Convalescent Plasma in Pediatric COVID-19

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

July 4, 2020

Primary Completion Date

September 1, 2020

Study Completion Date

September 1, 2020

Conditions
COVID
Interventions
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.

Trial Locations (1)

30322

Children's Healthcare of Atlanta, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT04458363 - Convalescent Plasma in Pediatric COVID-19 | Biotech Hunter | Biotech Hunter