Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Jaime G Deville, M.D.
Data sourced from clinicaltrials.gov
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