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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 : June 5, 2020
Sponsor:
Collaborators:
AbbVie
Apotex 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.

Subjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.

Participants will be randomized to one of the following groups:

  1. Lopinavir/ritonavir 400mg/100mg PO BID for 14 day plus optimized supportive care, OR
  2. Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care, OR
  3. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR
  4. Optimized support care all or until discharge from hospital, whichever occurs first

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: remdesivir Phase 2

Detailed Description:

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 standard of care, while being hospitalized for COVID-19.

Participants will be randomized to one of the following groups:

  1. Lopinavir/ritonavir 400mg/100mg PO BID for 14 day plus optimized supportive care, OR
  2. Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care, OR
  3. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR
  4. Optimized support care all or until discharge from hospital, whichever occurs first

Subjects will be assessed daily while hospitalized, including Oropharyngeal (OP) / Nasopharyngeal (NP) swabbing at baseline and on days post enrolment 3, 5, 8, 11, 15 and 29 (if still hospitalized, exploratory outcome). Discharged subjects will be telephoned at Days 11, 15 29, and 60. Hospitalized subjects will require blood sampling on days 1, 5 and 11.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

4-arms in a 1:1:1:1 ratio randomization to either the control arm, consisting of standard supportive care treatment for COVID-19, or the investigational product, lopinavir/ritonavir plus standard supportive care; hydroxychloroquine plus standard supportive care; and remdesivir plus standard supportive care

This study is intended to allow for multiple adaptations, including: i) the primary endpoint at the first interim analysis, based on performance characteristics, both in its characteristics and its timepoint, with adapted sample size calculations performed for the new primary endpoints; ii) Intervention arm, with emerging data from both internal and external to the trial, with arms being dropped or added based on pre-specified stopping rules in conjunction with the DSMB.

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, 2022
Estimated Study Completion Date : May 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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

Experimental: 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

Experimental: 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




Primary Outcome Measures :
  1. Efficacy of Interventions as assessed by all-cause mortality [ Time Frame: 29 days ]
    All-cause mortality, assessed at hospital discharge.


Secondary Outcome Measures :
  1. Time to improvement of one category from admission [ Time Frame: up to 60 days ]
    Measure with Ordinal Scale the time it takes for subject improvement

  2. Subject clinical status [ Time Frame: up to 60 days ]

    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

    1. Asymptomatic, viral RNA detected
    2. Symptomatic, independent
    3. Symptomatic, Assistance Needed
    4. Hospitalized: no oxygen therapy
    5. Hospitalized, on oxygen
    6. Hospitalized, Oxygen by NIV or high-flow
    7. Mechanical ventilation, p/f>150 or s/f >200
    8. Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors
    9. mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO
    10. death

  3. Change in Subject clinical status [ Time Frame: up to 60 days ]

    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

    1. Asymptomatic, viral RNA detected
    2. Symptomatic, independent
    3. Symptomatic, Assistance Needed
    4. Hospitalized: no oxygen therapy
    5. Hospitalized, on oxygen
    6. Hospitalized, Oxygen by NIV or high-flow
    7. Mechanical ventilation, p/f>150 or s/f >200
    8. Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors
    9. mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO
    10. death

  4. Oxygen free days [ Time Frame: up to 29 days ]
    the number of oxygen free days experienced

  5. Incidence of oxygen use [ Time Frame: up to 29 days ]
    if the subject required oxygen during hospitalization

  6. Duration of oxygen use [ Time Frame: up to 29 days ]
    if the subject required oxygen, for how long was it required

  7. Incidence of new mechanical ventilation [ Time Frame: up to 29 days ]
    if the subject required mechanical ventilation during hospitalization

  8. Duration of mechanical ventilation [ Time Frame: up to 29 days ]
    if the subject required mechanical ventilation, for how long was it required

  9. Duration of hospitalization [ Time Frame: up to 29 days ]
    the length of hospitalization required

  10. Mortality [ Time Frame: up to 60 days ]
    Mortality rates calculated at day 15, 29, and 60.

  11. Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 30 days after last dose of drug adminstration ]
    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).


Other Outcome Measures:
  1. Time to viral clearance of lopinavir/ritonavir as compared to the control arm [ Time Frame: up to 29 days ]
    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



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:

  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

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

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: Srinivas Murthy, MD (604) 875-2778 srinivas.murthy@cw.bc.ca
Contact: Gail Klein 416-480-5632 CATCO@sunnybrook.ca

Locations
Show Show 25 study locations
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
AbbVie
Apotex Inc.
Investigators
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Study Director: Vaseeharan Sathiyamoorthy World Health Organization
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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: June 5, 2020
Last Verified: June 2020
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:
Lopinavir/ritonavir
Hydroxychloroquine
Remdesivir
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Hydroxychloroquine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents