NCT04330690

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,900 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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
DRUG	Imatinib	400 mg enterally daily for 14 days plus standard of care
DRUG	Infliximab	5 mg/kg IV given one time, over 2 hours plus 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
DRUG	LSALT Peptide	5 mg , 2 hour IV infusion once daily for up to 14 consecutive days

Timeline

• Start date: 2020-03-18
• Primary completion: 2024-03-10
• Completion: 2024-05-18
• First posted: 2020-04-01
• Last updated: 2023-10-13

Locations

53 sites across 1 country: Canada