Clinical trial NCT04635241: Inhaled Heparin for Hospitalised COVID-19 Patients
Official title: INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Australian National University
Sponsor class: OTHER
Collaborators: name: Helwan University
name: Clinica San Camilo, Argentina
name: Frederick Health
name: Dr Cipto Mangunkusumo General Hospital
name: Dr. Moewardi General Hospital, Surakarta, Indonesia
name: University of Sao Paulo
name: St James Connolly Memorial Hospital
name: University College Hospital Galway
name: Beaumont Hospital
First posted: 2020-11-19
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Intubation rate
timeFrame: Day 28
Secondary outcomes:
measure: WHO ordinal scale COVID19
timeFrame: Day 7
measure: Oxygenation
timeFrame: Day 7
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: San Camilo Clinic
city: Cairo
country: Egypt
facility: 15th May hospital
city: Depok
country: Indonesia
facility: RS Universitas Indonesia
city: Jakarta
country: Indonesia
facility: RSUP Dr Cipto Mangunkusumo
city: Surakarta
country: Indonesia
facility: RSUD Dr Moewardi
Study officials:
affiliation: Australian National University
name: Frank MP van Haren, MD, PhD
role: STUDY_CHAIR
References:
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.
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.