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Cochrane COVID-19 Studienregister
Studienbericht
ACTRN12621001519842Erstmals veröffentlicht: 2022 Jan 28Letzte Aktualisierung: 2022 Jan 28

The Herekorenga - Freedom Study - Understanding COVID-19 antibody levels to help open up Aotearoa New Zealand

  1. Studientyp
  2. Interventional
  1. Studienziel
  2. Diagnostic/Prognostic
  1. Studiendesign
  2. Other
  1. Interventionszuordnung
  2. Non-randomised
Referenzdatensätze

The Herekorenga - Freedom Study - Understanding COVID-19 antibody levels to help open up Aotearoa New Zealand

ACTRN12621001519842
Eintrag in Studienregister
Keine Ergebnisse
INTERVENTION: Participants will be required to attend the designated Tend Medical Clinic (in Auckland) at a pre-arranged time, where all documentation such as the questionnaire and PISCF will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study. This will be the only time a sample from participants will be taken for this study. It is estimated participants will require 20 - 30 minutes to complete documentation and sample collection. These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis of the samples on the PictArray™ SARS-CoV-2 IgG Enzyme linked immunosorbent assay (ELISA) . This allows the analysis to be conducted under blinded study conditions. Pictor will then receive the data from the samples for further statistical analysis. A report detailing the presence or absence of antibodies towards the COVID-19 virus spike and nucleocapsid proteins will be compiled using this analysis. CONDITION: COVID-19 ; ; COVID-19 Infection - Other infectious diseases PRIMARY OUTCOME: This clinical trial would assess the Spike protein (SP) and Nucleocapsid protein (NP) ratio in serum found in different populations : naive, previously infected individuals and vaccinated individuals by PictArray™ SARS-CoV-2 IgG ELISA.[Once only - on the day of enrolment at the Tend Medical Clinic] SECONDARY OUTCOME: The development of a risk score based on the results of the PictArray™ SARS-CoV-2 IgG ELISA SP and NP ratio's. [Once only - on the day of enrolment at the Tend Medical Clinic] INCLUSION CRITERIA: Participation by people of all genders, ages and ethnicities is encouraged in this study. Pictor would like to get a representative selection of Aotearoa New Zealand’s unique population. We are especially encouraging people who fall into the following categories to become involved in this study. I. People who have been infected with COVID-19 II. People who have been vaccinated (one (1) or two (2) doses) III. People who have not been infected with COVID-19 and have not been vaccinated SCIENTIFIC TITLE: Using the PictArray™ SARS-CoV-2 IgG ELISA Test to better understand COVID-19 antibody levels within the Aotearoa New Zealand population