Inhaled Heparin for Hospitalised COVID-19 Patients

Covid19 Clinical Trial

— INHALE-HEP  

Official title:

INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04635241
• Other study ID #: INHALE-HEP meta-trial
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Australian National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 485
• Est. completion date: June 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Unfractionated heparin
Inhaled nebulised 6 hourly

Locations

Country	Name	City	State
Argentina	San Camilo Clinic	Buenos Aires
Egypt	15th May hospital	Cairo
Indonesia	RS Universitas Indonesia	Depok
Indonesia	RSUP Dr Cipto Mangunkusumo	Jakarta
Indonesia	RSUD Dr Moewardi	Surakarta

Sponsors (8)

Lead Sponsor	Collaborator
Australian National University	Clinica San Camilo, Argentina, Coney Island Hospital, Brooklyn, NY, Dr Cipto Mangunkusumo General Hospital, Dr. Moewardi General Hospital, Surakarta, Indonesia, Frederick Health, Galeno Desenvolvimento de Pesquisas Clínicas, Helwan University

Countries where clinical trial is conducted

Argentina,  Egypt,  Indonesia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate	Proportion of patients requiring invasive mechanical ventilation	Day 28
Secondary	WHO ordinal scale COVID19	Number of patients showing 1 or 2 point worsening on the ordinal scale	Day 7
Secondary	Oxygenation	Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2)	Day 7