Protocol for rapid implementation of a SARS-CoV-2 sero-survey during the 2020 COVID-19 pandemic – who, where, how?
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Abstract
Introduction
The 2019 novel coronavirus disease (COVID-19) pandemic has had devastating consequences in the US, yet clinical research on its natural history and transmission outside hospitalized settings has faced tangible and intangible challenges due to uncertainty in testing, case ascertainment, and appropriate safety measures. To better understand temporal evolution of COVID-19 related serological and other immune responses during a pandemic, we designed and implemented a baseline cross-sectional study of asymptomatic community volunteers and first responders in metro-Atlanta before the predicted infection peak in 2020.
Methods
We recruited healthy community volunteers and first responders for health history, serology, and biobanking. Through an iterative process, we identified one location on our campus and one community location which were accessible, vacant, distant from COVID-19 testing sites, open for social distancing, private for informed consent, and operational for sanitation and ventilation. Research and cleaning supplies were obtained from other researchers and private online vendors due to shortages, and faculty directly participated in consenting and phlebotomy.
Results
A total of 369 participants completed the study visits over six full and three half days. Over half of Phase 1 (174/299, 58.2%) and Phase 2 (45/70, 64.3%) self-reported as healthcare workers, and there was a high percentage of participants reporting exposure to known COVID-19 cases (48.2% and 61.4%).
Conclusions
Rigorous prospective clinical research with informed consents and is possible during a pandemic. Effective recruitment for moderately large sample size is facilitated by direct faculty involvement, connections with the community, and non-financial support from colleagues and the institution.
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SciScore for 10.1101/2021.02.08.21251348: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. 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: 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 …
SciScore for 10.1101/2021.02.08.21251348: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. 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: 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.
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