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CompletedNCT04635241INHALE-HEPUpdated Jun 17, 2025

Inhaled Heparin for Hospitalised COVID-19 Patients

A Phase 2/3 interventional study of Unfractionated heparin in Covid19, sponsored by Australian National University. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Australian National University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2020, registered Nov 2020).
Phase
Phase 2/3
Study type
Interventional
Enrollment
485
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 485 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Australian National University is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
485 participants (actual)

Study arms

  • 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

  • No intervention
    Standard care

    Standard care

Interventions

  • DrugUnfractionated heparin

    Inhaled nebulised 6 hourly

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What researchers measure

Primary outcomes

  1. Intubation rate

    Proportion of patients requiring invasive mechanical ventilation

    Time frame: Day 28

Secondary outcomes

  1. WHO ordinal scale COVID19

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

    Time frame: Day 7

  2. Oxygenation

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

    Time frame: Day 7

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Study locations

5 sites
  • San Camilo Clinic
    Buenos Aires, Argentina
  • 15th May hospital
    Cairo, Egypt
  • RS Universitas Indonesia
    Depok, Indonesia
  • RSUP Dr Cipto Mangunkusumo
    Jakarta, Indonesia
  • RSUD Dr Moewardi
    Surakarta, Indonesia
08

References and documents

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. PubMed 32698853 ↗
  • 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. PubMed 33377218 ↗

Individual participant data

Plan to share: Undecided — This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04635241
Lead sponsor
Australian National University
Collaborators
Helwan University, Clinica San Camilo, Argentina, Frederick Health, Dr Cipto Mangunkusumo General Hospital, Dr. Moewardi General Hospital, Surakarta, Indonesia, University of Sao Paulo, St James Connolly Memorial Hospital, University College Hospital Galway, Beaumont Hospital
Responsible party
Frank van Haren (Professor, Australian National University) — Principal investigator
First posted
Nov 19, 2020
Start date
Jun 1, 2020
Primary completion
Nov 1, 2023
Completion
Jan 18, 2025
Last update
Jun 17, 2025

Study contacts

Frank MP van Haren, MD, PhD
study chair · Australian National University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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