Phase 1
N=14
Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
SARS-CoV-2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04377672 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Anti-SARS-CoV-2 Human Convalescent Plasma (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events |
— | — |
| SECONDARY Number of Subjects With Disease Worsening Event |
— | — |
| SECONDARY Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers |
5.6 | — |
| SECONDARY Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time |
15.1 | — |
| SECONDARY Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection |
7 | — |
Summary
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.
Eligibility Criteria
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:
- 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).
- 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
Data sourced from ClinicalTrials.gov (NCT04377672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.