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

Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Corona Virus Infection
• Intervention / Treatment: Biological: anti-SARS-CoV-2 human convalescent plasma

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jaime G Deville, M.D.; Phone Number: 310-825-9660; Email: jdeville@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles (UCLA)
      • Contact: Jaime G Deville, M.D.; Phone Number: 310-825-9660; Email: jdeville@mednet.ucla.edu
      • Contact: Michele F Carter, R.N.; Phone Number: 310-206-6369; Email: mfcarter@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-SARS-CoV-2 human convalescent plasma; single transfusion of human convalescent plasma	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with disease worsening event.	Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.	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	Anti-SARS-CoV-2 antibody titer changes over time	Days 0, 7, 14, and 28
Percentage of participants with a natural antibody response to SARS-CoV-2 infection	This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration	once between Day 60 and Day 120

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Jaime G Deville, M.D., UCLA Clinical Professor of Pediatrics

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: IRB#20-001263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No