What is the recovery rate and risk of long-term consequences following a diagnosis of COVID-19? - A harmonised, global longitudinal observational study

Sigfrid, Louise; Cevik, Muge; Jesudason, Edwin; Lim, Wei Shen; Rello, Jordi; Amuasi, John Humphrey; Bozza, Fernando; Palmieri, Carlo; Munblit, Daniel; Holter, Jan Cato; Kildal, Anders Benjamin; Russell, Clark D; Ho, Antonia; Turtle, Lance; Drake, Thomas M; Beltrame, Anna; Hann, Katrina; Bangura, Ibrahim Richard; Fowler, Rob; Lakoh, Sulaiman; Berry, Colin; Lowe, David J; McPeake, Joanne; Hashmi, Madiha; Dyrhol-Riise, Anne Margarita; Donohue, Chloe; Plotkin, Daniel R; Hardwick, Hayley; Elkheir, Natalie; Lone, Nazir; Docherty, Annemarie B; Harrison, Ewen M; Baille, Kenneth J; Carson, Gail; Semple, Malcolm G; Scott, Janet T

Introduction Very little is known about possible clinical sequelae that may persist after resolution of the acute Coronavirus Disease 2019 (COVID-19). A recent longitudinal cohort from Italy including 143 patients recovered after hospitalisation with COVID-19 reported that 87% had at least one ongoing symptom at 60 day follow-up. Early indications suggest that patients with COVID-19 may need even more psychological support than typical ICU patients. The assessment of risk factors for longer term consequences requires a longitudinal study linked to data on pre-existing conditions and care received during the acute phase of illness. Methods and analysis This is an international open-access prospective, observational multi-site study. It will enrol patients following a diagnosis of COVID-19. Tier 1 is developed for following up patients day 28 post-discharge, additionally at 3 to 6 months intervals. This module can be used to identify sub-sets of patients experiencing specific symptomatology or syndromes for further follow up. A Tier 2 module will be developed for in-clinic, in-depth follow up. The primary aim is to characterise physical consequences in patients post-COVID-19. Secondary aim includes estimating the frequency of and risk factors for post-COVID- 19 medical sequalae, psychosocial consequences and post-COVID-19 mortality. A subset of patients will have sampling to characterize longer term antibody, innate and cell-mediated immune responses to SARS-CoV-2. Ethics and dissemination This collaborative, open-access study aims to characterize the frequency of and risk factors for long-term consequences and characterise the immune response over time in patients following a diagnosis of COVID-19 and facilitate standardized and longitudinal data collection globally. The outcomes of this study will inform strategies to prevent long term consequences; inform clinical management, direct rehabilitation, and inform public health management to reduce overall morbidity and improve outcomes of COVID-19.