Status:
COMPLETED
Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
Lead Sponsor:
Johns Hopkins University
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04377672
Start Date
May 28 2020
End Date
December 13 2021
Last Update
March 27 2024
Active Locations (1)
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1
Johns Hopkins Hospitals
Baltimore, Maryland, United States, 21287