Convalescent Plasma for the Treatment of COVID-19
- Conditions
- COVID-19
- Interventions
- Drug: Convalescent Plasma
- Registration Number
- NCT04389710
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
- Detailed Description
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Age 18 years and older
- Laboratory confirmed diagnosis of SARS-CoV-2
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Informed consent provided by patient or legally authorized representative
- Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
Severe Disease defined as any of the following
- Dyspnea
- Respiratory rate > 30/minute
- Oxygen saturation <94%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
- Lung infiltrates >50% within 24 to 48 hours
Life-threatening disease defined as any of the following
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group Convalescent Plasma Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
- Primary Outcome Measures
Name Time Method Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2 1 year Number of patients who are consented and ultimately receive convalescent plasma transfusion.
- Secondary Outcome Measures
Name Time Method Changes in prothrombin time (PT) in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Survival to discharge 0, 1, 2, 3, 7, 14, 28, 60, and 90 days Proportion of patients who are successfully discharged from acute care facility
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Length of hospital stay 0, 1, 2, 3, 7, 14, 28, 60, and 90 days Days of hospitalization
Length of Intensive Care Unit stay 0, 1, 2, 3, 7, 14, 28, 60, and 90 days Days of Intensive Care Unit management
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma 0 and 7 days BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Length of intubation 0, 1, 2, 3, 7, 14, 28, 60, and 90 days Days of intubation requirement
Changes in complete blood count in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in d-dimer in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in fibrinogen in patients after receiving convalescent plasma 0 and 7 days Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19 0, 1, 2, 3, 7, 14 days Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States