Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Study Overview
=================
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.

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

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Heparin
* Drug: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized heparin<br>Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours | Drug: Heparin<br>* Nebulized heparin 25,000 units every 6 hours<br>|
| Placebo Comparator: Nebulized placebo<br>Sodium chloride 0.9% 5 mL inhalation every 6 hours | Drug: Placebo<br>* Sodium chloride 0.9% every 6 hours<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean PaO2/FiO2 Ratio |  | Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |