ISARIC COVID-19 Longitudinal Follow Up study
Creators: name: Sigfrid, Louise
name: Cevik, Muge
name: Fowler, Robert
name: Amuasi, John
name: bozza, Fernando
name: Bangura, Ibrahim
name: Kildal, Anders Benjamin
name: Holter, Jan
name: Ho, Antonia
name: Turtle, Lance
name: Russell, Clark
name: Rello, Jordi
name: Munblit, Daniel
name: Dyrhol-Riise, Anne
name: Palmieri, Carlo
name: Jesudason, Edwin
name: Lim, Wei
name: Drake, Tom
name: Hann, Katrina
name: Beltrame, Anna
name: Hashmi, Madiha
name: Lakoh, Sulaiman
name: Donohue, Chloe
name: Hardwick, Hayley
name: Elkheir, Natalie
name: Carson, Gail
name: Semple, Malcom
name: Scott, Janet
Publisher: name: Open Science Framework
Year: 2022
Subjects: subject: Medicine and Health Sciences
subject: #COVID-19LongTermConsequences
subject: #COVID-19 #SARS-CoV-2 #Coronavirus #FollowUp #ClinicalResearch #CCP #Pandemic #Research #OutsmartEpidemics
subject: #LongCovid

description: The International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) observational study of longer term physical and psychosocial consequences of COVID-19. Background: 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 prospective, observational multi-site study. It will enrol patients following a diagnosis of COVID-19. Tier 1 is developed to be used 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 and psychosocial consequences in patients post-COVID-19. Secondary aim include 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 and cell-mediated immune responses to SARS-CoV-2. Dissemination This 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, which will 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.Data from combined analysis will be disseminated through the ISARIC website and in open-access publications, under a group authorship. Open invitation to join this global, collaborative study: We welcome sites who treat patients with COVID-19 to join this global effort, contributing acute and/or follow up data. The protocol and associated standardised case report forms are available as open access downloads on the ISARIC website (https://isaric.tghn.org/covid-19-clinical-research-resources/). Sites can enter data using the downloadable paper forms or request access to the free, open access electronic forms (REDCap) by contacting ncov@isaric.org. Sites retain ownership of their data for independent studies and/or to contribute to the collaborative, combined analysis.