Convalescent Plasma in Pediatric COVID-19

• ClinicalTrials.gov Identifier: NCT04458363
• Recruitment Status: Completed
• First Posted: July 7, 2020
• Last Update Posted: January 19, 2021
• Sponsor: Emory University
• Information provided by (Responsible Party): Preeti Jaggi, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID	Biological: Convalescent Plasma (CP); Drug: Standard COVID-19 therapies	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
• Actual Study Start Date: July 4, 2020
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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

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.

Outcome Measures

Primary Outcome Measures :

1. Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion [ Time Frame: 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 :

1. Change in percent of supplemental oxygen [ Time Frame: Baseline, 72 hours after infusion ]
   Change in percent of supplemental oxygen within 72 hours after infusion
2. Number of patients that required change in level of respiratory support [ Time Frame: 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)
3. Mortality [ Time Frame: up to 1 year ]
   Number of deaths
4. Mean length of ICU stay (days) [ Time Frame: Up to 28 days ]
   Length of ICU stay (days) will be recorded
5. Mean length of hospital stay (days) [ Time Frame: Up to 28 days ]
   Length of hospital stay (days) will be recorded
6. Mean length of ventilation (days) [ Time Frame: Up to 28 days ]
   Length of ventilation (days) will be recorded
7. Number of patients with progression to renal dysfunction and/or multisystem organ failure [ Time Frame: up to 1 year ]
   Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
8. IL-6 level [ Time Frame: up to 28 days ]
   Cytokine milieu will be assayed by Luminex
9. Number of anti-SARS CoV 2 specific T cells [ Time Frame: up to 28 days ]
   Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
10. Diversity of circulating T cells [ Time Frame: up to 28 days ]
    Cellular studies will be used for evaluation of diversity of circulating T cells
11. ARS-CoV-2 Antibody Titer [ Time Frame: up to 28 days ]
    Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
12. SARS-CoV-2 Neutralizing Titer [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: up to 22 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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).

Contacts and Locations

Locations

United States, Georgia

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: Preeti Jaggi, MD; Emory University

More Information

• Responsible Party: Preeti Jaggi, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT04458363
• Other Study ID Numbers: STUDY00000789
• First Posted: July 7, 2020
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Preeti Jaggi, Emory University:

COVID-19; Pediatric; Convalescent Plasma; Safety