Convalescent Plasma in Pediatric COVID-19

NCT04458363 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00000789
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

COVID-19; Pediatric; Convalescent Plasma; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in percent of supplemental oxygen

  Baseline, 72 hours after infusion

• Number of patients that required change in level of respiratory support

  Baseline, 72 hours after infusion

• Mortality

  up to 1 year

• Mean length of ICU stay (days)

  Up to 28 days

• Mean length of hospital stay (days)

  Up to 28 days

Study Arms (1)

Convalescent Plasma (CP)

EXPERIMENTAL

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

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

Interventions

Convalescent Plasma (CP) 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.

Convalescent Plasma (CP)

Standard COVID-19 therapies 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.

Convalescent Plasma (CP)

Eligibility Criteria

• Age: 0 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy/ breast feeding
• Medical condition that increases the risk of plasma infusion
• Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
• 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.
• Pregnancy/ breast feeding
• Medical condition that increases the risk of plasma infusion
• Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Preeti Jaggi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: July 4, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)