The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
The purpose of this research study is to see if convalescent plasma is safe and effective for
the treatment of patients acutely ill with COVID-19. The researchers want to confirm the
right dose levels of immunoglobulins/antibodies (immune proteins) and find out what
therapeutic effects plasma donated by recovered individuals has on people severely sick with
COVID-19.
Biological: Convalescent plasma transfusion
Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
Phase 1 Inclusion Criteria:
Inclusion Criteria for Convalescent Plasma Donors:
- Outpatients 18 years old and older who have recovered from COVID-19:
- Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
- Complete resolution of symptoms at least 14 days prior to donation
- Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
- Able to meet standard criteria for blood donation
- Clinically stable based on provider assessment
Phase 1 Exclusion Criteria:
Exclusion criteria:
- Inability to complete or contraindication to donation based on Donor History -
- Questionnaire (DHQ), FDA approved standard blood donation form
- Hb<13.0 g/dL for males
- Hb<12.5 g/dL for females
- History of 3 more pregnancies unless HLA antibody testing is performed and deemed
acceptable by director of blood donor services (to reduce risks of transfusion Related
Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases
is based on history or test results from blood sample collected from the donor at time
of plasma collection in accordance to standard practice.
- Female subjects who are pregnant by self-report.
- Receipt of pooled immunoglobulin in past 30 days
PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:
- Patients in the Inova Health System with confirmed COVID-19 by PCR testing
- Age ≥ 13 years
- Currently hospitalized with COVID-19 infection with severe or life-threatening
clinical syndrome as follows:
- Severe COVID-19: (three or more of the following)
- Dyspnea
- Respiratory rate ≥ 30/min
- Blood oxygen saturation (SpO2) ≤ 94% on room air
- Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio <
300
- Pulmonary infiltrates > 50% of lung parenchyma within 24 to 48 hours
- Life-threatening disease is defined as: (one of the following)
- Respiratory failure
- Septic shock, and/or
- Multiple organ dysfunction or failure
- Patient must provide informed consent or have health care power of attorney/next of
kin provide consent if he/she cannot.
PHASE 2 Exclusion Criteria:
- Contraindication to receive plasma as deemed by the treating physician
- Severe hypercoagulable state (documented in medical chart or by treating physician
assessment)
- Absolute IgA deficiency
- Prior history of Transfusion Related Acute Lung Injury (TRALI)
- Inability to tolerate plasma volume due to severe systolic or diastolic heart failure
despite slower infusion and diuretic administration
- Positive pregnancy test (HCG)
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Anne Brown, M.D., Principal Investigator
Inova Health Care Services