Covid19
Conditions
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.
Interventions
DRUGHeparin
Nebulized heparin 25,000 units every 6 hours
DRUGPlacebo
Sodium chloride 0.9% every 6 hours
Sponsors
Brittany Bissell
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean PaO2/FiO2 Ratio | Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Recruitment details
Two participants were enrolled. To protect privacy, data will not be presented for each arm.
Participants by arm
| Arm | Count |
|---|---|
| Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Mean PaO2/FiO2 Ratio
Time frame: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants | Mean PaO2/FiO2 Ratio | NA units on a scale |
Secondary
Clinically Significant Bleeding
Time frame: Up to discharge or 3 months following enrollment, whichever occurs first
Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants | Clinically Significant Bleeding | NA units on a scale |
Secondary
Incidence of Venous Thromboembolism
Time frame: Up to discharge or 3 months following enrollment, whichever occurs first
Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Incidence of Venous Thromboembolism | NA Incidence |