Clinical trial NCT04748757: Annexin A5 in Patients With Severe COVID-19 Disease
Official title: Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus Infection
Sepsis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Colleges and Universities
name: London Health Sciences Foundation
First posted: 2021-02-10
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with 2 intensive care units


Eligibility 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)

Primary outcomes:
measure: Enrollment
timeFrame: 12 months
measure: Protocol adherence
timeFrame: 7 days
measure: Data completeness
timeFrame: 12 months
Secondary outcomes:
measure: Organ failure
timeFrame: 30 days
measure: Organ function at end of treatment measured with SOFA
timeFrame: 7 days
measure: Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)
timeFrame: 7 days
measure: Individual organ function scores at EOT measured with SOFA
timeFrame: 30 days
measure: Individual organ function scores at 30 days measured with SOFA
timeFrame: 30 days
measure: Individual organ function scores at EOT measured with MODS
timeFrame: 30 days
measure: Individual organ function scores at 30 days measured with MODS
timeFrame: 30 days
measure: Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14
timeFrame: 14 days
measure: Mortality at 60 days
timeFrame: 60 days
measure: Hospital mortality
timeFrame: 60 days
measure: Ventilator-free days
timeFrame: 30 days
measure: ICU-free days
timeFrame: 30 days
measure: Number of participants with persistent organ dysfunction
timeFrame: 30 days
measure: Number of serious adverse events (SAE)
timeFrame: 60 days
measure: Maximum plasma concentration (Cmax) of annexin A5 (SY-005)
timeFrame: 1 day
measure: Elimination half-life of annexin A5 (SY-005)
timeFrame: 1 day
measure: Number of participants with anti-annexin A5 antibodies
timeFrame: 21 days
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Claudio Martin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: