Convalescent Plasma for the Treatment of COVID-19

Study Overview
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Brief Summary
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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
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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).

Official Title
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Convalescent Plasma for the Treatment of Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr | Drug: Convalescent Plasma<br>* One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2 | Number of patients who are consented and ultimately receive convalescent plasma transfusion. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19 | Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection | 0, 1, 2, 3, 7, 14 days | 
| Length of hospital stay | Days of hospitalization | 0, 1, 2, 3, 7, 14, 28, 60, and 90 days | 
| Length of Intensive Care Unit stay | Days of Intensive Care Unit management | 0, 1, 2, 3, 7, 14, 28, 60, and 90 days | 
| Length of intubation | Days of intubation requirement | 0, 1, 2, 3, 7, 14, 28, 60, and 90 days | 
| Survival to discharge | Proportion of patients who are successfully discharged from acute care facility | 0, 1, 2, 3, 7, 14, 28, 60, and 90 days | 
| Changes in complete blood count in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days | 
| Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma | 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). | 0 and 7 days | 
| Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days | 
| Changes in d-dimer in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days | 
| Changes in fibrinogen in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days | 
| Changes in prothrombin time (PT) in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days | 
| Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma | Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner). | 0 and 7 days |