Back to resultsCovid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
Primary Purpose
Corona Virus Infection
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-SARS-CoV-2 human convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection
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:
- 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.
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.
Sites / Locations
- University of California, Los Angeles (UCLA)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-SARS-CoV-2 human convalescent plasma
Arm Description
single transfusion of human convalescent plasma
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT04462848
First Posted
June 30, 2020
Last Updated
July 7, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04462848
Brief Title
Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
Official Title
Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-SARS-CoV-2 human convalescent plasma
Arm Type
Experimental
Arm Description
single transfusion of human convalescent plasma
Intervention Type
Biological
Intervention Name(s)
anti-SARS-CoV-2 human convalescent plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative incidence of Grade 3 and Grade 4 adverse events
Description
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.
Time Frame
up to Day 28 post-administration of study plasma
Title
Cumulative incidence of serious adverse events
Description
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.
Time Frame
up to Day 28 post-administration of study plasma
Secondary Outcome Measure Information:
Title
Proportion of participants with disease worsening event.
Description
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.
Time Frame
up to Day 28 post-administration of study plasma
Title
Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies
Description
Anti-SARS-CoV-2 antibody titer changes over time
Time Frame
Days 0, 7, 14, and 28
Title
Percentage of participants with a natural antibody response to SARS-CoV-2 infection
Description
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
Time Frame
once between Day 60 and Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime G Deville, M.D.
Phone
310-825-9660
Email
jdeville@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime G Deville, M.D.
Organizational Affiliation
UCLA Clinical Professor of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime G Deville, M.D.
Phone
310-825-9660
Email
jdeville@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Michele F Carter, R.N.
Phone
310-206-6369
Email
mfcarter@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
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