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Lack of enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized heparin | Experimental | Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours |
|
| Nebulized placebo | Placebo Comparator | Sodium chloride 0.9% 5 mL inhalation every 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Nebulized heparin 25,000 units every 6 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean PaO2/FiO2 Ratio | Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first |
| 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 |
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Inclusion Criteria:
Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brittany D Bissell | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Healthcare | Lexington | Kentucky | 40536 | United States |
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Two participants were enrolled. To protect privacy, data will not be presented for each arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean PaO2/FiO2 Ratio | 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. | Posted | Mean | Standard Deviation | units on a scale | Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brittany Bissell | University of Kentucky | 8593239308 | bdbi223@uky.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 31, 2022 | Oct 17, 2022 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo |
| Drug |
Sodium chloride 0.9% every 6 hours |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Clinically Significant Bleeding | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to discharge or 3 months following enrollment, whichever occurs first |
|
|
|
| Secondary | Incidence of Venous Thromboembolism | 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. | Posted | Number | Incidence | Up to discharge or 3 months following enrollment, whichever occurs first |
|
|
|
| 1 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |