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
Drug: recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
Other Name: SY-005
Drug: Placebo
Normal saline 50 ml
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)
London Health Sciences Centre
London, Ontario, Canada
Claudio Martin, MD, MSc, Principal Investigator
Lawson Health Research Institute