitals across Canada to find new treatments for patients suffering from the complications caused by COVID-19. CATCO is supported by the Canadian Network of COVID-19 Clinical Trials Networks which is funded by the Canadian Institutes of Health Research. Updated 16 Feb 2022
14 Feb 2022 Other trial event According to an Arch Biopartners media release, the Health Canada has approved the amendment to the CATCO protocol to include, LSALT Peptide (LSALT and Metablok) in a new dosing arm of the trial. The Health Canada has issued a No Objection Letter for the Clinical Trial Application. Dosing of LSALT peptide is expected to begin following final local approval and clinical site preparation. Updated 16 Feb 2022
19 Jan 2022 Results Results published in the CMAJ: Canadian Medical Association Journal Updated 31 Jan 2022
04 Jan 2022 Other trial event According to an Arch Biopartners media release, the company's primary responsibility is to supply of LSALT drug vials to support the dosing of up to approximately 350 patients. Updated 07 Jan 2022
04 Jan 2022 Protocol amendment According to an Arch Biopartners media release, the Research Ethics Board at the Sunnybrook Research Institue has approved the amendment to the CATCO protocol to include LSALT Peptide in a new arm of the trial and the company will seek Health Canada approval before commencing the dosing of LSALT in the new arm. Updated 07 Jan 2022
01 Dec 2021 Other trial event According to an Arch Biopartners media release, Dr. Rob Fowler Principal Investigator of this study. Updated 09 Dec 2021
01 Dec 2021 Other trial event According to an Arch Biopartners media release, Sunnybrook Research Institute (SRI) has entered into a collaboration agreement with Arch Biopartners to use LSALT in a new arm of the this study and SRI and CATCO leadership will now seek ethics committee and Health Canada approvals before commencing the dosing of LSALT in the trial. Updated 09 Dec 2021
01 Dec 2021 Protocol amendment According to an Arch Biopartners media release, LSALT Peptide entered into this study Updated 09 Dec 2021
01 Jul 2021 Results Results(n=12) assessing case series of severe hyponatremia and 32 fold overdose raising safety and effectiveness concerns in covid-19 pateints published in the Clinical Toxicology Updated 04 Aug 2021
09 Nov 2020 Protocol amendment Protocol of the study has been amended number of arms has been changed to 3 from 4,Interferon beta-1a has been added and hydroxychloroquine been removed, lopinavir/ritonavir also removed from treatment arm Updated 04 Aug 2021
04 Jul 2020 Other trial event Based on interim analysis, the World Health Organization reported the Solidarity Trials recommendation to immediately discontinue the LPV/r treatment arms due to futility and safety concerns. Updated 09 Dec 2021
04 Jun 2020 Other trial event Planned number of patients changed from 440 to 2900. Updated 08 Jun 2020
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov

  2. Arch Biopartners. Research Ethics Board approves amendment to Canadian Treatments for COVID-19 (CATCO) Trial to include LSALT Peptide (Metablok). Media-Rel 2022;.

    Media Release

  3. Arch Biopartners. Canadian Treatments for COVID-19 (CATCO) Trial Receives Approval from Health Canada to Amend Protocol to include LSALT Peptide (Metablok). Media-Rel 2022;.

    Media Release

  4. Ali K, Azher T, Baqi M, Binnie A, Borgia S, Carrier FM, et al. Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial. . CMAJ 2022;.

    PubMed | CrossRef Fulltext

  5. Arch Biopartners. Arch Biopartners Lead Drug LSALT Peptide to Enter the Canadian Treatments for COVID-19 (CATCO) Trial. Media-Rel 2021;.

    Media Release

  6. Lepage MA, Rozza N, Kremer R, Grunbaum A. Safety and effectiveness concerns of lopinavir/ritonavir in COVID-19 affected patients: a retrospective series. Clin-Toxicol-(Phila) 2021;59(7):644-647.

    PubMed | CrossRef Fulltext
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