Inhaled Heparin for Hospitalised COVID-19 Patients (INHALE-HEP)

Australian National University (ANU)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Covid19

Treatments

Drug: Unfractionated heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT04635241

INHALE-HEP meta-trial

Details and patient eligibility

About

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, the USA, Ireland, 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.

Enrollment

485 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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