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Clinical Trial Summary

Date of notification letter to the IRB informing start of recruitment activities: October 21, 2023. Long COVID is a multi-systemic condition comprising often severe and persistent symptoms (longer than 12 weeks) that follow a known episode of COVID-19 and cannot be explained by another medical condition. This condition is observed in up to 15% of all individuals after an acute episode of COVID-19, even in those who had a mild and oligosymptomatic SARS-CoV-2 infection. Around 40% of these patients present symptoms that significantly compromise their daily activities. There is increasing evidence that LONG COVID is accompanied by dysregulated, persistent and uncontrolled inflammation, often accompanied by the development of an autoreactive immune response, including autoantibodies. Symptoms can last months or years, particularly in cases of chronic fatigue syndrome, with significant proportions of individuals having significant chronic impairment, preventing the performance of work and social activities.

Clinical Trial Description

There is currently no approved therapies for Long COVID. Several clinical trials have been developed to address this clinical condition, however the results were based on small-scale pilot studies. We developed this adaptive, large-scale, prospective, double-blind clinical trial to evaluate the effect of chronic immune-inflammatory modulation on persistent Long-COVID symptoms. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06128967
Study type Interventional
Source Cardresearch
Contact Gilmar Reis, MD, PhD
Phone +553132416574
Status Recruiting
Phase Phase 3
Start date October 18, 2023
Completion date May 18, 2025

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