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

Primary Purpose

Coronavirus Infection, Sepsis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
recombinant human annexin A5
Placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low dose

High dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Enrollment
Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients
Protocol adherence
Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90%
Data completeness
Case Report Forms completed with <10% missing data after verification and monitoring

Secondary Outcome Measures

Organ failure
Sequential Organ Failure Assessment (SOFA) at 30 days; range 0 (normal) to 24
Organ function at end of treatment measured with SOFA
SOFA at end of treatment (EOT)
Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)
MODS at end of treatment (EOT); range 0 (normal) to 24
Individual organ function scores at EOT measured with SOFA
SOFA for individual organ systems
Individual organ function scores at 30 days measured with SOFA
SOFA for individual organ systems
Individual organ function scores at EOT measured with MODS
MODS for individual organ systems
Individual organ function scores at 30 days measured with MODS
MODS for individual organ systems
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
Mortality at 60 days
All cause mortality
Hospital mortality
Hospital mortality censored at 60 days
Ventilator-free days
Days alive and off ventilator at 30 days
ICU-free days
Days alive and not in ICU at 30 days
Number of participants with persistent organ dysfunction
MODS score greater or equal to 2 in any organ system at day 30
Number of serious adverse events (SAE)
SAE
Maximum plasma concentration (Cmax) of annexin A5 (SY-005)
Pharmacokinetic profile on day 1
Elimination half-life of annexin A5 (SY-005)
Pharmacokinetic profile on day 1
Number of participants with anti-annexin A5 antibodies
Anti-annexin A5 antibodies

Full Information

First Posted
February 2, 2021
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Ministry of Colleges and Universities, London Health Sciences Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04748757
Brief Title
Annexin A5 in Patients With Severe COVID-19 Disease
Acronym
AX-COVID
Official Title
Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
April 3, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Ministry of Colleges and Universities, London Health Sciences Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 19 years Positive test for SARS-CoV-2 virus (anytime during current illness episode) Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation) Exclusion Criteria: Known allergy to any of the ingredients or components of the investigational product Known pregnancy Moribund and not expected to survive beyond 24 hours 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) Acute or chronic renal failure (dialysis dependent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Martin, MD, MSc
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information and data sharing will be considered on individual basis at conclusion of the study.
IPD Sharing Time Frame
To be evaluated on individual basis

Learn more about this trial

Annexin A5 in Patients With Severe COVID-19 Disease

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