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.
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.
Biological: Convalescent Plasma
Fresh or frozen plasma will be infused one time to patients with COVID-19 infection
Inclusion Criteria:
1. Age at least 18 years
2. Laboratory confirmed diagnosis of infection with SARS-CoV-2
3. Admitted to the hospital for the treatment of COVID-19 complications
4. 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
5. Informed consent provided by the patient or healthcare proxy
6. Severe COVID-19 is defined by one or more of the following:
- dyspnea
- 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:
- respiratory failure/mechanical ventilation
- septic shock
- multiple organ dysfunction or failure
Hackensack University Medical Center
Hackensack, New Jersey, United States
Michele Donato, Principal Investigator
Hackensack Meridian Health