Status:
COMPLETED
Annexin A5 in Patients With Severe COVID-19 Disease
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Ontario Ministry of Colleges and Universities
London Health Sciences Foundation
Conditions:
Coronavirus Infection
Sepsis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre wi...
Eligibility Criteria
Inclusion
- Age ≥ 19 years
- Positive test for SARS-CoV-2 virus (anytime during current illness episode)
- Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)
Exclusion
- Known allergy to any of the ingredients or components of the investigational product
- Known pregnancy
- Moribund and not expected to survive beyond 24 hours
- Known or suspected risk for serious bleeding complications (note that Disseminated Intravascular Coagulopathy (DIC) is an expected finding in patient with sepsis and COVID-19 disease and is not an exclusion criterion on its own)
- Acute or chronic renal failure (dialysis dependent)
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04748757
Start Date
April 20 2021
End Date
December 1 2022
Last Update
March 8 2023
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9