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Completed

NCT Number: NCT04458363

Convalescent Plasma in Pediatric COVID-19

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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Key information

Conditions

COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Convalescent Plasma (CP)

Biological

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.

Standard COVID-19 therapies

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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