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NCT Number: NCT04635241

Inhaled Heparin for Hospitalised COVID-19 Patients

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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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

San Camilo Clinic, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfractionated heparin

Drug

Inhaled nebulised 6 hourly

Primary outcomes

  1. Intubation rate

    Time frame: Day 28

    Proportion of patients requiring invasive mechanical ventilation

Secondary outcomes

  1. WHO ordinal scale COVID19

    Time frame: Day 7

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

  2. Oxygenation

    Time frame: Day 7

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

Sponsors and collaborators

Lead sponsor

Australian National University

Other

Collaborators

  • Beaumont Hospital
  • Clinica San Camilo, Argentina
  • Dr Cipto Mangunkusumo General Hospital
  • Dr. Moewardi General Hospital, Surakarta, Indonesia
  • Frederick Health
  • Helwan University
  • St James Connolly Memorial Hospital
  • University College Hospital Galway
  • University of Sao Paulo

Registry information

Official study title

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

Acronym: INHALE-HEP

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Nov 19, 2020
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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