- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Charles Swanton
- Telefonnummer: 020 3796 0000
- E-post: crick-legacy@crick.ac.uk
Studiesteder
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London, Storbritannia
- Rekruttering
- UCLH
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Ta kontakt med:
- B Williams
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London, Storbritannia
- Rekruttering
- Ealing and Northwick Park hospital
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Ta kontakt med:
- S. Quaid
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Hovedetterforsker:
- P. Papineni
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London, Storbritannia
- Rekruttering
- The Francis Crick Institute
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Ta kontakt med:
- C Swanton
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
SARS-CoV-2 susceptibility in healthcare workers and patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UCLH 134617
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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