Convalescent Plasma in Pediatric COVID-19
- Conditions
- COVID
- Interventions
- Biological: Convalescent Plasma (CP)Drug: Standard COVID-19 therapies
- Registration Number
- NCT04458363
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Convalescent Plasma (CP) Convalescent Plasma (CP) Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered Convalescent Plasma (CP) Standard COVID-19 therapies Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
- Primary Outcome Measures
Name Time Method Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion 28 days Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)
- Secondary Outcome Measures
Name Time Method Change in percent of supplemental oxygen Baseline, 72 hours after infusion Change in percent of supplemental oxygen within 72 hours after infusion
Number of patients that required change in level of respiratory support Baseline, 72 hours after infusion Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)
Mortality up to 1 year Number of deaths
Mean length of ICU stay (days) Up to 28 days Length of ICU stay (days) will be recorded
Mean length of hospital stay (days) Up to 28 days Length of hospital stay (days) will be recorded
Mean length of ventilation (days) Up to 28 days Length of ventilation (days) will be recorded
Number of patients with progression to renal dysfunction and/or multisystem organ failure up to 1 year Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
IL-6 level up to 28 days Cytokine milieu will be assayed by Luminex
Number of anti-SARS CoV 2 specific T cells up to 28 days Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
Diversity of circulating T cells up to 28 days Cellular studies will be used for evaluation of diversity of circulating T cells
ARS-CoV-2 Antibody Titer up to 28 days Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
SARS-CoV-2 Neutralizing Titer up to 28 days Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.
Trial Locations
- Locations (1)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States