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.

Abstract:

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.