Convalescent Plasma for the Treatment of COVID-19

Thomas Jefferson University52 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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

Time frame: 0, 1, 2, 3, 7, 14 days

Length of hospital stay

Days of hospitalization

Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days

Length of Intensive Care Unit stay

Days of Intensive Care Unit management

Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days

Length of intubation

Days of intubation requirement

Time frame: 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

Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days

Changes in complete blood count in patients after receiving convalescent plasma