Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma
 for pediatric patients with underlying medical conditions (cardiovascular disease, lung
 disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a
 high-risk exposure. Study participants will be transfused once with compatible convalescent
 plasma obtained from an individual who has recovered from documented infection with
 SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Inclusion Criteria:

 -  Age ≥ 1 month and < 18 years 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, infant, i.e. child ≤1 year old.

 -  Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:

 -  Confirmed infection: Child who tested positive for COVID-19 and is no more than
 96 hours after onset of symptoms (and within 120 hours at the time of receipt of
 study plasma).

 -  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 study plasma). Both criteria
 below should be met:

 1. A household member or daycare center (same room) exposure to a person with
 confirmed SARS-CoV-2 OR with clinically compatible disease in areas with
 widespread ongoing transmission

 2. Negative for SARS-CoV-2 (nasopharyngeal or oropharyngeal swab)

 -  For females of reproductive potential (defined as having experienced menarche), not
 pregnant based on testing performed at screening.

 -  Parent or legal guardian able and willing to provide signed parent permission.

 Exclusion Criteria:

 -  History of severe reactions (e.g. anaphylaxis) to transfusion of blood products.
 Individuals 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.

 -  For females, breastfeeding, or planning to become pregnant/breastfeed during the study
 period.

 -  Participant is unlikely to adhere to the study procedures, keep appointments, or is
 planning to relocate outside the greater Los Angeles area during the study.

 -  Any condition that would, in the opinion of the principal investigator, place the
 participant at an unacceptable risk of injury or render the participant unable to meet
 the requirements of the protocol.