Annexin A5 in Patients With Severe COVID-19 Disease (AX-COVID)

Lawson Health Research Institute

Status and phase: Completed; Phase 2

Conditions: Sepsis; Coronavirus Infection

Treatments: Drug: recombinant human annexin A5; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04748757

REDA-10122

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days

Treatment:

Drug: Placebo

Low dose

Experimental group

Description:

50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days

Treatment:

Drug: recombinant human annexin A5

High dose

Experimental group

Description:

100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days

Treatment:

Drug: recombinant human annexin A5