SIREN protocol: Impact of detectable anti-SARS-CoV-2 on the subsequent incidence of COVID-19 in 100,000 healthcare workers: do antibody positive healthcare workers have less reinfection than antibody negative healthcare workers?
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Abstract
Background
The overall risk of reinfection in individuals who have previously had COVID-19 is unknown. To determine if prior SARS-CoV-2 infection (as determined by at least one positive commercial antibody test performed in a laboratory) in healthcare workers confers future immunity to reinfection, we are undertaking a large-scale prospective longitudinal cohort study of healthcare staff across the United Kingdom.
Methods
Population and Setting: staff members of healthcare organisations working in hospitals in the UK
At recruitment, participants will have their serum tested for anti-SARS-CoV-2 at baseline and using these results will be initially allocated to either antibody positive or antibody negative cohorts. Participants will undergo antibody and viral RNA testing at 1-4 weekly intervals throughout the study period, and based on these results may move between cohorts. Any results from testing undertaken for other reasons (e.g. symptoms, contact tracing etc.) or prior to study entry will also be included. Individuals will complete enrolment and fortnightly questionnaires on exposures and symptoms. Follow-up will be for at least 12 months from study entry.
Outcome
The primary outcome of interest is a reinfection with SARS -CoV-2 during the study period. Secondary outcomes will include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres.
Conclusion
This large study will help us to understand the impact of the presence of antibodies on the risk of reinfection with SARS-CoV-2; the results will have substantial implications in terms of national and international policy, as well as for risk management of contacts of COVID-19 cases.
Trial Registration
IRAS ID 284460, HRA and Health and Care Research Wales approval granted 22 May 2020.
Article activity feed
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SciScore for 10.1101/2020.12.15.20247981: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Weaknesses: Cohort retention will be an important consideration for the study team, to avoid losing power to detect the primary outcome and potential introduction of bias if there is differential attrition by cohort. To mitigate this, the study team will actively monitor withdrawals and participant feedback, to implement improvements and …
SciScore for 10.1101/2020.12.15.20247981: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Weaknesses: Cohort retention will be an important consideration for the study team, to avoid losing power to detect the primary outcome and potential introduction of bias if there is differential attrition by cohort. To mitigate this, the study team will actively monitor withdrawals and participant feedback, to implement improvements and will establish direct participant communications (e.g. a newsletter) to promote engagement. Over the study period, it is likely that vaccine trials and usage will increase; adjustments to the study methodology may be required to permit co-enrolment and retain SIREN participants who subsequently receive vaccines, and to incorporate vaccine efficacy into the analyses. Differences in demographics, general health and ongoing risk of exposure between healthcare workers and the general population mean that the results may not be fully generalisable to the UK population.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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