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Clinical Trial Summary

Preliminary research from our group indicates that up to half of COVID-19 patients are experiencing symptoms consistent with severe fatigue a median of 10 weeks after their initial illness, while almost one third of those previously employed have not returned to work. At present, most clinical and research measurements of fatigue have relied upon self-reported perception of sensations such as exhaustion or weariness. Using such tools, there is an inherent challenge for clinicians in differentiating between patients who are experiencing fatigue at a psychosocial level, versus those who are actively physiologically and neurocognitively deconditioned. The TROPIC study will use our existing clinical expertise and technology assisted solutions to address features of post-COVID-19 fatigue by quantifying physiological signatures of adverse sequelae in adult patients previously diagnosed with COVID-19, who are now COVID-19 negative. Our suite of assessments will encompass four systems; physical deconditioning, orthostatic instability, neurocognitive deficits and respiratory sequelae. This will not only inform accurate objective diagnostics of post-COVID-19 Chronic Fatigue Syndrome, but will also guide clinicians in directing the most appropriate therapeutic interventions with maximum efficacy and specificity, bringing not only patient-related but also health system and economic benefits.


Clinical Trial Description

Background: At the time of writing, over 214 million people globally are infected with the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that up to 50% of people are experiencing debilitating levels of fatigue months after recovering from the acute phase of COVID-19, known as post COVID-19 Chronic Fatigue Syndrome (CFS). The most challenging aspect in the management of CFS for clinicians is the lack of objective measurement tools. At present, most clinical and research measurements of fatigue have relied upon self-reported perceptions of sensations such as exhaustion or weariness. We believe that an objective, technology-based assessment of this complex condition is required for the quantification of complex multi-system dynamic physiological signals in order to guide clinicians in directing targeted valuable resources towards therapeutic interventions with specificity and rigour to those patients who are most in need. Aim: The aim of the TROPIC study is to identify bio- signals and contributing factors in the development of post-Covid-19 Chronic Fatigue Syndrome using a suite of technology-assisted assessment techniques. TROPIC STUDY PARTICULARS: The primary endpoint will be successful recruitment and completion of data collection of 100 participants in the TROPIC cohort. Setting: Assessments will take place in the Falls and Syncope Unit and Clinical Research Facility of St James's Hospital. Participants: Participants will be recruited from five sources; (i) the Robert Mayne Day Hospital, (ii) the Falls and Syncope Unit, (iii) Participants from earlier post COVID-19 Fatigue research in SJH who have consented to be contacted for further studies, (iv) staff who contracted COVID-19, and (v) the Post COVID-19 outpatient (OPD) Clinic. Participants must be aged 18 years or older, have a history of COVID-19 and be free of exclusion criteria outlined in later sections. Data collection and analysis: Participants will be invited for one assessment session to St James's Hospital (SJH), where they will undergo a series of neurocardiovascular, neurocognitive and physical performance tests, outlined in more detail in later sections. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05027724
Study type Observational
Source University of Dublin, Trinity College
Contact Ann Monaghan, PhD
Phone +353863516483
Email [email protected]
Status Recruiting
Phase
Start date May 17, 2021
Completion date March 31, 2022

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