A Phase 3 interventional study of Artesunate and Imatinib in COVID-19, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 53 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Sunnybrook Health Sciences Centre · Phase 3, Interventional, and Treatment
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, 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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 2,900 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Each participant must meet all of the following inclusion criteria to participate in this study:
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
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
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:
Imatinib:
Infliximab:
Randomization LSALT:
Randomization Dex:
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Drug: Artesunate
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Drug: Imatinib
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
Drug: Infliximab
Subjects will be randomized between Dexamethasone vs standard of care.
Drug: Dexamethasone
Subjects will be randomized between LSALT vs standard of care.
Drug: LSALT Peptide
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.
2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care
400 mg enterally daily for 14 days plus standard of care
5 mg/kg IV given one time, over 2 hours plus standard of care
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
5 mg , 2 hour IV infusion once daily for up to 14 consecutive days
Randomization WHO- Mortality
All-cause mortality, assessed at hospital discharge.
Time frame: 28 days
Randomization Dex- Clinical Status
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
Randomization LSALT- Respiratory support
Number of days respiratory support free days
Time frame: 28 days
Evaluation of the clinical effectiveness of study drugs
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
Mortality
Mortality after Randomization
Time frame: 12 months
Plan to share: Yes — 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 information: Study protocol, Sap, Csr
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre