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.
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.
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).
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Preeti Jaggi, MD, Principal Investigator
Emory University