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Convalescent Plasma in Pediatric COVID-19

Primary Purpose

COVID

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma (CP)
Standard COVID-19 therapies
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring COVID-19, Pediatric, Convalescent Plasma, Safety

Eligibility Criteria

0 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 0 to 22 years of age
  • SARS-CoV-2 infection documented by RNA RT-PCR detection
  • Admitted to an acute care facility
  • Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived

Exclusion Criteria:

  • Pregnancy/ breast feeding
  • Medical condition that increases the risk of plasma infusion
  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).

Inclusion criteria for infusion:

  • Severe COVID-19 disease, OR
  • Moderate disease with a risk of progression to severe or life threatening disease, OR
  • Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care.

Exclusion to infusion:

  • Pregnancy/ breast feeding
  • Medical condition that increases the risk of plasma infusion
  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).

Sites / Locations

  • Children's Healthcare of Atlanta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Convalescent Plasma (CP)

Arm Description

Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered

Outcomes

Primary Outcome Measures

Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)

Secondary Outcome Measures

Change in percent of supplemental oxygen
Change in percent of supplemental oxygen within 72 hours after infusion
Number of patients that required change in level of respiratory support
Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)
Mortality
Number of deaths
Mean length of ICU stay (days)
Length of ICU stay (days) will be recorded
Mean length of hospital stay (days)
Length of hospital stay (days) will be recorded
Mean length of ventilation (days)
Length of ventilation (days) will be recorded
Number of patients with progression to renal dysfunction and/or multisystem organ failure
Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
IL-6 level
Cytokine milieu will be assayed by Luminex
Number of anti-SARS CoV 2 specific T cells
Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
Diversity of circulating T cells
Cellular studies will be used for evaluation of diversity of circulating T cells
ARS-CoV-2 Antibody Titer
Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
SARS-CoV-2 Neutralizing Titer
Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.

Full Information

First Posted
June 25, 2020
Last Updated
November 13, 2021
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04458363
Brief Title
Convalescent Plasma in Pediatric COVID-19
Official Title
Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 4, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
Detailed Description
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID
Keywords
COVID-19, Pediatric, Convalescent Plasma, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma (CP)
Arm Type
Experimental
Arm Description
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma (CP)
Intervention Description
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.
Intervention Type
Drug
Intervention Name(s)
Standard COVID-19 therapies
Intervention Description
If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.
Primary Outcome Measure Information:
Title
Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
Description
Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change in percent of supplemental oxygen
Description
Change in percent of supplemental oxygen within 72 hours after infusion
Time Frame
Baseline, 72 hours after infusion
Title
Number of patients that required change in level of respiratory support
Description
Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)
Time Frame
Baseline, 72 hours after infusion
Title
Mortality
Description
Number of deaths
Time Frame
up to 1 year
Title
Mean length of ICU stay (days)
Description
Length of ICU stay (days) will be recorded
Time Frame
Up to 28 days
Title
Mean length of hospital stay (days)
Description
Length of hospital stay (days) will be recorded
Time Frame
Up to 28 days
Title
Mean length of ventilation (days)
Description
Length of ventilation (days) will be recorded
Time Frame
Up to 28 days
Title
Number of patients with progression to renal dysfunction and/or multisystem organ failure
Description
Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
Time Frame
up to 1 year
Title
IL-6 level
Description
Cytokine milieu will be assayed by Luminex
Time Frame
up to 28 days
Title
Number of anti-SARS CoV 2 specific T cells
Description
Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
Time Frame
up to 28 days
Title
Diversity of circulating T cells
Description
Cellular studies will be used for evaluation of diversity of circulating T cells
Time Frame
up to 28 days
Title
ARS-CoV-2 Antibody Titer
Description
Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
Time Frame
up to 28 days
Title
SARS-CoV-2 Neutralizing Titer
Description
Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 0 to 22 years of age SARS-CoV-2 infection documented by RNA RT-PCR detection Admitted to an acute care facility Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived Exclusion Criteria: Pregnancy/ breast feeding Medical condition that increases the risk of plasma infusion Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). Inclusion criteria for infusion: Severe COVID-19 disease, OR Moderate disease with a risk of progression to severe or life threatening disease, OR Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care. Exclusion to infusion: Pregnancy/ breast feeding Medical condition that increases the risk of plasma infusion Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Jaggi, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Convalescent Plasma in Pediatric COVID-19

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