Inhaled Heparin for Hospitalised COVID-19 Patients

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: Unfractionated heparin

• Registration Number: NCT04635241
• Lead Sponsor: Australian National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-19
• Primary Completion: 2023-11-01
• Status Verified: 2025-01
• Study Completion: 2025-01-18
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled heparin	Unfractionated heparin	Inhaled nebulised unfractionated heparin in addition to standard care Dose 25,000 IU every 6 hours for up to 21 days

Primary Outcome Measures

Name	Time	Method
Intubation rate	Day 28	Proportion of patients requiring invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

15th May hospital; 🇪🇬 Cairo, Egypt

San Camilo Clinic; 🇦🇷 Buenos Aires, Argentina

RSUD Dr Moewardi; 🇮🇩 Surakarta, Indonesia

RS Universitas Indonesia; 🇮🇩 Depok, Indonesia

RSUP Dr Cipto Mangunkusumo; 🇮🇩 Jakarta, Indonesia