Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04462848
• Other study ID #: IRB#20-001263
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2020
• Est. completion date: December 2024

Study information

• Verified date: July 2020
• Source: University of California, Los Angeles
• Contact: Jaime G Deville, M.D.
• Phone: 310-825-9660
• Email: jdeville[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• Age = 1 month and < 18 years 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, 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 96 hours after onset of symptoms (and within 120 hours at the time of receipt of study 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 study plasma). Both criteria below should be met:

1. A household member or daycare center (same room) exposure to a person with confirmed SARS-CoV-2 OR with clinically compatible disease in areas with widespread ongoing transmission

2. Negative for SARS-CoV-2 (nasopharyngeal or oropharyngeal swab)

• For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening.

• Parent or legal guardian able and willing to provide signed parent permission.

Exclusion Criteria:

• History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Individuals 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.

• For females, breastfeeding, or planning to become pregnant/breastfeed during the study period.

• Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate outside the greater Los Angeles area during the study.

• Any condition that would, in the opinion of the principal investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• anti-SARS-CoV-2 human convalescent plasma
Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.

Locations

Country	Name	City	State
United States	University of California, Los Angeles (UCLA)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of Grade 3 and Grade 4 adverse events	A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated.; A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.	up to Day 28 post-administration of study plasma
Primary	Cumulative incidence of serious adverse events	A serious adverse event is any untoward or unfavorable medical occurrence that: results in death,; is life-threatening,; requires inpatient hospitalization or prolongation of existing hospitalization,; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or; is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.	up to Day 28 post-administration of study plasma
Secondary	Proportion of participants with disease worsening event.	Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.	up to Day 28 post-administration of study plasma
Secondary	Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies	Anti-SARS-CoV-2 antibody titer changes over time	Days 0, 7, 14, and 28
Secondary	Percentage of participants 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 to be collected once between 60 and 120 days post study plasma administration	once between Day 60 and Day 120