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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330690
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : August 18, 2022
Sponsor:
Collaborators:
AbbVie
Apotex Inc.
World Health Organization
University of British Columbia
Arch Biopartners Inc.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Artesunate Drug: Imatinib Drug: Infliximab Drug: Dexamethasone Drug: LSALT Peptide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Endpoint assessment
Primary Purpose: Treatment
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)
Actual Study Start Date : March 18, 2020
Estimated Primary Completion Date : March 18, 2023
Estimated Study Completion Date : May 18, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Experimental: 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

Experimental: 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

Experimental: 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

Experimental: 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

No Intervention: 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.



Primary Outcome Measures :
  1. Randomization WHO- Mortality [ Time Frame: 28 days ]
    All-cause mortality, assessed at hospital discharge.

  2. Randomization Dex- Clinical Status [ Time Frame: 28 days ]

    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


  3. Randomization LSALT- Respiratory support [ Time Frame: 28 days ]
    Number of days respiratory support free days


Secondary Outcome Measures :
  1. Evaluation of the clinical effectiveness of study drugs [ Time Frame: 24 months ]
    To be compared to the control arm on duration of hospitalization

  2. Need for invasive mechanical ventilation [ Time Frame: 24 months ]
  3. CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT [ Time Frame: 24 months ]
  4. Mortality [ Time Frame: 12 months ]
    Mortality after Randomization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330690


Contacts
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Contact: Rob Fowler, MD 416-480-6100 rob.fowler@sunnybrook.ca
Contact: Gail Klein 416-480-5632 CATCO@sunnybrook.ca

Locations
Show Show 57 study locations
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
AbbVie
Apotex Inc.
World Health Organization
University of British Columbia
Arch Biopartners Inc.
Investigators
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Principal Investigator: Srinivas Murthy, MD Provincial Health Services Authority
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04330690    
Other Study ID Numbers: 2114
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Unknown and variable

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Artesunate
Infliximab
Imatinib
Dexamethasone
SARS-CoV-2
LSALT Peptide
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Artesunate
Dexamethasone
Imatinib Mesylate
Infliximab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action