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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04377672
• Other study ID #: IRB00247557
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 13, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospitals	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events	Number of subjects with grade 3 and 4 adverse events during the study period.	28 days
Secondary	Number of Subjects With Disease Worsening Event	Disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death.	28 days
Secondary	Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers	Anti-SARS-CoV-2 antibody titer changes. Recipient titers 30 minutes after plasma.	30 minutes
Secondary	Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time	Half lives based on totality of data	at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.
Secondary	Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection	Presence or absence of endogenous anti-SARS-CoV-2 antibody titers.	up to 2 months