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Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)

Primary Purpose

SARS-CoV-2 Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Anti-SARS-CoV-2 Human Convalescent Plasma

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring convalescent, COVID-19, Coronavirus, plasma

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Between 1 month and 18 years of age at the time of consent.
Determined to be at high-risk for severe SARS-CoV-2 disease based on the American Academy of Pediatrics definition of immunocompromised children and reported high-risk Pediatric subpopulations. These include the following groups: Immunocompromised, Hemodynamically significant cardiac disease {e.g. congenital heart disease}, Lung disease with chronic respiratory failure, Medically complex children defined as children who have a long-term dependence on technological support (including tracheotomy) associated with developmental delay and/or genetic anomalies21, Obesity, Infant, i.e. child ≤1 year old.
Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:
1. Confirmed infection: Child who tested positive for COVID-19 and is no more than 168 hours after onset of symptoms (and within 192 hours at the time of receipt of plasma).
2. High-risk exposure: Susceptible child who was not previously infected or otherwise immune to SARS-CoV-2 and exposed within 96 hours prior to enrollment (and within 120 hours at the time of receipt of plasma). Both criteria below should be met: A household member or daycare center (same room) exposure to a person with [confirmed SARS-CoV-2 OR with clinically compatible disease in regions with widespread ongoing transmission] and a negative for SARS-CoV-2 (nasopharyngeal swab)
Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
Subjects or their legal representatives must have the ability to read, understand, and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Subjects with minor reactions such as fever, itching, chills, etc. that resolve spontaneously or respond to pre-medications, and that do not represent more significant allergic reactions will not be excluded.
Inability to complete therapy with the study product within the stipulated time frame outlined above
Female subjects in child-bearing age with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
Subject / caregiver deemed by the study team to be non-compliant with the study protocol

Sites / Locations

Johns Hopkins Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti- SARS-CoV-2 Plasma

Arm Description

Human Convalescent Plasma

Outcomes

Primary Outcome Measures

Safety of treatment with high-titer anti-SARS-CoV-2 plasma as assessed by adverse events

Proportion of subjects with grade 3 and 4 adverse events during the study period

Secondary Outcome Measures

Proportion of subjects with disease worsening event

Descriptive analysis of these outcomes, e.g. disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death

Pharmacokinetics of anti-SARS-CoV-2 antibodies as defined by changes in antibody titers

Anti-SARS-CoV-2 antibody titer changes

Proportion of subjects with a natural antibody response to SARS-CoV-2 infection

This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers. Antibody titer will be collected one time between 60-120 days.

Full Information

NCT ID

NCT04377672

First Posted

May 4, 2020

Last Updated

December 14, 2021

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT04377672

Brief Title

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)

Official Title

Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 28, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.

Detailed Description

People who become infected with a virus such as SARS-CoV-2 usually develop an immune response and produce antibodies against the virus. Antibodies are natural proteins made by the body's immune system that attack viruses and other germs. These antibodies are found in plasma, which is the yellow, clear part of the blood. There have been other studies using plasma to treat other types of viruses that showed some positive results. Human plasma containing antibodies to the SARS-CoV-2 virus is an option for prevention and treatment of COVID-19. This type of treatment, known as passive antibody therapy, could be rapidly available when there are sufficient numbers of people who have recovered from infection and can donate antibody-containing plasma. In contrast to vaccination strategies, which begin to provide protection weeks after administration, antibody-containing plasma would provide its protective benefits immediately. Additionally, passive antibody therapy may be the only way to provide immunity for some immunocompromised patients who do not respond to vaccines. This research will evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma). The research will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection

Keywords

convalescent, COVID-19, Coronavirus, plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anti- SARS-CoV-2 Plasma

Arm Type

Experimental

Arm Description

Human Convalescent Plasma

Intervention Type

Biological

Intervention Name(s)

Anti-SARS-CoV-2 Human Convalescent Plasma

Intervention Description

1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320. The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.

Primary Outcome Measure Information:

Title

Safety of treatment with high-titer anti-SARS-CoV-2 plasma as assessed by adverse events

Description

Proportion of subjects with grade 3 and 4 adverse events during the study period

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Proportion of subjects with disease worsening event

Description

Time Frame

28 days

Title

Pharmacokinetics of anti-SARS-CoV-2 antibodies as defined by changes in antibody titers

Description

Anti-SARS-CoV-2 antibody titer changes

Time Frame

Up to 28 days

Title

Proportion of subjects with a natural antibody response to SARS-CoV-2 infection

Description

This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers. Antibody titer will be collected one time between 60-120 days.

Time Frame

60-120 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 1 month and 18 years of age at the time of consent. Determined to be at high-risk for severe SARS-CoV-2 disease based on the American Academy of Pediatrics definition of immunocompromised children and reported high-risk Pediatric subpopulations. These include the following groups: Immunocompromised, Hemodynamically significant cardiac disease {e.g. congenital heart disease}, Lung disease with chronic respiratory failure, Medically complex children defined as children who have a long-term dependence on technological support (including tracheotomy) associated with developmental delay and/or genetic anomalies21, Obesity, Infant, i.e. child ≤1 year old. Confirmed SARS-CoV-2 infection OR high-risk exposure as defined: Confirmed infection: Child who tested positive for COVID-19 and is no more than 168 hours after onset of symptoms (and within 192 hours at the time of receipt of plasma). High-risk exposure: Susceptible child who was not previously infected or otherwise immune to SARS-CoV-2 and exposed within 96 hours prior to enrollment (and within 120 hours at the time of receipt of plasma). Both criteria below should be met: A household member or daycare center (same room) exposure to a person with [confirmed SARS-CoV-2 OR with clinically compatible disease in regions with widespread ongoing transmission] and a negative for SARS-CoV-2 (nasopharyngeal swab) Subject is judged by the investigator to have the initiative and means to be compliant with the protocol. Subjects or their legal representatives must have the ability to read, understand, and provide written informed consent for the initiation of any study related procedures. Exclusion Criteria: History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Subjects with minor reactions such as fever, itching, chills, etc. that resolve spontaneously or respond to pre-medications, and that do not represent more significant allergic reactions will not be excluded. Inability to complete therapy with the study product within the stipulated time frame outlined above Female subjects in child-bearing age with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. Subject / caregiver deemed by the study team to be non-compliant with the study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay K Jain, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospitals

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34855624

Citation

Gordon O, Brosnan MK, Yoon S, Jung D, Littlefield K, Ganesan A, Caputo CA, Li M, Morgenlander WR, Henson SN, Ordonez AA, De Jesus P, Tucker EW, Peart Akindele N, Ma Z, Wilson J, Ruiz-Bedoya CA, Younger MEM, Bloch EM, Shoham S, Sullivan D, Tobian AA, Cooke KR, Larman B, Gobburu JV, Casadevall A, Pekosz A, Lederman HM, Klein SL, Jain SK. Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children. JCI Insight. 2022 Jan 25;7(2):e151518. doi: 10.1172/jci.insight.151518.

Results Reference

derived

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Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)

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