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

NCT ID: NCT04377672

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-12-13

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.

Conditions

SARS-CoV-2 Infection

Study Design

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

Study Groups

Anti- SARS-CoV-2 Plasma

Human Convalescent Plasma

Group Type: EXPERIMENTAL

Anti-SARS-CoV-2 Human Convalescent Plasma

Intervention Type: BIOLOGICAL

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.

Interventions

Anti-SARS-CoV-2 Human Convalescent Plasma

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.

Intervention Type: BIOLOGICAL

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:

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospitals

Baltimore, Maryland, United States

Countries

United States

References

Jacquot C, Gordon O, Noland D, Donowitz JR, Levy E, Jain S, Willis Z, Rimland C, Loi M, Arrieta A, Annen K, Drapeau N, Osborne S, Ardura MI, Arora S, Zivick E, Delaney M. Multi-institutional experience with COVID-19 convalescent plasma in children. Transfusion. 2023 May;63(5):918-924. doi: 10.1111/trf.17318. Epub 2023 Mar 30.

Reference Type: DERIVED

PMID: 36965173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34855624 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00247557

Identifier Type: -

Identifier Source: org_study_id