Nebulized Heparin for COVID19-associated Acute Respiratory Failure

NCT ID: NCT04842292

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2021-09-04

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebulized heparin

Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Nebulized heparin 25,000 units every 6 hours

Nebulized placebo

Sodium chloride 0.9% 5 mL inhalation every 6 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sodium chloride 0.9% every 6 hours

Interventions

Heparin

Nebulized heparin 25,000 units every 6 hours

Intervention Type: DRUG

Placebo

Sodium chloride 0.9% every 6 hours

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brittany Bissell

OTHER

Sponsor Role: lead

Responsible Party

Brittany Bissell

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brittany D Bissell

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

UK Healthcare

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

65139

Identifier Type: -

Identifier Source: org_study_id