Convalescent Plasma for the Treatment of COVID-19

Completed · Phase 2

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04389710

Run by

Thomas Jefferson University

People needed

52

Starts

2020-04-15

Expected to finish

2020-12-07

Last updated by the study team

2021-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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