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Convalescent Plasma in Pediatric COVID-19

NCT04458363 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-11-22

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Preeti Jaggi, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-04
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458363 on ClinicalTrials.gov