Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)
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| ClinicalTrials.gov Identifier: NCT04330690 |
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Recruitment Status :
Recruiting
First Posted : April 1, 2020
Last Update Posted : January 13, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Artesunate Drug: Imatinib Drug: Infliximab Drug: Dexamethasone Drug: LSALT Peptide | Phase 3 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Artesunate
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
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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 |
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Experimental: Imatinib
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
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Drug: Imatinib
400 mg enterally daily for 14 days plus standard of care |
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Experimental: Infliximab
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
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Drug: Infliximab
5 mg/kg IV given one time, over 2 hours plus standard of care |
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Experimental: Dexamethasone
Subjects will be randomized between Dexamethasone vs standard of care.
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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 |
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Experimental: LSALT Peptide
Subjects will be randomized between LSALT vs standard of care.
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Drug: LSALT Peptide
5 mg , 2 hour IV infusion once daily for up to 14 consecutive days |
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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.
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- Randomization WHO- Mortality [ Time Frame: 28 days ]All-cause mortality, assessed at hospital discharge.
- 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
- Randomization LSALT- Respiratory support [ Time Frame: 28 days ]Number of days respiratory support free days
- Evaluation of the clinical effectiveness of study drugs [ Time Frame: 24 months ]To be compared to the control arm on duration of hospitalization
- 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 ]
- Mortality [ Time Frame: 12 months ]Mortality after Randomization
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
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
Exclusion Criteria:
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:
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
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
| Contact: Rob Fowler, MD | 416-480-6100 | rob.fowler@sunnybrook.ca | |
| Contact: Gail Klein | 416-480-5632 | CATCO@sunnybrook.ca |
Show 57 study locations
| Principal Investigator: | Srinivas Murthy, MD | Provincial Health Services Authority |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 13, 2023 |
| Last Verified: | January 2023 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Artesunate Infliximab Imatinib |
Dexamethasone SARS-CoV-2 LSALT Peptide |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Artesunate Dexamethasone Infliximab |
Imatinib Mesylate 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 |