CovidResearchTrials by Shray Alag

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anti-SARS-CoV-2 human convalescent plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2973 quesionnair Wiki 1.00

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

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

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.

NCT04462848 Corona Virus Infection Biological: anti-SARS-CoV-2 human convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

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

Secondary Outcomes

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 time

Measure: 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 administration

Measure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection

Time: once between Day 60 and Day 120

No related HPO nodes (Using clinical trials)