Official Title
INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial
Brief 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, 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.

Active, not recruiting
COVID19

Drug: Unfractionated heparin

Inhaled nebulised 6 hourly

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Egypt
Indonesia
Locations

San Camilo Clinic
Buenos Aires, Argentina

15th May hospital
Cairo, Egypt

RS Universitas Indonesia
Depok, Indonesia

RSUP Dr Cipto Mangunkusumo
Jakarta, Indonesia

RSUD Dr Moewardi
Surakarta, Indonesia

Frank MP van Haren, MD, PhD, Study Chair
Australian National University

Australian National University
NCT Number
MeSH Terms
COVID-19
Heparin
Calcium heparin