Very little is known about possible clinical sequelae that may persist after resolution of the acute 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. ISARIC Global COVID-19 follow-up working group has in collaboration with a range of experts developed a protocol and a patient survey to assess long term health and psychosocial consequences of COVID-19.
Sites are welcome to download the open access patient data collection forms, protocol and consent form for independent study and contribute to combined analysis to forward knowledge into COVID-19.
The form is developed to allow patient self-assessment online, or via post, or for telephone or in-clinic assessment.
The data can be entered onto REDCap and linked to acute phase clinical data.
For patients not already recorded into REDCap we advice to complete the Core- or RAPID COVID-19 CRF retrospectively.
The data can be complemented with sampling for further analysis.
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 subsets of patients experiencing specific symptomatology or syndromes for further follow up. A Tier 2 module will be developed for further 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 sequelae, 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.
ISARIC Global COVID-19 follow up working group:
Louise Sigfrid, John Amuasi, Fernando bozza, Ibrahim Richard Bangura, Anders Benjamin Kildal, Jan Cato Holter, Antonia Ho, Lance Turtle, Clark Russell, Jordi Rello, Daniel Munblit, Anne Margarita Dyrholt-Riise, Carlo Palmieri, Edwin Jesudason, Wei Shen Lim, Muge Cevik, Tom Drake, Katrina Hann, Anna Beltrame, Madiha Hashmi, Sulaiman Lakoh, Jo McPeake, Colin Berry, David Lowe, Natalie Elkheir, Janet Scott.