Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)

Completed · Phase 1

Conditions studied: SARS-CoV-2 Infection

In brief

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.

Key facts

Study ID

NCT04377672

Run by

Johns Hopkins University

People needed

14

Starts

2020-05-28

Expected to finish

2021-12-13

Last updated by the study team

2024-03-27

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospitals — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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