Convalescent Plasma in Pediatric COVID-19

NCT ID: NCT04458363

Last Updated: 2021-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-04
• Study Completion Date: 2020-09-01

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.

Conditions

COVID

Keywords

COVID-19; Pediatric; Convalescent Plasma; Safety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Convalescent Plasma (CP)

Intervention Type: BIOLOGICAL

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.

Standard COVID-19 therapies

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

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

• 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).

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).

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Preeti Jaggi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Preeti Jaggi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00000789

Identifier Type: -

Identifier Source: org_study_id