Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19)

NCT05184101 | Withdrawn Phase 2 DMC

• 1 other identifier: INHALE-HEP Australia Version 3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Investigator-initiated, multi-centre, randomised, open-label trial of nebulised heparin sodium in addition to standard care compared to standard care alone in hospitalised patients with COVID-19 infection.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Intubation

  The primary outcome is intubation (or death, for patients who died before intubation) before or at day 28 after randomisation.

  28 days

Secondary Outcomes (3)

• Mortality

  60 days

• Oxygenation

  28 days

• Length of hospitalisation

  60 days

Other Outcomes (3)

• Ventilator free days

  60 days

• Length of Intensive Care Unit admission

  60 days

• Incidence of bleeding

  Day 21

Study Arms (2)

Nebulised heparin

EXPERIMENTAL

Participants assigned to 'nebulised heparin' will receive nebulised heparin in addition to the standard care required as determined by the treating team.

Drug: Unfractionated Heparin

Standard care

NO INTERVENTION

Participants assigned to 'standard care' will receive the standard care required as determined by the treating team and will not be treated with nebulised heparin.

Interventions

Unfractionated Heparin DRUG

Heparin sodium will be administered as a nebulised aerosol dose of 25,000 IU heparin three times a day (TDS) via an Aerogen Solo (Aerogen, Ireland) vibrating mesh aerosol drug nebulizer.

Also known as: Heparin

Nebulised heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Currently admitted to hospital
• There is a positive sample for COVID-19 within the past 14 days. The sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient
• Requiring oxygenation according to the modified ordinal clinical scale 4-5

You may not qualify if:

• Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment
• Heparin allergy or heparin-induced thrombocytopaenia
• Activated partial thromboplastin time (APTT) \> 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma
• Platelet count \< 20 x 10\^9 per L within 48 hours of randomisation
• Pulmonary bleeding or uncontrolled bleeding within 48 hours of randomisation
• Known or suspected pregnancy
• Acute brain injury that may result in long-term disability
• Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome
• Treatment limitations in place, i.e. not for intubation, not for ICU admission
• Death is imminent or inevitable within 24 hours
• Clinician objection
• Participant consent declined

Sponsors & Collaborators

• Australian National University: lead
• The George Institute: collaborator
• St George Hospital, Australia: collaborator
• St Vincent's Hospital Melbourne: collaborator
• John Hunter Hospital: collaborator
• Royal North Shore Hospital: collaborator

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Related Publications (2)

• 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.

  PMID: 32698853 BACKGROUND

• 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.

  PMID: 33377218 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Frank MP van Haren, PhD

  Australian National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: investigator-initiated, multi-centre, randomised, open-label trial

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 11, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: real-time

Locations

AU (1)