Convalescent Plasma in Pediatric COVID-19

COVID Clinical Trial

Official title:

Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458363
• Other study ID #: STUDY00000789
• Status: Completed
• Phase: Early Phase 1
• Start date: July 4, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 22 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion	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)	28 days
Secondary	Change in percent of supplemental oxygen	Change in percent of supplemental oxygen within 72 hours after infusion	Baseline, 72 hours after infusion
Secondary	Number of patients that required change in level of respiratory support	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)	Baseline, 72 hours after infusion
Secondary	Mortality	Number of deaths	up to 1 year
Secondary	Mean length of ICU stay (days)	Length of ICU stay (days) will be recorded	Up to 28 days
Secondary	Mean length of hospital stay (days)	Length of hospital stay (days) will be recorded	Up to 28 days
Secondary	Mean length of ventilation (days)	Length of ventilation (days) will be recorded	Up to 28 days
Secondary	Number of patients with progression to renal dysfunction and/or multisystem organ failure	Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded	up to 1 year
Secondary	IL-6 level	Cytokine milieu will be assayed by Luminex	up to 28 days
Secondary	Number of anti-SARS CoV 2 specific T cells	Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells	up to 28 days
Secondary	Diversity of circulating T cells	Cellular studies will be used for evaluation of diversity of circulating T cells	up to 28 days
Secondary	ARS-CoV-2 Antibody Titer	Antibody titers to SARS-CoV-2 evaluation will be performed in vivo	up to 28 days
Secondary	SARS-CoV-2 Neutralizing Titer	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.	up to 28 days