Clinical trial NCT04458363: Convalescent Plasma in Pediatric COVID-19
Official title: Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COVID
Keywords: COVID-19
Pediatric
Convalescent Plasma
Safety
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 3
Sex: ALL
Minimum age (years): 0
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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).

Primary outcomes:
measure: Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
timeFrame: 28 days
Secondary outcomes:
measure: Change in percent of supplemental oxygen
timeFrame: Baseline, 72 hours after infusion
measure: Number of patients that required change in level of respiratory support
timeFrame: Baseline, 72 hours after infusion
measure: Mortality
timeFrame: up to 1 year
measure: Mean length of ICU stay (days)
timeFrame: Up to 28 days
measure: Mean length of hospital stay (days)
timeFrame: Up to 28 days
measure: Mean length of ventilation (days)
timeFrame: Up to 28 days
measure: Number of patients with progression to renal dysfunction and/or multisystem organ failure
timeFrame: up to 1 year
measure: IL-6 level
timeFrame: up to 28 days
measure: Number of anti-SARS CoV 2 specific T cells
timeFrame: up to 28 days
measure: Diversity of circulating T cells
timeFrame: up to 28 days
measure: ARS-CoV-2 Antibody Titer
timeFrame: up to 28 days
measure: SARS-CoV-2 Neutralizing Titer
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Preeti Jaggi, MD
role: PRINCIPAL_INVESTIGATOR
References: