Expanded Access to Convalescent Plasma for Treatment of COVID-19
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This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center 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.
Condition or disease
Biological: Convalescent Plasma
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center 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 enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Age at least 18 years
Laboratory confirmed diagnosis of infection with SARS-CoV-2
Admitted to the hospital for the treatment of COVID-19 complications
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
Informed consent provided by the patient or healthcare proxy
Severe COVID-19 is defined by one or more of the following:
respiratory frequency ≥ 30/min
blood oxygen saturation ≤ 93%
partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
lung infiltrates > 50% within 24 to 48 hours
Life-threatening COVID-19 is defined as one or more of the following: