Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Brittany Bissell

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Heparin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04842292

65139

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups, including a placebo group

Nebulized heparin

Experimental group

Description:

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

Treatment:

Drug: Heparin

Nebulized placebo

Placebo Comparator group

Description:

Sodium chloride 0.9% 5 mL inhalation every 6 hours

Treatment:

Drug: Placebo