Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Heparin

• Registration Number: NCT04842292
• Lead Sponsor: Brittany Bissell

Brief Summary

The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-13
• Study Start: 2021-05-20
• Primary Completion: 2021-09-04
• Study Completion: 2021-09-04
• Results First Submitted: 2022-09-21
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Results First Posted: 2022-10-18
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours

Exclusion Criteria

• Allergy to heparin
• Any history of heparin-induced thrombocytopenia
• High risk of bleeding (platelet count < 50,000/µL or international normalized ratio > 1.5)
• Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
• Active bleeding
• Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
• Neurosurgical procedures during this hospital admission or such procedures are planned
• Epidural catheter in place
• Any history of intracranial, spinal or epidural hemorrhage
• Tracheostomy in place
• Cervical spinal cord injury associated with reduced long-term ability to breathe independently
• Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
• Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
• Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
• Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
• Pregnant or might be pregnant.
• Objection from the treating clinician
• Consent refused by the patient or substitute decision maker.
• History of thrombosis (VTE or cardiovascular event)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nebulized placebo	Placebo	Sodium chloride 0.9% 5 mL inhalation every 6 hours
Nebulized heparin	Heparin	Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours

Primary Outcome Measures

Name	Time	Method
Mean PaO2/FiO2 Ratio	Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Clinically Significant Bleeding	Up to discharge or 3 months following enrollment, whichever occurs first
Incidence of Venous Thromboembolism	Up to discharge or 3 months following enrollment, whichever occurs first

Trial Locations

Locations (1)

UK Healthcare; 🇺🇸 Lexington, Kentucky, United States