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New information regarding use of plasma in covid + patients
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The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical Patients | Other |
| |
| Severe Patients | Other |
| |
| High Risk | Other |
| |
| Health Care Providers | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | Number of patients who survived the covid infection after treatment on study. | 30 days after initial treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent Holland, MD | Northside Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
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Enrollment period 7/14/2020-9/13/2021 Subjects were recruited from the hospital, outpatient clinic and from marketing efforts
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| ID | Title | Description |
|---|---|---|
| FG000 | Critical Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| FG001 | Severe Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| FG002 | High Risk | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| FG003 | Health Care Providers | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No critical patients were consented for this study
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| ID | Title | Description |
|---|---|---|
| BG000 | Critical Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| BG001 | Severe Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| 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 | Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | Number of patients who survived the covid infection after treatment on study. | no critical patients were enrolled. | Posted | Count of Participants | Participants | 30 days after initial treatment |
|
30 days
8 patients assessed
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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 | Critical Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Kent Holland, MD | Northside Hospital | 404-255-1930 | kholland@bmtga.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2020 | Nov 23, 2021 | Prot_SAP_000.pdf |
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| BG002 | High Risk | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| BG003 | Health Care Providers | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High Risk | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
| OG003 | Health Care Providers | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Severe Patients | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | High Risk | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Health Care Providers | Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 0 | 1 | 0 | 1 | 0 | 1 |
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