Seroepidemiological Survey on the Impact of Smoking on SARS-CoV-2 Infection and COVID-19 Outcomes: Protocol for the Troina Study
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Abstract
After the global spread of SARS-CoV-2, research has highlighted several aspects of the pandemic, focusing on clinical features and risk factors associated with infection and disease severity. However, emerging results on the role of smoking in SARS-CoV-2 infection susceptibility or COVID-19 outcomes are conflicting, and their robustness remains uncertain.
Objective
In this context, this study aims at quantifying the proportion of SARS-CoV-2 antibody seroprevalence, studying the changes in antibody levels over time, and analyzing the association between the biochemically verified smoking status and SARS-CoV-2 infection.
Methods
The research design involves a 6-month prospective cohort study with a serial sampling of the same individuals. Each participant will be surveyed about their demographics and COVID-19–related information, and blood sampling will be collected upon recruitment and at specified follow-up time points (ie, after 8 and 24 weeks). Blood samples will be screened for the presence of SARS-CoV-2–specific antibodies and serum cotinine, being the latter of the principal metabolite of nicotine, which will be used to assess participants’ smoking status.
Results
The study is ongoing. It aims to find a higher antibody prevalence in individuals at high risk for viral exposure (ie, health care personnel) and to refine current estimates on the association between smoking status and SARS-CoV-2/COVID-19.
Conclusions
The added value of this research is that the current smoking status of the population to be studied will be biochemically verified to avoid the bias associated with self-reported smoking status. As such, the results from this survey may provide an actionable metric to study the role of smoking in SARS-CoV-2 infection and COVID-19 outcomes, and therefore to implement the most appropriate public health measures to control the pandemic. Results may also serve as a reference for future clinical research, and the methodology could be exploited in public health sectors and policies.
International Registered Report Identifier (IRRID)
DERR1-10.2196/32285
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SciScore for 10.1101/2021.04.29.21256236: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Exclusion criteria will be refusal to provide informed consent, or contraindication to venipuncture.
Field Sample Permit: Local field work staff will be trained for each relevant data collection process and logistic related procedure.Sex as a biological variable not detected. Randomization The study population will consist of a population-based, age-stratified cohort in Troina that will be sampled through random selection of town residents. Blinding not detected. Power Analysis not detected. Cell Line Authentication Authentication: Serological testing: Serologic assays of high sensitivity and specificity for SARS-CoV-2 have been recently validated and published. Table 2: Resources
Antibodies Se… SciScore for 10.1101/2021.04.29.21256236: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Exclusion criteria will be refusal to provide informed consent, or contraindication to venipuncture.
Field Sample Permit: Local field work staff will be trained for each relevant data collection process and logistic related procedure.Sex as a biological variable not detected. Randomization The study population will consist of a population-based, age-stratified cohort in Troina that will be sampled through random selection of town residents. Blinding not detected. Power Analysis not detected. Cell Line Authentication Authentication: Serological testing: Serologic assays of high sensitivity and specificity for SARS-CoV-2 have been recently validated and published. Table 2: Resources
Antibodies Sentences Resources Serum samples will be screened for the presence of SARS-CoV-2 specific antibodies using a quantitative enzyme linked immunosorbent assay (ELISA) test for anti-SARS-CoV-2 IgG (Euroimmun, CND anti-SARS-CoV-2 IgGsuggested: NoneAntigen-specific antibodies will be detected using peroxidase-labeled rabbit anti– human IgG (Dako, https://www.agilent.com) and TMB as a substrate. Antigen-specificsuggested: NoneSoftware and Algorithms Sentences Resources Antigen-specific antibodies will be detected using peroxidase-labeled rabbit anti– human IgG (Dako, https://www.agilent.com) and TMB as a substrate. https://www.agilent.comsuggested: (Agilent Technologies, RRID:SCR_013575)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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.
Results from scite Reference Check: We found no unreliable references.
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