Inhaled Heparin for Hospitalised COVID-19 Patients

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.

Conditions

• Covid19

Interventions

DRUG

Unfractionated heparin

Inhaled nebulised 6 hourly

Sponsors & Collaborators

• Helwan University

  collaborator OTHER

• Clinica San Camilo, Argentina

  collaborator OTHER

• Frederick Health

  collaborator OTHER

• Dr Cipto Mangunkusumo General Hospital

  collaborator OTHER

• Dr. Moewardi General Hospital, Surakarta, Indonesia

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• St James Connolly Memorial Hospital

  collaborator OTHER

• University College Hospital Galway

  collaborator OTHER

• Beaumont Hospital

  collaborator OTHER

• Australian National University

  lead OTHER

Principal Investigators

• Frank MP van Haren, MD, PhD · Australian National University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2023-11-01

Completion

2025-01-18

Countries

• Argentina
• Egypt
• Indonesia

Study Locations