|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
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.
Description: 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.Measure: Cumulative incidence of Grade 3 and Grade 4 adverse events Time: up to Day 28 post-administration of study plasma
Description: 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.Measure: Cumulative incidence of serious adverse events Time: up to Day 28 post-administration of study plasma
Description: 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.Measure: Proportion of participants with disease worsening event. Time: up to Day 28 post-administration of study plasma
Description: Anti-SARS-CoV-2 antibody titer changes over timeMeasure: Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies Time: Days 0, 7, 14, and 28
Description: 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 administrationMeasure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection Time: once between Day 60 and Day 120
Data processed on September 26, 2020.