Inhaled Heparin for Hospitalised COVID-19 Patients

  • STATUS
    Recruiting
  • End date
    Jun 1, 2021
  • participants needed
    712
  • sponsor
    Australian National University
Updated on 28 January 2021

Summary

This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will be conducted in multiple countries, including Australia, the UK, Argentina, Brazil and Egypt.

Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, will be randomised to inhaled nebulised heparin or standard care for up to 21 days or until the patient has no respiratory symptoms. All studies will collect a minimum core dataset. The primary outcome for the meta-trial is the proportion of patients who receive invasive mechanical ventilation censored at day 28. Individual studies may have specific outcome measures in addition to the core set.

Details
Condition COVID19
Treatment Unfractionated heparin
Clinical Study IdentifierNCT04635241
SponsorAustralian National University
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have COVID19??
Patients admitted to hospital with COVID-19
No immediate requirement for mechanical ventilation (points 3-5 on the WHO ordinal scale)
Age equal to or greater than 18
Able to provide informed consent

Exclusion Criteria

Pregnant women
Known allergy to Heparin
Participant in another clinical trial that is not approved for joint enrollment
APTT> 120 seconds, not due to anticoagulant therapy
Platelet count <20 x 109 per L
Lung bleeding
Uncontrolled bleeding
Advanced neurological impairment
Advanced oncological disease
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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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