Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04377672|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2020
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection||Biological: Anti-SARS-CoV-2 Human Convalescent Plasma||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2|
|Actual Study Start Date :||May 28, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: Anti- SARS-CoV-2 Plasma
Human Convalescent Plasma
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.
- Safety of treatment with high-titer anti-SARS-CoV-2 plasma as assessed by adverse events [ Time Frame: 28 days ]Proportion of subjects with grade 3 and 4 adverse events during the study period
- Proportion of subjects with disease worsening event [ Time Frame: 28 days ]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 [ Time Frame: Up to 28 days ]Anti-SARS-CoV-2 antibody titer changes
- Proportion of subjects with a natural antibody response to SARS-CoV-2 infection [ Time Frame: 60-120 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377672
|United States, Maryland|
|Johns Hopkins Hospitals|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Sanjay K Jain, MD||Johns Hopkins University|