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.
Biological: Anti-SARS-CoV-2 Human Convalescent Plasma
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.
Inclusion Criteria:
- Between 1 month and 18 years of age at the time of consent.
- Determined to be at high-risk for severe SARS-CoV-2 disease based on the American
Academy of Pediatrics definition of immunocompromised children and reported high-risk
Pediatric subpopulations. These include the following groups: Immunocompromised,
Hemodynamically significant cardiac disease {e.g. congenital heart disease}, Lung
disease with chronic respiratory failure, Medically complex children defined as
children who have a long-term dependence on technological support (including
tracheotomy) associated with developmental delay and/or genetic anomalies21, Obesity,
Infant, i.e. child ≤1 year old.
- Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:
1. Confirmed infection: Child who tested positive for COVID-19 and is no more than
168 hours after onset of symptoms (and within 192 hours at the time of receipt of
plasma).
2. High-risk exposure: Susceptible child who was not previously infected or
otherwise immune to SARS-CoV-2 and exposed within 96 hours prior to enrollment
(and within 120 hours at the time of receipt of plasma). Both criteria below
should be met: A household member or daycare center (same room) exposure to a
person with [confirmed SARS-CoV-2 OR with clinically compatible disease in
regions with widespread ongoing transmission] and a negative for SARS-CoV-2
(nasopharyngeal swab)
- Subject is judged by the investigator to have the initiative and means to be compliant
with the protocol.
- Subjects or their legal representatives must have the ability to read, understand, and
provide written informed consent for the initiation of any study related procedures.
Exclusion Criteria:
- History of severe reactions (e.g. anaphylaxis) to transfusion of blood products.
Subjects with minor reactions such as fever, itching, chills, etc. that resolve
spontaneously or respond to pre-medications, and that do not represent more
significant allergic reactions will not be excluded.
- Inability to complete therapy with the study product within the stipulated time frame
outlined above
- Female subjects in child-bearing age with a positive pregnancy test, breastfeeding, or
planning to become pregnant/breastfeed during the study period.
- Subject / caregiver deemed by the study team to be non-compliant with the study
protocol
Johns Hopkins Hospitals
Baltimore, Maryland, United States
Sanjay K Jain, MD, Principal Investigator
Johns Hopkins University