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

NCT04462848 | Unknown Phase 1 FDA Drug

• 1 other identifier: IRB#20-001263
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of Grade 3 and Grade 4 adverse events

  A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated. A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.

  up to Day 28 post-administration of study plasma

• Cumulative incidence of serious adverse events

  A serious adverse event is any untoward or unfavorable medical occurrence that: * results in death, * is life-threatening, * requires inpatient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect, or * is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

  up to Day 28 post-administration of study plasma

Secondary Outcomes (3)

• Proportion of participants with disease worsening event.

  up to Day 28 post-administration of study plasma

• Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies

  Days 0, 7, 14, and 28

• Percentage of participants with a natural antibody response to SARS-CoV-2 infection

  once between Day 60 and Day 120

Study Arms (1)

anti-SARS-CoV-2 human convalescent plasma

EXPERIMENTAL

single transfusion of human convalescent plasma

Biological: anti-SARS-CoV-2 human convalescent plasma

Interventions

anti-SARS-CoV-2 human convalescent plasma 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.

anti-SARS-CoV-2 human convalescent plasma

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jaime G Deville, M.D.

  UCLA Clinical Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime G Deville, M.D.

CONTACT

310-825-9660; jdeville@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Pediatrics

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 8, 2020
• Study Start: August 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)