Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04842292
• Other study ID #: 65139
• Status: Terminated
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: September 4, 2021

Study information

• Verified date: October 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 4, 2021
• Est. primary completion date: September 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiratory Insufficiency

Intervention

Drug:
• Heparin
Nebulized heparin 25,000 units every 6 hours
• Placebo
Sodium chloride 0.9% every 6 hours

Locations

Country	Name	City	State
United States	UK Healthcare	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Brittany Bissell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean PaO2/FiO2 Ratio		Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
Secondary	Clinically Significant Bleeding		Up to discharge or 3 months following enrollment, whichever occurs first
Secondary	Incidence of Venous Thromboembolism		Up to discharge or 3 months following enrollment, whichever occurs first