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

NCT04377672 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB00247557
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Keywords

convalescent; COVID-19; Coronavirus; plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Subjects With Disease Worsening Event

  28 days

• Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers

  30 minutes

• Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time

  at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.

• Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection

  up to 2 months

Study Arms (1)

Anti- SARS-CoV-2 Plasma

EXPERIMENTAL

Human Convalescent Plasma

Biological: Anti-SARS-CoV-2 Human Convalescent Plasma

Interventions

Anti-SARS-CoV-2 Human Convalescent Plasma 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.

Anti- SARS-CoV-2 Plasma

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospitals

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 36965173 DERIVED

• 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.

  PMID: 34855624 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The sample size of this cohort is small. Some participants in this study were immunocompromised, which could have altered their endogenous antibody responses. Single donor plasma was utilized rather than hyperimmune globulin due to practical issues of producing the product in the settings of a rapid response to a pandemic. Pharmacokinetic analysis for three participants was limited by the fact they received intravenous immunoglobulins as part of their routine care.

Results Point of Contact

• Title: Sanjay K. Jain
• Organization: Johns Hopkins University

sjain5@jhmi.ed

4105028241

Study Officials

• Sanjay K Jain, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: May 28, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 13, 2021
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)