Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

NCT ID: NCT04462848

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2024-12-31

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.

Conditions

Corona Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti-SARS-CoV-2 human convalescent plasma

single transfusion of human convalescent plasma

Group Type: EXPERIMENTAL

anti-SARS-CoV-2 human convalescent plasma

Intervention Type: BIOLOGICAL

Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.

Interventions

anti-SARS-CoV-2 human convalescent plasma

Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jaime G. Deville, MD, FAAP

Clinical Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaime G Deville, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCLA Clinical Professor of Pediatrics

Locations

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Countries

United States

Central Contacts

Jaime G Deville, M.D.

Role: CONTACT

jdeville@mednet.ucla.edu

310-825-9660

Facility Contacts

Jaime G Deville, M.D.

Role: primary

jdeville@mednet.ucla.edu

310-825-9660

Michele F Carter, R.N.

Role: backup

mfcarter@mednet.ucla.edu

310-206-6369

Other Identifiers

IRB#20-001263

Identifier Type: -

Identifier Source: org_study_id