Inhaled Heparin for Hospitalised COVID-19 Patients

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.

Timeline

Start

2020-06-01

Primary completion

2023-11-01

Completion

2025-01-18

Publications

• Background van Haren FMP, Page C, Laffey JG, Artigas A, Camprubi-Rimblas M, Nunes Q, Smith R, Shute J, Carroll M, Tree J, Carroll M, Singh D, Wilkinson T, Dixon B. Nebulised heparin as a treatment for COVID-19: scientific rationale and a call for randomised evidence. Crit Care. 2020 Jul 22;24(1):454. doi: 10.1186/s13054-020-03148-2.
• 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. Efficacy of inhaled nebulised unfractionated heparin to prevent intubation or death in hospitalised patients with COVID-19: an investigator-initiated international meta-trial of randomised clinical studies. EClinicalMedicine. 2025 Sep 27;88:103339. doi: 10.1016/j.eclinm.2025.103339. eCollection 2025 Oct.
• van Haren FMP, Richardson A, Yoon HJ, Artigas A, Laffey JG, Dixon B, Smith R, Vilaseca AB, Barbera RA, Ismail TI, Mahrous RS, Badr M, De Nucci G, Sverdloff C, van Loon LM, Camprubi-Rimblas M, Cosgrave DW, Smoot TL, Staas S, Sann K, Sas C, Belani A, Hillman C, Shute J, Carroll M, Wilkinson T, Carroll M, Singh D, Page C. 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. Br J Clin Pharmacol. 2021 Aug;87(8):3075-3091. doi: 10.1111/bcp.14714. Epub 2021 Jan 19.

Drugs

Indications