The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
People who become infected with a virus such as SARS-CoV-2 usually develop an immune response and produce antibodies against the virus. Antibodies are natural proteins made by the body's immune system that attack viruses and other germs. These antibodies are found in plasma, which is the yellow, clear part of the blood. There have been other studies using plasma to treat other types of viruses that showed some positive results. Human plasma containing antibodies to the SARS-CoV-2 virus is an option for prevention and treatment of COVID-19. This type of treatment, known as passive antibody therapy, could be rapidly available when there are sufficient numbers of people who have recovered from infection and can donate antibody-containing plasma. In contrast to vaccination strategies, which begin to provide protection weeks after administration, antibody-containing plasma would provide its protective benefits immediately. Additionally, passive antibody therapy may be the only way to provide immunity for some immunocompromised patients who do not respond to vaccines. This research will evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma). The research will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320. The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
Johns Hopkins Hospitals
Baltimore, Maryland, United States
Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events
Number of subjects with grade 3 and 4 adverse events during the study period.
Time frame: 28 days
Number of Subjects With Disease Worsening Event
Disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death.
Time frame: 28 days
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers
Anti-SARS-CoV-2 antibody titer changes. Recipient titers 30 minutes after plasma.
Time frame: 30 minutes
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time
Half lives based on totality of data
Time frame: at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.
Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection
Presence or absence of endogenous anti-SARS-CoV-2 antibody titers.
Time frame: up to 2 months
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