Nebulized Heparin for COVID19-associated Acute Respiratory Failure

NCT04842292 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 65139
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean PaO2/FiO2 Ratio

  Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first

Secondary Outcomes (2)

• 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

Study Arms (2)

Nebulized heparin

EXPERIMENTAL

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

Drug: Heparin

Nebulized placebo

PLACEBO COMPARATOR

Sodium chloride 0.9% 5 mL inhalation every 6 hours

Drug: Placebo

Interventions

Heparin DRUG

Nebulized heparin 25,000 units every 6 hours

Nebulized heparin

Placebo DRUG

Sodium chloride 0.9% every 6 hours

Nebulized placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Brittany Bissell: lead

Study Sites (1)

UK Healthcare

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Brittany Bissell
• Organization: University of Kentucky

bdbi223@uky.edu

8593239308

Study Officials

• Brittany D Bissell

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: May 20, 2021
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)