COVID-19 Long term follow up study

As time passes, researchers and clinicians face the unknown; the health and wellbeing of patients who recovered from COVID-19.

ISARIC Global COVID-19 follow-up working group, in collaboration with the WHO and a range of experts, developed a study protocol and a patient survey for serial follow up of patients with confirmed COVID-19, to standardise data collection to facilitate timely, robust analysis to assess frequency and risk factors for long term health and psychosocial consequences of COVID-19.

Healthcare sites are welcome to download the open-access tools 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.

Global COVID-19 Long term follow up study timeline Infographic description During hospitalisation, the resources to be used are: The CORE Case Report Form (CRF), or a RAPID (CRF) or Medical Records to document the patient’s clinical characteristics of COVID-19, Risk factors, Clinical management, and Short-term outcomes. After discharge from the hospital (first three months), the initial follow-up survey (Tier 1 follow-up with or without research sampling) should be used to assess longer term physical & psychosocial complications. For additional follow up after the initial survey, the Tier 1 Ongoing Survey should be used (with or without sampling) at three to six months intervals for as long as required, depending on need and resources. The Tier 1 survey can be used to identify people with specific symptoms or complications to invite for more in-depth specialist data collection (Tier 2 (-/+ sampling) such as Respiratory, Chronic fatigue, Cardiology, Neurology

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First follow up time point: Use the Tier 1 Initial survey to capture data on physical and psychosocial health status at the completion time point and pre-Covid-19 baseline data.

Second and serial follow up time points: Use the Tier 1 Ongoing survey- same survey without the baseline data.

To register to use the electronic versions and online survey option contact:ncov@isaric.org

To join the ISARIC Global Follow up working group or for further information contact: louise.sigfrid@ndm.ox.ac.uk

The data will be linked to acute-phase data on risk factors and clinical care documented using the COVID-19 Core- or RAPID CRF.

For patients not already recorded into REDCap the Core- or RAPID COVID-19 CRF can be completed retrospectively.

The data can be complemented with sampling for virology, immunology, genomic and pathophysiology analysis

For existing COVID-19 Core or Rapid CRF users – the follow up form can be found at the end of the acute, Core and Rapid forms. For sites already following up patients using other forms, contact us to discuss options for merging the data already collected.

Summary

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 (-0/+2-3months), additionally depending on need and resources at 3 to 6 months intervals up to three to five years, depending on need and resources.  The Tier 1 modules can be used to identify subsets of patients experiencing specific symptomatology or syndromes for further follow up. A  Tier 2 modules will be developed for further in-clinic, in-depth follow up of a subset of patients experiencing persistent symptomatology.

ISARIC Global COVID-19 follow up working group

 Louise Sigfrid, John Amuasi, Fernando Bozza, Ibrahim Richard Bangura, Anders Benjamin Kildal, Jan Cato Holter, Luis Felipe Reyes Velasco, Jordi Rello, Daniel Munblit, Antonia Ho, Lance Turtle, Clark Russell,  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, Ellen Pauley, Annemarie Docherty, Ewen Harrison, Waasila Jassat, Murray Dryden, Malcom G Semple, Kenneth J Baille, Gail Carson, Janet Scott.