Inhaled Heparin for Hospitalised COVID-19 Patients

Conditions

Covid19

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.

van Haren FMP, Valle SJ, Neto AS, Schultz MJ, Laffey JG, Artigas A, Dixon B, Vilaseca AB, Barbera RA, Ismail TI, Mahrous RS, Badr M, DeNucci G, Sverdloff C, Camprubi-Rimblas M, Cosgrave DW, McNicholas B, Cody C, Curley G, Smoot TL, Staas S, Sann K, Sas C, Belani A, Hillman C, Manggala SK, Aditianingsih D, Sugiarto A, Yulianti M, Herikurniawan H, Sinto R, Auerkari AN, Permana SA, Woodcock A, Carroll M, Wilkinson T, Singh D, Shute JK, Carroll M, Page C.

2025-09-27

10.1016/j.eclinm.2025.103339

INHALEd nebulised unfractionated HEParin for the treatment of hospitalised patients with COVID‐19 (INHALE‐HEP): Protocol and statistical analysis plan for an investigator‐initiated international metatrial of randomised studies

Frank van Haren, Alice Richardson, Hwan‐Jin Yoon, Antonio Artigas, John G. Laffey et al. (29 authors)

British Journal of Clinical Pharmacology2020-12-3030 citations

10.1111/bcp.14714

Interventions

DRUGUnfractionated heparin

Inhaled nebulised 6 hourly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Intubation rate	Day 28	Proportion of patients requiring invasive mechanical ventilation

Secondary

Measure	Time frame	Description
WHO ordinal scale COVID19	Day 7	Number of patients showing 1 or 2 point worsening on the ordinal scale
Oxygenation	Day 7	Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2)

Countries

Argentina, Egypt, Indonesia

Outcome results

None listed