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Completed

NCT Number: NCT04748757

Annexin A5 in Patients With Severe COVID-19 Disease

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

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Inflammation Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Sepsis Systemic Inflammatory Response Syndrome Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

recombinant human annexin A5

Drug

recombinant human annexin A5, manufactured as SY-005

Other names: SY-005

Placebo

Drug

Normal saline 50 ml

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • London Health Sciences Foundation
  • Ontario Ministry of Colleges and Universities

Registry information

Official study title

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

Acronym: AX-COVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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