Convalescent Plasma in Pediatric COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Biological: Convalescent Plasma (CP); Drug: Standard COVID-19 therapies

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent of supplemental oxygen	Change in percent of supplemental oxygen within 72 hours after infusion	Baseline, 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)	Baseline, 72 hours after infusion
Mortality	Number of deaths	up to 1 year
Mean length of ICU stay (days)	Length of ICU stay (days) will be recorded	Up to 28 days
Mean length of hospital stay (days)	Length of hospital stay (days) will be recorded	Up to 28 days
Mean length of ventilation (days)	Length of ventilation (days) will be recorded	Up to 28 days
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	up to 1 year
IL-6 level	Cytokine milieu will be assayed by Luminex	up to 28 days
Number of anti-SARS CoV 2 specific T cells	Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells	up to 28 days
Diversity of circulating T cells	Cellular studies will be used for evaluation of diversity of circulating T cells	up to 28 days
ARS-CoV-2 Antibody Titer	Antibody titers to SARS-CoV-2 evaluation will be performed in vivo	up to 28 days
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.	up to 28 days

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Preeti Jaggi, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Pediatric; COVID-19; Convalescent Plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STUDY00000789

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