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

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ClinicalTrials.gov Identifier: NCT04748757
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Ontario Ministry of Colleges and Universities
London Health Sciences Foundation
Information provided by (Responsible Party):
Lawson Health Research Institute

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

Condition or disease Intervention/treatment Phase
Coronavirus Infection Sepsis Drug: recombinant human annexin A5 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days
Drug: Placebo
Normal saline 50 ml

Experimental: Low dose
50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
Drug: recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
Other Name: SY-005

Experimental: High dose
100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
Drug: recombinant human annexin A5
recombinant human annexin A5, manufactured as SY-005
Other Name: SY-005




Primary Outcome Measures :
  1. Enrollment [ Time Frame: 12 months ]
    Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients

  2. Protocol adherence [ Time Frame: 7 days ]
    Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90%

  3. Data completeness [ Time Frame: 12 months ]
    Case Report Forms completed with <10% missing data after verification and monitoring


Secondary Outcome Measures :
  1. Organ failure [ Time Frame: 30 days ]
    Sequential Organ Failure Assessment (SOFA) at 30 days; range 0 (normal) to 24

  2. Organ function at end of treatment measured with SOFA [ Time Frame: 7 days ]
    SOFA at end of treatment (EOT)

  3. Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS) [ Time Frame: 7 days ]
    MODS at end of treatment (EOT); range 0 (normal) to 24

  4. Individual organ function scores at EOT measured with SOFA [ Time Frame: 30 days ]
    SOFA for individual organ systems

  5. Individual organ function scores at 30 days measured with SOFA [ Time Frame: 30 days ]
    SOFA for individual organ systems

  6. Individual organ function scores at EOT measured with MODS [ Time Frame: 30 days ]
    MODS for individual organ systems

  7. Individual organ function scores at 30 days measured with MODS [ Time Frame: 30 days ]
    MODS for individual organ systems

  8. Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14 [ Time Frame: 14 days ]
    Annexin A5 will be measured daily during treatment and on day 14

  9. Mortality at 60 days [ Time Frame: 60 days ]
    All cause mortality

  10. Hospital mortality [ Time Frame: 60 days ]
    Hospital mortality censored at 60 days

  11. Ventilator-free days [ Time Frame: 30 days ]
    Days alive and off ventilator at 30 days

  12. ICU-free days [ Time Frame: 30 days ]
    Days alive and not in ICU at 30 days

  13. Number of participants with persistent organ dysfunction [ Time Frame: 30 days ]
    MODS score greater or equal to 2 in any organ system at day 30

  14. Number of serious adverse events (SAE) [ Time Frame: 60 days ]
    SAE

  15. Maximum plasma concentration (Cmax) of annexin A5 (SY-005) [ Time Frame: 1 day ]
    Pharmacokinetic profile on day 1

  16. Elimination half-life of annexin A5 (SY-005) [ Time Frame: 1 day ]
    Pharmacokinetic profile on day 1

  17. Number of participants with anti-annexin A5 antibodies [ Time Frame: 21 days ]
    Anti-annexin A5 antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748757


Contacts
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Contact: Eileen Campbell 5196858090 eileen.campbell@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Eileen Campbell    519-685-8500 ext 55664    eileen.campbell@lhsc.on.ca   
Contact: Claudio Martin, MD, MSc    519-685-8500 ext 58090    cmartin1@uwo.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Ministry of Colleges and Universities
London Health Sciences Foundation
Investigators
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Principal Investigator: Claudio Martin, MD, MSc Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04748757    
Other Study ID Numbers: REDA-10122
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information and data sharing will be considered on individual basis at conclusion of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: To be evaluated on individual basis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Annexin A5
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action