NCT05967052

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome
• COVID-19, Long Haul

Interventions

Type	Name	Description
DRUG	Pregabalin	Pregabalin pharmacotherapy
BEHAVIORAL	Independent walking training	Independent walking training
DRUG	Placebo	Placebo
BEHAVIORAL	Gradual movement therapy in the ward	Gradual movement therapy in the ward
BEHAVIORAL	Telerehabilitation	Telerehabilitation
BEHAVIORAL	Psychotherapy	Psychotherapy

Timeline

• Start date: 2023-10-24
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-08-01
• Last updated: 2023-11-14

Locations

1 site across 1 country: Poland