Annexin A5 in Patients With Severe COVID-19 Disease

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    60
  • sponsor
    Lawson Health Research Institute
Updated on 7 May 2021

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

Details
Condition Coronavirus Infection, Septicemia, Sepsis and Septicemia, Coronavirus, Sepsis and Septicemia, systemic infection, systemic infections, sepsis, sepsis syndrome
Treatment Placebo, recombinant human annexin A5
Clinical Study IdentifierNCT04748757
SponsorLawson Health Research Institute
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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