Convalescent Plasma in Pediatric COVID-19

Emory University

Status and phase: Completed; Early Phase 1

Conditions: COVID

Treatments: Drug: Standard COVID-19 therapies; Biological: Convalescent Plasma (CP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04458363

STUDY00000789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Convalescent Plasma (CP)

Experimental group

Description:

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

Treatment:

Biological: Convalescent Plasma (CP)

Drug: Standard COVID-19 therapies