This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Following the administration of one unit (approximately 200 mL) of convalescent plasma over
one hour, the study proposes to determine the therapeutic efficacy (response rate) of
convalescent plasma infusion in patients at high risk for mortality when infected by
SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19
during the current hospitalization as determined by evaluating if the patient experienced the
following the following: respiratory rate >30/min, Blood oxygen saturation <93%, partial
pressure of arterial oxygen to fraction of inspired oxygen ration <300, or received a medical
diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This
will be captured from the daily physical exam/clinical assessment done as part of routine
care and at discharge.
The study also proposes to determine the immunologic effects of convalescent plasma infusion
as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at
enrollment, day 7 and discharge.
Finally, the study intends to measure normalization of laboratory parameters for risk which
will be documented every 3 days while the patient is hospitalized until the time that lab
value returns to within the institution's normal range.
Biological: Convalescent Plasma
Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
Inclusion Criteria:
- Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
- Patients must also have the following indications for enrollment:
- i. D-Dimer > 500 ng/ml FEU OR
- ii. IL-6> 5 pg/mL
With any of the following:
- iii. Lymphocytes < 0.8 103/ul OR
- iv. LDH > 700 U/L OR
- v. CK > 170 U/L OR
- vi. CRP > 1.0 mg/dl OR
- vii. Ferritin > 1000 ng/ml
AND one of the following:
- viii. Age over 60 years
- ix. Underlying Active Malignancy
- x. Cardiovascular Disease
- xi. Active Tobacco Use
- xii. History of Pulmonary Volume Reduction Surgery
- xiii. Hypertension
- Prior Treatment: Patients are still eligible for this trial if active antimicrobial
agents are in use. Patients are also eligible if they had been treated on COVID-19
clinical trial in the course of their disease.
- Age ≥ 18 years.
- The effects of allogeneic plasma infusion on the developing fetus is unknown. For this
reason women who are pregnant are not eligible to participate.
- Agrees to required laboratory data collected which will include the baseline organ
function and regular ongoing assessments done as part of routine care.
- Ability to understand and the willingness to sign a written informed consent document
or ability to have consent provided by Legally Authorized Representative.
Exclusion Criteria:
- 4.2.1 Patients who do not meet above inclusion criteria are not eligible.
- 4.2.2 Patients may not be receiving any other investigational agents.
- 4.2.3 History of allergic reactions attributed to previous transfusion history.
- 4.2.4 Respiratory rate >30/min
- 4.2.5 Blood oxygen saturation <93%
- 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration <300
- 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ
dysfunction/failure
Norton Hospital
Louisville, Kentucky, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Norton Audubon Hospital
Louisville, Kentucky, United States
Norton Brownsboro Hospital
Louisville, Kentucky, United States
Joseph M Flynn, DO, MPH
502-272-5001
Joseph.flynn@nortonhealthcare.org
Marti Gardner, MSN, APRN
502-629-3550
Marti.Gardner@nortonhealthcare.org
Joseph M Flynn, DO, MPH, Principal Investigator
Norton Healthcare