The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.
Biological: anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours
Donor Inclusion Criteria:
- Age greater or equal to 18
- Able to donate blood per blood bank standard guidelines
- Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
- Complete resolution of symptoms at least 28 days prior to donation
- Female donors who have never been pregnant, previously pregnant female donors negative
for HLA antibodies (HLA screening), or male donors
Donor Exclusion Criteria:
- Does not provide consent
- Does not meet standard blood bank donation guidelines
- Unsuccessful blood donation
Recipient Inclusion Criteria:
- Patients must be 18 years of age or older
- Must have laboratory-confirmed COVID-19
- Must have severe or immediately life-threatening COVID-19
- Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen
saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired
oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
- Life-threatening defined as respiratory failure, septic shock, and/or multiple
organ dysfunction or failure. Lower priority should be given to patients with
septic shock or multiple organ dysfunction or failure since their disease may
have progressed to a point where they are not able to benefit from convalescent
plasma therapy.
- Must be less than 21 days from the start of illness
- Patient is willing and able to provide written informed consent and comply with all
protocol requirements. If the patient is not able to consent, we will obtain consent
from the power of attorney or a health care proxy for the patient as determined by the
Illinois Healthcare Surrogate Act
- Patient, power of attorney or health care proxy agrees to storage of specimens for
future testing.
- Of note, eIND application for each recipient subject will need to be approved before
administration of convalescent plasma
Recipient Exclusion Criteria:
- Female subjects with positive pregnancy test, breastfeeding, or planning to become
pregnant/breastfeed during the study period
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood
products
- Patients currently enrolled in other drug trials that preclude investigational
treatment with anti-SARS-CoV-2 convalescent plasma
University of Chicago Medicine
Chicago, Illinois, United States
Maria Lucia Madariaga, MD, Principal Investigator
University of Chicago Biological Sciences Division Department of Surgery