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This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma.
NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.
Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recovered from the very same infection that another person is infected with. This plasma is enriched in the antibodies that recognize and helped the body's immune system fight off the infection. When transfused from donor to recipient those antibodies will aid the recipient in fighting off the infection. In recent history this has been used to fight Ebola. Recently, the Federal Food and Drug Agency (FDA) made possible expedited Investigational New Drug (IND) process for plasma use in the fight against COVID19 for emergency and lifesaving uses.
There are several other investigational drugs for treatment of COVID19 such as: Remdesivir, an antiviral. The off-label use of hydroxychloroquine, Lopinavir/ritonavir, or Tocilizumab have been authorized. Convalescent plasma mechanism of action helps to promote health by working with one's own immune system and will not interfere with the other proposed medications. It also will not weaken the immune system as the investigational and off label medications have the potential to do. Convalescent plasma is time honored and although investigational for each use against novel or rare infections, it is the basis for IgG infusions in the immunodeficient populations. Currently the use of IgG infusions such as Intravenous IgG (IVIG) is assumed to not have the right antibodies from donors in the general public. This is secondary to the novel nature of the COVID19 and the fact that the IVIG available today was collected 6 to 12 months ago from plasma donors; prior to the COVID19's outbreak discovery in China.
It is for that reason that IVIG is not recommended at this time and the FDA has made special fast-tracking announcements for plasma use for COVID19. Currently, plasma is the only treatment that has a previous history of success in these novel or rare viral outbreak situations. It has already been reported to have been associated with survival of 5 out of 5 participants in a pilot study in China
For the purpose of this study advanced respiratory support will include any measure of respiratory support above low flow nasal cannula oxygen (2 Liters/minute flow rate).
For the purpose of this study dyspnea will be defined as any shortness of breath that is not completely relieved with the use of low flow nasal canula oxygen set to 2 Liters/minute flow rate and/or requiring breathing treatments such as but not limited to: bronchodilators more than every 4 hours to relieve symptoms.
In the event that more than one recipient is identified and plasma is available in less than the total number of approved recipients, priority will be given to those approved by the FDA for the IND use of plasma for severe or critical condition. If there still exists a deficit of plasma, the priority will be given to those on advanced respiratory support with the most critical settings (if unclear then will be considered a tie); active pressor treatments; age <1 years of age with days of life, age adjusted for prematurity as a tie breaker; age >60 with years as a tie breaker; and lastly lottery pull with potential remaining recipients as the final tie breaker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma | Experimental | Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. An additional unit of plasma will be given every 3 days up to 8 units if patient was not improving or getting worse. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Meeting Infusion Criteria to Infusion | Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days. | up to 30 days |
| Plasma Recipient Survival | Number of participants who were alive 30 days after hospital discharge. | 30 days from discharge |
| Identify Plasma Donor | Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days | 365 days |
| Outreach to Plasma Donor | Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days | 365 days |
| Plasma Donor Time Until Donated | Time until plasma is donated Measured every 24 hours up to 1 year | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Recipient Mortality | Number of mortalities within those that enrolled in the study. | Up to 1 year |
| Plasma Recipient LOS | Length of Stay in hospital. Measured every day until patient discharged from hospital up to 1 year |
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Inclusion Criteria: (NOTE: It is important to note that West Virginia, as a state, does not have any entity with the required FDA registration or licensure, nor the necessary on-site equipment, to collect convalescent plasma for the purpose of plasma transfusion. Therefore, the plasma donation portion of this study was not completed).
Plasma donation:
Prior diagnosis of COVID-19 documented by a laboratory test
Complete resolution of symptoms at least 28 days prior to donation
Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
Female donors age 18+ that have never been pregnant or negative for HLA antibodies
Male donors age 18+
Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
At least or greater than 50kg of weight
Plasma Recipients:
Exclusion Criteria:
Plasma donation:
Plasma Recipients
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| Name | Affiliation | Role |
|---|---|---|
| Brian Peppers, DO, PhD | WVU Medicine Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine | Morgantown | West Virginia | 26506 | United States |
This study enrolled plasma recipients only. No plasma donors were enrolled as study participants. West Virginia does not have a single entity with FDA registration/licensure and the required on-site equipment to collect convalescent plasma for transfusion. Although donor-related operational steps were included in the initial protocol, donor recruitment and collection were not performed. Stored convalescent plasma from external suppliers was used.
Recipients were hospitalized patients who received convalescent plasma under protocol-defined eligibility criteria during the COVID-19 pandemic period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Convalescent Plasma | Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Hospitalized recipients with confirmed COVID-19 who met protocol-defined infusion criteria were included in the Baseline population. Race and ethnicity were not collected from any participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Convalescent Plasma | Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time of Meeting Infusion Criteria to Infusion | Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days. | Posted | Mean | Full Range | days | up to 30 days |
|
1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
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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 | Convalescent Plasma | Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transfusion-associated circulatory overload (TACO) | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
The plasma donor component of the original protocol was withdrawn due to lack of FDA-licensed plasma collection capability in West Virginia. West Virginia, as a State, does not have a single entity that has the FDA registration or licensure and the equipment on site required to collect plasma for the purpose of plasma transfusion. Therefore, donor-related outcomes have zero participants enrolled or analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian P. Peppers , DO, PhD | West Virginia University | 304-594-1313 | brian.peppers@hsc.wvu.edu |
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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 | Jun 25, 2020 | Apr 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2019 | Apr 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| up to 1 year |
| Plasma Recipient AE (Day 1) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 1) post infusion. [Safety and Tolerability] | Day 1 |
| Plasma Recipient AE (Day 2) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 2) post infusion. [Safety and Tolerability] | Day 2 |
| Plasma Recipient AE (Day 3) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 3) post infusion. [Safety and Tolerability] | Day 3 |
| Plasma Recipient AE (Day 4) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 4) post infusion. [Safety and Tolerability] | Day 4 |
| Plasma Recipient AE (Day 5) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 5) post infusion. [Safety and Tolerability] | Day 5 |
| Plasma Recipient AE (Day 6) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 6) post infusion. [Safety and Tolerability] | Day 6 |
| Plasma Recipient AE (Day 7) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 7) post infusion. [Safety and Tolerability] | Day 7 |
| Plasma Recipient AE (Day 30) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 30) of follow up post infusion [Safety and Tolerability] | Day 30 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Plasma Recipient Survival | Number of participants who were alive 30 days after hospital discharge. | Posted | Count of Participants | Participants | 30 days from discharge |
|
|
|
| Secondary | Plasma Recipient Mortality | Number of mortalities within those that enrolled in the study. | Posted | Number | number of deaths | Up to 1 year |
|
|
|
| Secondary | Plasma Recipient LOS | Length of Stay in hospital. Measured every day until patient discharged from hospital up to 1 year | Posted | Mean | Full Range | Days | up to 1 year |
|
|
|
| Secondary | Plasma Recipient AE (Day 1) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 1) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 1 |
|
|
|
| Secondary | Plasma Recipient AE (Day 2) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 2) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 2 |
|
|
|
| Secondary | Plasma Recipient AE (Day 3) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 3) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 3 |
|
|
|
| Secondary | Plasma Recipient AE (Day 4) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 4) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 4 |
|
|
|
| Secondary | Plasma Recipient AE (Day 5) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 5) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 5 |
|
|
|
| Secondary | Plasma Recipient AE (Day 6) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 6) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 6 |
|
|
|
| Secondary | Plasma Recipient AE (Day 7) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 7) post infusion. [Safety and Tolerability] | Posted | Number | Events | Day 7 |
|
|
|
| Secondary | Plasma Recipient AE (Day 30) | Number of treatment-emergent adverse events recorded among recipients on this study day (Day 30) of follow up post infusion [Safety and Tolerability] | Posted | Number | Events | Day 30 |
|
|
|
| Primary | Identify Plasma Donor | Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days | The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled. | Posted | 365 days |
|
|
| Primary | Outreach to Plasma Donor | Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days | The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled. | Posted | 365 days |
|
|
| Primary | Plasma Donor Time Until Donated | Time until plasma is donated Measured every 24 hours up to 1 year | The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled. | Posted | up to 1 year |
|
|
| 22 |
| 117 |
| 16 |
| 117 |
| 34 |
| 117 |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Extracorporeal Membrane Oxygenation (ECMO) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Distress requiring intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax requiring chest tube | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal Compartment Syndrome | General disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| pruritus | Hepatobiliary disorders | Non-systematic Assessment |
|
| Pulmonary Vascular Congestions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bilateral infiltrates | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory Distress (BIPAP) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Addition of Nitric Oxide/Increase in Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Transfusion-associated circulatory overload (TACO) | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Transfusion related acute lung injury (TRALI) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Transfusion-associated dyspnea (TAD) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Embolism (PE) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute kidney injury (AKI) | Renal and urinary disorders | Non-systematic Assessment |
|
| Abscess | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Healthcare-associated pneumonia (HCAP) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Stool Impaction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Intubated | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Respiratory Distress Low Flow Nasal Cannula (LFNC) to High Flow Nasal Cannula (HFNC) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |