This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
This expanded access program provides hospitalized patients who are severely or
life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma
(CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care
specialists and Hospitalists identify appropriate patients in accordance with FDA
recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP
is obtained through New York Blood Center and American Red Cross in coordination with the
University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related
acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any
allergic reactions.Patients admitted to our institution prior to the availability of CCP will
be separately reviewed.
Biological: COVID-19 Convalescent Plasma
COVID-19 Convalescent Plasma from recovered COVID-19 patients transfusion into severely or life-threateningly ill COVID-19 infected patients
Inclusion Criteria:
1. Laboratory confirmed COVID-19.
2. Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of
the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen
saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired
oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b)
Life-threatening disease is defined as one or more of the following: i) respiratory
failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure
Exclusion Criteria:
1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to
blood products)
2. Severe multi-organ failure and hemodynamic instability requiring high doses of pressor
agents
3. Other documented uncontrolled infection
4. Severe DIC needing factor replacement, FFP, cryoprecipitate
5. Acute renal failure requiring dialysis
6. Active intracranial bleeding
7. Clinically significant myocardial ischemia
Rutgers New Jersey Medical School
Newark, New Jersey, United States
University Hospital
Newark, New Jersey, United States
Marc Klapholz, MD, MBA
973-972-4595
klapholz@njms.rutgers.edu
Khyati Mehta, MPH
973-972-6794
mehtakp@njms.rutgers.edu
Marc Klapholz, MD, MBA, Principal Investigator
Rutgers New Jersey Medical School; University Hospital