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Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heparin
Placebo
Sponsored by
Brittany Bissell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • UK Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nebulized heparin

Nebulized placebo

Arm Description

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

Sodium chloride 0.9% 5 mL inhalation every 6 hours

Outcomes

Primary Outcome Measures

Mean PaO2/FiO2 Ratio

Secondary Outcome Measures

Clinically Significant Bleeding
Incidence of Venous Thromboembolism

Full Information

First Posted
April 8, 2021
Last Updated
October 17, 2022
Sponsor
Brittany Bissell
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1. Study Identification

Unique Protocol Identification Number
NCT04842292
Brief Title
Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Official Title
Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 4, 2021 (Actual)
Study Completion Date
September 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brittany Bissell

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebulized heparin
Arm Type
Experimental
Arm Description
Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours
Arm Title
Nebulized placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% 5 mL inhalation every 6 hours
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Nebulized heparin 25,000 units every 6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride 0.9% every 6 hours
Primary Outcome Measure Information:
Title
Mean PaO2/FiO2 Ratio
Time Frame
Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
Secondary Outcome Measure Information:
Title
Clinically Significant Bleeding
Time Frame
Up to discharge or 3 months following enrollment, whichever occurs first
Title
Incidence of Venous Thromboembolism
Time Frame
Up to discharge or 3 months following enrollment, whichever occurs first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany D Bissell
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
UK Healthcare
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nebulized Heparin for COVID19-associated Acute Respiratory Failure

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