Convalescent Plasma for the Treatment of COVID-19

Thomas Jefferson University

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04389710

20D.379

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Intervention Group

Experimental group

Description:

Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr

Treatment:

Drug: Convalescent Plasma