- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04750356
SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)
SARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity
The study aims to investigate SARS-CoV-2 susceptibility, transmission and disease severity in healthcare workers and patients.
Residual specimens from an existing collection of samples in viral inactivating buffer and derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1) and additional biological material collected prospectively (Cohorts A2 and B) will be used for research into SARS-CoV-2 transmission, evolution and immune control. This testing centre is a partnership between UCLH and The Francis Crick Institute to provide COVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitals and care homes. A third group (Cohort C) of the study will allow for collaborative work with other REC approved research studies that have used the Crick COVID-19 Consortium Testing centre and will involve the use of study samples already collected from each study to be analysed under the SARS-CoV-2 Longitudinal Study end points
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Charles Swanton
- Numero di telefono: 020 3796 0000
- Email: crick-legacy@crick.ac.uk
Luoghi di studio
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London, Regno Unito
- Reclutamento
- UCLH
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Contatto:
- B Williams
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London, Regno Unito
- Reclutamento
- Ealing and Northwick Park hospital
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Contatto:
- S. Quaid
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Investigatore principale:
- P. Papineni
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London, Regno Unito
- Reclutamento
- The Francis Crick Institute
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Contatto:
- C Swanton
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Individuals who have previously provided nasal throat swab samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre.
- ≥18 years of age
- To enrol in the SARS-CoV-2 positive cohort of the study, the participant should have a positive RT qPCR result
- Employees based at the participating sites including who had their serology and/or swab tested (for recruitment to Cohort B)
- Participants enrolled in other studies who had their samples processed by using the Crick COVID 19 Consortium Testing centre (for recruitment to Cohort C).
- Written informed consent (except Cohort A1)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Cohort A1
Healthcare workers and patients that have previously undertaken a swab or serology test to detect for the presence of SARS-CoV-2.
Without the need to seek retrospective consent for the SARS CoV 2 Longitudinal Study, residual samples and derivatives from the Crick COVID -9 Consortium Testing centre and data will be used for the study
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Cohort A2
3,000 SARS-CoV-2 positive and 3,000 SARS-CoV-2 negative participants (randomly selected) from cohort A1 will be prospectively consented to the study.
In addition, vaccine status will also be used to stratify the participants and recruit to the study.
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Cohort B
Employees at participating centres including but not limited to UCLH and The Francis Crick Institute who have their serology tested and/or are swabbed for viral (SARS-CoV-2 and seasonal viruses) detection as well as participants who are vaccinated will be prospectively consented to the study.
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Cohort C
Individuals recruited to other REC approved research studies where their samples are processed by the Crick COVID 19 Consortium Testing centre will also be consented in their existing study to allow the use of leftover study samples already collected and to be collected, for use in this longitudinal study.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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SARS-CoV-2 susceptibility in healthcare workers and patients
Lasso di tempo: 24 months
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To investigate SARS-CoV-2 susceptibility by examining the number of positive SARS-CoV-2 result per participant
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24 months
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SARS-CoV-2 transmission in healthcare workers and patients
Lasso di tempo: 24 months
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To investigate SARS-CoV-2 transmission by analysis of samples sequencing data from each study centre and across study centres
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24 months
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SARS-CoV-2 severity in healthcare workers and patients
Lasso di tempo: 24 months
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To investigate SARS-CoV-2 severity by review of symptom severity
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24 months
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SARS-CoV-2 severity in healthcare workers and patients
Lasso di tempo: 24 months
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To investigate SARS-CoV-2 severity by review of any hospital admissions
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24 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UCLH 134617
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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