Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
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|ClinicalTrials.gov Identifier: NCT04462848|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection||Biological: anti-SARS-CoV-2 human convalescent plasma||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: anti-SARS-CoV-2 human convalescent plasma
single transfusion of human convalescent plasma
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.
- Cumulative incidence of Grade 3 and Grade 4 adverse events [ Time Frame: up to Day 28 post-administration of study plasma ]
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.
- Cumulative incidence of serious adverse events [ Time Frame: up to Day 28 post-administration of study plasma ]
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.
- Proportion of participants with disease worsening event. [ Time Frame: up to Day 28 post-administration of study plasma ]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.
- Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies [ Time Frame: Days 0, 7, 14, and 28 ]Anti-SARS-CoV-2 antibody titer changes over time
- Percentage of participants with a natural antibody response to SARS-CoV-2 infection [ Time Frame: once between Day 60 and Day 120 ]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
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): NCT04462848
|Contact: Jaime G Deville, M.D.||email@example.com|
|Principal Investigator:||Jaime G Deville, M.D.||UCLA Clinical Professor of Pediatrics|