Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Heparin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • UK HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized heparin; Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours	Drug: Heparin; Nebulized heparin 25,000 units every 6 hours
Placebo Comparator: Nebulized placebo; Sodium chloride 0.9% 5 mL inhalation every 6 hours	Drug: Placebo; Sodium chloride 0.9% every 6 hours

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Brittany Bissell
• Investigators: Principal Investigator: Brittany D Bissell, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): September 4, 2021
• Study Completion (Actual): September 4, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 65139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No