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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)

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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Jun 2020

At a glance

  • Drugs Lopinavir/ritonavir (Primary) ; Hydroxychloroquine; Remdesivir
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms CATCO
  • Most Recent Events

    • 06 Apr 2020 New trial record

Trial Overview

Purpose

This study is an adaptive, randomized, open-label, controlled clinical trial to assess the efficacy of Lopinavir/ritonavir in subjects hospitalized with COVID-19 infection.

Primary Endpoints

Efficacy of Intervention

description: The overall objective of the study is to evaluate the clinical efficacy and safety of lopinavir/ritonavir relative to the control arm in participants hospitalized with COVID-19, specifically looking at the subjects clinical status at day 29 as measured on a 10-point ordinal scale through a proportional odds model.
The scale is as below 0: Uninfected, no viral RNA
Asymptomatic, viral RNA detected
Symptomatic, independent
Symptomatic, Assistance Needed
Hospitalized: no oxygen therapy
Hospitalized, on oxygen
Hospitalized, Oxygen by NIV or high-flow
Mechanical ventilation, p/f>150 or s/f >200
Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors
mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO
death
time_frame: 29 days

Other Endpoints

Time to improvement of one category from admission

description: Measure with Ordinal Scale the time it takes for subject improvement
time_frame: up to 60 days

Subject clinical status

description: Subject clinical status at days 3, 5, 8, 11, 15, 29, 60 measured using the ordinal scale below:
The scale is as below 0: Uninfected, no viral RNA
Asymptomatic, viral RNA detected
Symptomatic, independent
Symptomatic, Assistance Needed
Hospitalized: no oxygen therapy
Hospitalized, on oxygen
Hospitalized, Oxygen by NIV or high-flow
Mechanical ventilation, p/f>150 or s/f >200
Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors
mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO
death
time_frame: up to 60 days

Change in Subject clinical status

description: Mean change in the ranking from baseline to days 3, 5, 8, 11, 15, 29, 60 using the ordinal scale below:
The scale is as below 0: Uninfected, no viral RNA
Asymptomatic, viral RNA detected
Symptomatic, independent
Symptomatic, Assistance Needed
Hospitalized: no oxygen therapy
Hospitalized, on oxygen
Hospitalized, Oxygen by NIV or high-flow
Mechanical ventilation, p/f>150 or s/f >200
Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors
mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO
death
time_frame: up to 60 days

Oxygen free days

description: the number of oxygen free days experienced
time_frame: up to 29 days

Incidence of oxygen use

description: if the subject required oxygen during hospitalization
time_frame: up to 29 days

Duration of oxygen use

description: if the subject required oxygen, for how long was it required
time_frame: up to 29 days

Incidence of new mechanical ventilation

description: if the subject required mechanical ventilation during hospitalization
time_frame: up to 29 days

Duration of mechanical ventilation

description: if the subject required mechanical ventilation, for how long was it required
time_frame: up to 29 days

Duration of hospitalization

description: the length of hospitalization required
time_frame: up to 29 days

Mortality

description: Mortality rates calculated at day 15, 29, and 60.
time_frame: up to 60 days

Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)

description: The safety of the intervention will be evaluated during the trial period as compared to the control arm as assessed by the cumulative incidence of Grade 3 and 4 AEs and SAEs using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, version 2.1 (July 2017).
time_frame: up to 30 days after last dose of drug adminstration

Time to viral clearance of lopinavir/ritonavir as compared to the control arm

description: To evaluate the virologic efficacy of lopinavir/ritonavir, hydroxychloroquine, or remdesivir as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP sample at days 3, 5, 8, 11, 15, and 29
time_frame: up to 29 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 440

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

Patient Inclusion Criteria

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 prior to randomization. 3. Hospitalized at a participating centre

Patient Exclusion Criteria

1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Expected to not survive beyond 24 hours 3. Known allergy to study medication or its components (non-medicinal ingredients) 4. Receiving one of the study drugs at time of enrolment 5. Known pregnancy

Trial Details

Identifiers

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

Organisations

  • Affiliations AbbVie

Trial Dates

  • Initiation Dates

    Actual : 18 Mar 2020

  • Primary Completion Dates

    Planned : 18 Mar 2022

  • End Dates

    Planned : 18 May 2022

Other Details

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

Interventions

Drugs Route Formulation
Hydroxychloroquine
-
-
Lopinavir/ritonavirPrimary Drug Oral Suspension, Tablet
Remdesivir Intravenous Infusion

lopinavir/ritonavir plus standard supportive care

Lopinavir/ritonavir will be administered 400 mg/100 mg orally for a 14-day course, or until discharge from hospital, whichever occurs first plus expected standard supportive care. Drug: Lopinavir/ritonavir (Lopinavir/ritonavir will be administered 400 mg/100 mg orally for a 14-day course plus supportive care, or until discharge from hospital, whichever occurs first)

hydroxychloroquine plus standard supportive care

Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care Drug: Hydroxychloroquine (Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care or until discharge from hospital, whichever occurs first)

Remdesivir plus standard supportive care

Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care Drug: remdesivir (Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care or until discharge from hospital, whichever occurs first)

Control

This arm will receive standard supportive care guidelines for COVID-19. This is expected the vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Trial Centres

Investigators

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, MD Toronto Western Hospital 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
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 - 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
Gail Klein
416-480-5632 CATCO@sunnybrook.ca
show details
-
Irene Watpool
613-737-8899 78724 iwatpool@ohri.ca
show details
The Ottawa Hospital - General Campus Canada
Kimberly Robertson
780-407-6945 Kimberly.Robertson2@albertahealthservices.ca
show details
University of Alberta Hopsital 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
Lisette Machado
lmachado@ucalgary.ca
show details
Rockyview General Hospital 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
Matthew Cheng, MD McGill University Health Centre-Glen Site Royal Victoria 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
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
Rhyan Pineda
514-290-7369 rhyan.pineda@muhc.mcgill.ca
show details
McGill University Health Centre-Glen Site Royal Victoria Hospital Canada
Seema Parvathy
519-646-6100 61726 SeemaNair.Parvathy@sjhc.london.on.ca
show details
St.Joseph's Health Care Canada
Shane English, MD The Ottawa Hospital - Civic Campus, The Ottawa Hospital - General Campus 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
Vaseeharan Sathiyamoorthy World Health Organization
-

Centres

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
Foothills Medical Centre Calgary, Alberta Canada
Hôpital Montfort Ottawa, Ontario Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval Québec, Quebec Canada
Island Health - Royal Jubilee Hospital Victoria, British Columbia Canada
Island Health - Victoria General Hospital Victoria, British Columbia Canada
McGill University Health Centre-Glen Site Royal Victoria Hospital Montréal, Quebec Canada
North York General Hospital Toronto, Ontario Canada
Peter Lougheed Centre Calgary, Alberta Canada
Rockyview General Hospital Calgary, Alberta Canada
South Health Campus Calgary, Alberta Canada
St Paul's Hospital Vancouver, British Columbia Canada
St. Joseph's Healthcare Hamilton Hamilton, 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
Toronto Western Hospital 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
World Health Organization
-
-

Trial History

Event Date Event Type Comment
03 Jun 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 03 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 2016;.

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