Annexin A5 in Patients With Severe COVID-19 Disease

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 with 2 intensive care units

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: London Health Sciences Foundation; Ontario Ministry of Colleges and Universities
• Treatments: Annexin A5

Criteria

Inclusion Criteria:

1. Age ≥ 19 years

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:

1. Known allergy to any of the ingredients or components of the investigational product

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)