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Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation — POSTCOVID  

Chronic Fatigue Syndrome Clinical Trial

Official title:
Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome

Clinical Trial Summary

This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome). Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). There will be 4 outpatient visits to the research center and 12 telephone consultations. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05967052
Study type Interventional
Source National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Contact Beata Tarnacka, Prof, Md, PhD
Phone 22 6709176
Email klinika.rehabilitacji@spartanska.pl
Status Recruiting
Phase Phase 2
Start date October 24, 2023
Completion date March 1, 2028
View Details
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