Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
485 participants
INTERVENTIONAL
2020-06-01
2025-01-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19)
NCT05184101
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children
NCT05204550
Enriched Heparin Anti COVID-19 Trial
NCT04743011
Nebulized Heparin for the Treatment of COVID-19
NCT04723563
Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
NCT04385186
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inhaled heparin
Inhaled nebulised unfractionated heparin in addition to standard care Dose 25,000 IU every 6 hours for up to 21 days
Unfractionated heparin
Inhaled nebulised 6 hourly
Standard care
Standard care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Unfractionated heparin
Inhaled nebulised 6 hourly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helwan University
OTHER
Clinica San Camilo, Argentina
OTHER
Frederick Health
OTHER
Dr Cipto Mangunkusumo General Hospital
OTHER
Dr. Moewardi General Hospital, Surakarta, Indonesia
OTHER
University of Sao Paulo
OTHER
St James Connolly Memorial Hospital
OTHER
University College Hospital Galway
OTHER
Beaumont Hospital
OTHER
Australian National University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Frank van Haren
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank MP van Haren, MD, PhD
Role: STUDY_CHAIR
Australian National University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INHALE-HEP meta-trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.