What is the recovery rate and risk of long-term consequences following a diagnosis of COVID-19? A harmonised, global longitudinal observational study protocol
Authors: Sigfrid Louise , Cevik Muge , Jesudason Edwin , Lim Wei Shen , Rello Jordi , Amuasi John , Bozza Fernando , Palmieri Carlo , Munblit Daniel , Holter Jan Cato , Kildal Anders Benjamin , Reyes Luis Felipe , Russell Clark D , Ho Antonia , Turtle Lance , Drake Thomas M , Beltrame Anna , Hann Katrina , Bangura Ibrahim Richard , Fowler Robert , Lakoh Sulaiman , Berry Colin , Lowe David J , McPeake Joanne , Hashmi Madiha , Dyrhol-Riise Anne Margarita , Donohue Chloe , Plotkin Daniel , Hardwick Hayley , Elkheir Natalie , Lone Nazir I , Docherty Annemarie , Harrison Ewen , Baille J Kenneth , Carson Gail , Semple Malcolm G , Scott Janet T 
Published: March 2021

Introduction

Very little is known about possible clinical sequelae that may persist after resolution of acute COVID-19. A recent longitudinal cohort from Italy including 143 patients followed up 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 intensive care unit 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. The primary aim of this study is to characterise physical and psychosocial sequelae in patients post-COVID-19 hospital discharge.

Methods and analysis

This is an international open-access prospective, observational multisite study. This protocol is linked with the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) and the WHO’s Clinical Characterisation Protocol, which includes patients with suspected or confirmed COVID-19 during hospitalisation. This protocol will follow-up a subset of patients with confirmed COVID-19 using standardised surveys to measure longer term physical and psychosocial sequelae. The data will be linked with the acute phase data. Statistical analyses will be undertaken to characterise groups most likely to be affected by sequelae of COVID-19. The open-access follow-up survey can be used as a data collection tool by other follow-up studies, to facilitate data harmonisation and to identify subsets of patients for further in-depth follow-up. The outcomes of this study will inform strategies to prevent long-term consequences; inform clinical management, interventional studies, rehabilitation and public health management to reduce overall morbidity; and improve long-term outcomes of COVID-19.

Ethics and dissemination

The protocol and survey are open access to enable low-resourced sites to join the study to facilitate global standardised, longitudinal data collection. Ethical approval has been given by sites in Colombia, Ghana, Italy, Norway, Russia, the UK and South Africa. New sites are welcome to join this collaborative study at any time. Sites interested in adopting the protocol as it is or in an adapted version are responsible for ensuring that local sponsorship and ethical approvals in place as appropriate. The tools are available on the ISARIC website (www.isaric.org).

Protocol registration number

osf.io/c5rw3/

Protocol version

3 August 2020

EuroQol ID

37035.