Convalescent Plasma in Pediatric COVID-19

Early Phase 1CompletedNCT04458363

Emory University3 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID

Interventions

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 therapiesDRUG

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.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 22 Years

Medical Language ↔ Plain English

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).

Locations (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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)

Time frame: 28 days

Secondary Outcomes

Change in percent of supplemental oxygen

Change in percent of supplemental oxygen within 72 hours after infusion

Time frame: 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)

Time frame: Baseline, 72 hours after infusion

Mortality

Number of deaths

Time frame: up to 1 year

Mean length of ICU stay (days)

Length of ICU stay (days) will be recorded

Time frame: Up to 28 days

Mean length of hospital stay (days)

Length of hospital stay (days) will be recorded

Time frame: Up to 28 days

Mean length of ventilation (days)

Length of ventilation (days) will be recorded

Time frame: Up to 28 days

Data from ClinicalTrials.gov

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