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Research protocol design and implementation of a hybrid no-touch and low-touch prospective observational study during the COVID-19 public health emergency: the VISION study

bmjph · 2025-08-11 · canonical JSON source

7 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction The conduct of clinical research is essential during public health emergencies, including COVID-19, to characterise the natural history of the infection to inform case definitions, identify risk factors for severe disease, transmission patterns, short and long-term complications and safe and effective treatments and vaccines. Policies aimed at mitigating transmission of SARS-CoV-2 proved challenging to conduct clinical research. Here, we describe the Vital Status and Outcomes of COVID-19 (VISION) study, a hybrid no-touch and low-touch clinical research protocol following participants recently infected with SARS-CoV-2.Methods and analysis In this prospective longitudinal no-touch and low-touch observational study of recent SARS-CoV-2 infection, participants are enrolled virtually into a no-touch online primary cohort, which collects clinical information using electronic surveys. Eligible participants are able to additionally enrol into low-touch cohorts that collect biospecimens to characterise viral and immune dynamics.Ethics and dissemination The VISION study is approved by the UNC Biomedical Institutional Review Board. Virtual enrolment coupled with hybrid no and low-touch data collection reduces barriers to participation in clinical research while allowing for an expansive investigation of the COVID-19 disease course.