Annexin A5 in Patients With Severe COVID-19 Disease

Sepsis Clinical Trial

— AX-COVID  

Official title:

Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748757
• Other study ID #: REDA-10122
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2022
• Est. primary completion date: April 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Sepsis

Intervention

Drug:
• recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
• Placebo
Normal saline 50 ml

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	London Health Sciences Foundation, Ontario Ministry of Colleges and Universities

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients	12 months
Primary	Protocol adherence	Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90%	7 days
Primary	Data completeness	Case Report Forms completed with <10% missing data after verification and monitoring	12 months
Secondary	Organ failure	Sequential Organ Failure Assessment (SOFA) at 30 days; range 0 (normal) to 24	30 days
Secondary	Organ function at end of treatment measured with SOFA	SOFA at end of treatment (EOT)	7 days
Secondary	Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)	MODS at end of treatment (EOT); range 0 (normal) to 24	7 days
Secondary	Individual organ function scores at EOT measured with SOFA	SOFA for individual organ systems	30 days
Secondary	Individual organ function scores at 30 days measured with SOFA	SOFA for individual organ systems	30 days
Secondary	Individual organ function scores at EOT measured with MODS	MODS for individual organ systems	30 days
Secondary	Individual organ function scores at 30 days measured with MODS	MODS for individual organ systems	30 days
Secondary	Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14	Annexin A5 will be measured daily during treatment and on day 14	14 days
Secondary	Mortality at 60 days	All cause mortality	60 days
Secondary	Hospital mortality	Hospital mortality censored at 60 days	60 days
Secondary	Ventilator-free days	Days alive and off ventilator at 30 days	30 days
Secondary	ICU-free days	Days alive and not in ICU at 30 days	30 days
Secondary	Number of participants with persistent organ dysfunction	MODS score greater or equal to 2 in any organ system at day 30	30 days
Secondary	Number of serious adverse events (SAE)	SAE	60 days
Secondary	Maximum plasma concentration (Cmax) of annexin A5 (SY-005)	Pharmacokinetic profile on day 1	1 day
Secondary	Elimination half-life of annexin A5 (SY-005)	Pharmacokinetic profile on day 1	1 day
Secondary	Number of participants with anti-annexin A5 antibodies	Anti-annexin A5 antibodies	21 days