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Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear.
Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia.
Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate > 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio < 300 mm Hg; and bilateral airspace opacities on chest x-ray > 50% within 24 to 48 hours.
Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids.
Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma Intervention | Experimental | Convalescent plasma 200mL transfusion |
|
| Standard Therapy Control | No Intervention | Standard therapy for COVID-19 disease as defined by institutional protocols |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma | Biological | One 200mL transfusion of ABO compatible convalescent plasma over 3 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Disease Severity | Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion | day 3 post transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | Total ICU length of stay | Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated. |
| Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geneva Tatem, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Convalescent Plasma Intervention | Convalescent plasma 200mL transfusion Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours |
| FG001 | Standard Therapy Control | Standard therapy for COVID-19 disease as defined by institutional protocols |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Convalescent Plasma Intervention | Convalescent plasma 200mL transfusion Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours |
| BG001 | Standard Therapy Control |
| 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 | Change in Respiratory Disease Severity | Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion | Posted | Mean | Standard Deviation | ratio | day 3 post transfusion |
|
28 days
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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 | Intervention | Convalescent plasma 200mL transfusion Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Geneva Tatem | Henry Ford Health System | 313-916-2431 | gtatem1@hfhs.org |
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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 | May 4, 2020 | Aug 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Randomized control trial
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Hospital length of stay
| Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated. |
| Ventilator Days | Duration of time on ventilator | 28 day |
| Number of Participants With Transfusion Adverse Events | Adverse transfusion events after 1 unit of convalescent plasma | From transfusion up to 1 day post-transfusion |
| Normal Chest X Ray at 28 Days | Change in Chest X Ray Findings | 28 days |
| All-cause Mortality | All-cause overall deaths at end of trial at 28 days | 28 days |
Standard therapy for COVID-19 disease as defined by institutional protocols
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity categories as defined by the National Institutes of Health/Office of Management and Budget (NIH/OMB) Standards | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race categories as defined by the National Institutes of Health/Office of Management and Budget (NIH/OMB) Standards | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dyspnea with Respiratory Rate (RR) >30 | Number of participants with a respiratory rate >30 at randomization | Count of Participants | Participants |
|
| SaO2/FiO2 | The ratio of oxygen saturation by pulse oximeter (SaO2) to oxygen concentration (FiO2) | Mean | Standard Deviation | ratio |
|
| Bilateral airspace opacities on CXR >50% within 24 to 48 hours | Count of Participants | Participants |
|
| Mechanical ventilation | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | ICU Length of Stay | Total ICU length of stay | Posted | Median | Inter-Quartile Range | days | Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated. |
|
|
|
| Secondary | Length of Stay | Hospital length of stay | Posted | Median | Inter-Quartile Range | days | Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated. |
|
|
|
| Secondary | Ventilator Days | Duration of time on ventilator | Posted | Median | Inter-Quartile Range | days | 28 day |
|
|
|
| Secondary | Number of Participants With Transfusion Adverse Events | Adverse transfusion events after 1 unit of convalescent plasma | Posted | Number | participants | From transfusion up to 1 day post-transfusion |
|
|
|
| Secondary | Normal Chest X Ray at 28 Days | Change in Chest X Ray Findings | Normal CXR at 28 days | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | All-cause Mortality | All-cause overall deaths at end of trial at 28 days | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 3 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | Standard therapy for COVID-19 disease as defined by institutional protocols | 2 | 10 | 0 | 10 | 0 | 10 |
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| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |