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Inhaled Heparin for Hospitalised COVID-19 Patients (INHALE-HEP)

Primary Purpose

Covid19

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Unfractionated heparin

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

San Camilo ClinicRecruiting
15th May hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inhaled heparin

Standard care

Arm Description

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

Standard care

Outcomes

Primary Outcome Measures

Intubation rate

Proportion of patients requiring invasive mechanical ventilation

Secondary Outcome Measures

WHO ordinal scale COVID19

Number of patients showing 1 or 2 point worsening on the ordinal scale

Oxygenation

Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2)

Full Information

NCT ID

NCT04635241

First Posted

November 14, 2020

Last Updated

January 31, 2023

Sponsor

Australian National University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04635241

Brief Title

Inhaled Heparin for Hospitalised COVID-19 Patients

Acronym

INHALE-HEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Australian National University

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

712 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inhaled heparin

Arm Type

Experimental

Arm Description

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

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Standard care

Intervention Type

Drug

Intervention Name(s)

Unfractionated heparin

Intervention Description

Inhaled nebulised 6 hourly

Primary Outcome Measure Information:

Title

Intubation rate

Description

Proportion of patients requiring invasive mechanical ventilation

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

WHO ordinal scale COVID19

Description

Number of patients showing 1 or 2 point worsening on the ordinal scale

Time Frame

Day 7

Title

Oxygenation

Description

Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2)

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frank MP van Haren, MD, PhD

Phone

+61467051809

frank.vanharen@anu.edu.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank MP van Haren, MD, PhD

Organizational Affiliation

Australian National University

Official's Role

Study Chair

Facility Information:

Facility Name

San Camilo Clinic

City

Buenos Aires

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alicia B Vilaseca, PhD

avilaseca@clinicasancamilo.org.ar

Facility Name

15th May hospital

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarek I Ismail

Phone

00201001467166

drtarek.anesth@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies.

Citations:

PubMed Identifier

32698853

Citation

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.

Results Reference

background

PubMed Identifier

33377218

Citation

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.

Results Reference

derived

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Inhaled Heparin for Hospitalised COVID-19 Patients

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