INHALE-HEP: Inhaled Heparin for Hospitalised COVID-19 Patients

Sponsor

Australian National University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04635241

Collaborator

Helwan University (Other), Clinica San Camilo, Argentina (Other), Frederick Health (Other), Coney Island Hospital, Brooklyn, NY (Other), Galeno Desenvolvimento de Pesquisas Clínicas (Other)

712

Enrollment

Locations

Arms

Anticipated Duration (Months)

356

Patients Per Site

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Unfractionated heparin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

712 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inhaled heparin Inhaled nebulised unfractionated heparin in addition to standard care Dose 25,000 IU every 6 hours for up to 21 days	Drug: Unfractionated heparin Inhaled nebulised 6 hourly
No Intervention: Standard care Standard care

Arm

Intervention/Treatment

Experimental: Inhaled heparin

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

Drug: Unfractionated heparin

Inhaled nebulised 6 hourly

No Intervention: Standard care

Standard care

Outcome Measures

Primary Outcome Measures

Intubation rate [Day 28]
Proportion of patients requiring invasive mechanical ventilation

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Camilo Clinic	Buenos Aires		Argentina
2	15th May hospital	Cairo		Egypt

Sponsors and Collaborators

Australian National University
Helwan University
Clinica San Camilo, Argentina
Frederick Health
Coney Island Hospital, Brooklyn, NY
Galeno Desenvolvimento de Pesquisas Clínicas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Review.

Responsible Party:

Frank van Haren, Professor, Australian National University

ClinicalTrials.gov Identifier:

NCT04635241

Other Study ID Numbers:

INHALE-HEP meta-trial

First Posted:

Nov 19, 2020

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Heparin

Calcium heparin

Study Results

No Results Posted as of Feb 16, 2022