Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Sponsor

Brittany Bissell (Other)

Overall Status

Recruiting

CT.gov ID

NCT04842292

Collaborator

(none)

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Heparin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean PaO2/FiO2 ratio [Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UK Healthcare	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

Brittany Bissell

Investigators

Principal Investigator: Brittany D Bissell, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brittany Bissell, Assistant Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT04842292

Other Study ID Numbers:

65139

First Posted:

Apr 13, 2021

Last Update Posted:

Jun 15, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Respiratory Insufficiency

Heparin

Study Results

No Results Posted as of Jun 15, 2021