CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


VenepunctureWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1702 Oral fluid swab Wiki 1.00

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D008585 Meningitis, Meningococcal NIH 1.00
D008581 Meningitis, Mening NIH 1.00
D004165 Diphtheria NIH 1.00

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001287 Meningitis HPO 1.00

There is one clinical trial.

Clinical Trials


1 Serum Testing of Representative Youngsters: Sero- Epidemiological Survey of England in 2019/2020

This is a pilot study to assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0-24 years, focusing on assessing humoral immunity against diphtheria, Group C invasive meningococcus and SARS-CoV-2. The investigators will recruit 2800 to 3500 individuals, divided into two groups: Group one (N= 2300): This will include all age groups (0-24years), with recruitment restricted by postcodes provided by Public Health England (PHE) to recruit a representative population for the region as assessed by the IMD (Index of Multiple Deprivation scores). Group two (N= up to 1200): This group has been added following additional funding to enhance the sample size in response to the COVID-19 pandemic. This will recruit 0-19 year olds and will not be restricted by post code sampling. Instead recruitment will be by public promotion within the normal recruiting regions for each site.

NCT04061382 Serogroup C Meningococcal Meningitis Diphtheria COVID-19 Procedure: Venepuncture Procedure: Oral fluid swab
MeSH:Diphtheria Meningitis, Meningococcal Meningitis
HPO:Meningitis

Primary Outcomes

Description: Measure the representativeness of participants as compared to the census data for the study region.

Measure: Feasibility of developing an England based sero-epidemiological programme in 0-24 year olds

Time: 11months

Description: Test serological markers of immunity for vaccine preventable diseases starting with diphtheria.

Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

Time: 11 months

Description: Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C.

Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

Time: 11 months

Description: Test serological markers to determine the true number of infections with SARS-CoV-2 in the population.

Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

Time: 11 months

Secondary Outcomes

Description: Recruitment rate per month, recruitment rates as percentage of potential participants contacted

Measure: Recruitment rate

Time: 11 Months

Description: Cost per sample obtained of 'disease specific correlates of protection/markers of immunity, e.g. Anti-Diphtheria Toxoid IgG concentrations and Capsular Group C meningococcal Serum bactericidal activity (SBA) titres and Serum IgG to SARS-CoV-2 antigens, including spike protein (as measured by ELISA and/or neutralising assay)

Measure: Cost

Time: 12 months

Description: IgG to COVID-19 spike protein

Measure: To assess, in relevant age groups, antibody concentrations against infections and vaccine preventable diseases

Time: 11 months

Description: A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history. Serum IgG to SARS-CoV-2 antigens, including spike protein (as measured by ELISA and/or neutralising assay)

Measure: Sera collection

Time: 11 months

Description: • Representativeness of participants sampled, in terms of the local population's ethnicity, community identity, migrant population and socioeconomic background in group 1 and group 2. Differences in immunological read outs PCR for SARS-CoV-2 on saliva samples this will be stored and processed at the end of the study. IgA to SARS-CoV-2 in saliva paired with serum samples.

Measure: Exploratory

Time: 11 months

Description: • T cell responses to SARS-CoV-2 antigens including, but not limited to S, M and N proteins, as measured by techniques including, but not limited to ELISpot ICS Proliferation assay

Measure: Exploratory

Time: 6 months

Description: • Antigen specific IgG and T cells against non-SARS-CoV-2 coronaviruses (e.g. NL62 and 229E)

Measure: Exploratory

Time: 6 months


Related HPO nodes (Using clinical trials)