Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2021-04-20
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days
Placebo
Normal saline 50 ml
Low dose
50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
High dose
100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
Interventions
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recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
Placebo
Normal saline 50 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Positive test for SARS-CoV-2 virus (anytime during current illness episode)
3. Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)
Exclusion Criteria
2. Known pregnancy
3. Moribund and not expected to survive beyond 24 hours
4. 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)
5. Acute or chronic renal failure (dialysis dependent)
19 Years
ALL
No
Sponsors
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Ontario Ministry of Colleges and Universities
UNKNOWN
London Health Sciences Foundation
UNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Claudio Martin, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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London Health Sciences Centre
London, Ontario, Canada
Countries
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References
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Tschirhart BJ, Lu X, Mokale Kognou AL, Martin CM, Slessarev M, Fraser DD, Leligdowicz A, Urquhart B, Feng Q. Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. Front Pharmacol. 2024 Jan 10;14:1299613. doi: 10.3389/fphar.2023.1299613. eCollection 2023.
Other Identifiers
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REDA-10122
Identifier Type: -
Identifier Source: org_study_id
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