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Convalescent Plasma in Pediatric COVID-19

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ClinicalTrials.gov Identifier: NCT04458363
Recruitment Status : Completed
First Posted : July 7, 2020
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Preeti Jaggi, Emory University

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.

Condition or disease Intervention/treatment Phase
COVID Biological: Convalescent Plasma (CP) Drug: Standard COVID-19 therapies Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
Actual Study Start Date : July 4, 2020
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: Convalescent Plasma (CP)
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
Biological: Convalescent Plasma (CP)
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.

Drug: Standard COVID-19 therapies
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 Measures :
  1. Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion [ Time Frame: 28 days ]
    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 :
  1. Change in percent of supplemental oxygen [ Time Frame: Baseline, 72 hours after infusion ]
    Change in percent of supplemental oxygen within 72 hours after infusion

  2. Number of patients that required change in level of respiratory support [ Time Frame: Baseline, 72 hours after infusion ]
    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)

  3. Mortality [ Time Frame: up to 1 year ]
    Number of deaths

  4. Mean length of ICU stay (days) [ Time Frame: Up to 28 days ]
    Length of ICU stay (days) will be recorded

  5. Mean length of hospital stay (days) [ Time Frame: Up to 28 days ]
    Length of hospital stay (days) will be recorded

  6. Mean length of ventilation (days) [ Time Frame: Up to 28 days ]
    Length of ventilation (days) will be recorded

  7. Number of patients with progression to renal dysfunction and/or multisystem organ failure [ Time Frame: up to 1 year ]
    Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded

  8. IL-6 level [ Time Frame: up to 28 days ]
    Cytokine milieu will be assayed by Luminex

  9. Number of anti-SARS CoV 2 specific T cells [ Time Frame: up to 28 days ]
    Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells

  10. Diversity of circulating T cells [ Time Frame: up to 28 days ]
    Cellular studies will be used for evaluation of diversity of circulating T cells

  11. ARS-CoV-2 Antibody Titer [ Time Frame: up to 28 days ]
    Antibody titers to SARS-CoV-2 evaluation will be performed in vivo

  12. SARS-CoV-2 Neutralizing Titer [ Time Frame: up to 28 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458363


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Preeti Jaggi, MD Emory University
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Responsible Party: Preeti Jaggi, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04458363    
Other Study ID Numbers: STUDY00000789
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Preeti Jaggi, Emory University:
COVID-19
Pediatric
Convalescent Plasma
Safety