Prospective cohort study of non-hospitalised COVID-19 patients: determining length of isolation and patient clinical development at home (COVID-HOME study)'

Guidelines on COVID-19 management are developed as we learn from this pandemic. Most research is on hospitalised patients but, the impact on non-hospitalised ones, their clinical evolution, infectiousness, spreading routes and isolation length is not well understood. Studies are scarce, have small sample sizes and contradictory results. A better understanding is needed to properly manage patients isolated at home and improve biosafety guidelines. RESEARCH QUESTIONS 1. To measure the duration and routes of viral shedding, genetic diversity, and development of immunity of non-hospitalised COVID-19 individuals to improve guidelines for biosafety and patient isolation 2. To establish guidelines for the management of COVID-19 patients at home, including early detection of clinical and laboratory predicting factors for severity HYPOTHESIS 1. We expect viral shedding to last longer than 14 days (and differ by specimen) but virus viability to be shorter. They will differ by age and depend on immunity. 2. We expect to predict mild versus more severe clinical evolution using clinical and (changes in) laboratory parameters APPROACH PLAN A prospective longitudinal study of non-hospitalised COVID-19 patients began on 19/03/2020. We expect to enrol 200 individuals during 9 months (including 4 months before funds granted). Consenting people are visited weekly at home to obtain clinical data, a blood sample for laboratory parameters; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion to test for SARS-CoV-2 by RT-PCR. Blood samples are tested for key parameters related to disease severity. Patients are followed on days 7, 14 and 21 after confirmed infection, and if still PCR positive, invited to continue weekly sampling until negative. Household members of infected individuals are invited to join the study. We hope to obtain funds for a further 7 months to perform further sampling, serology, viral genotyping, viral culture and data analysis.