Clinical trial NCT04462848: Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
Official title: Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Corona Virus Infection
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of Grade 3 and Grade 4 adverse events
timeFrame: up to Day 28 post-administration of study plasma
measure: Cumulative incidence of serious adverse events
timeFrame: up to Day 28 post-administration of study plasma
Secondary outcomes:
measure: Proportion of participants with disease worsening event.
timeFrame: up to Day 28 post-administration of study plasma
measure: Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies
timeFrame: Days 0, 7, 14, and 28
measure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection
timeFrame: once between Day 60 and Day 120
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
Study officials:
affiliation: UCLA Clinical Professor of Pediatrics
name: Jaime G Deville, M.D.
role: PRINCIPAL_INVESTIGATOR
References: