Convalescent Plasma in Pediatric COVID-19

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University

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).