Actively Recruiting
Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2023-11-14
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pregabalin and comprehensive rehabilitation as treatments for chronic fatigue syndrome following COVID-19 infection in this phase II clinical trial. The study is designed as a single-center, prospective, randomized, double-blind, placebo-controlled trial to assess pregabalin's potential benefits in this new indication, involving patients who have had COVID-19 at least six months prior and meet specific fatigue syndrome criteria. Participants are randomly assigned in equal groups to receive either pregabalin (75-300 mg daily in two doses), comprehensive rehabilitation with a placebo, comprehensive rehabilitation combined with pregabalin, or placebo alone for six months. Rehabilitation includes independent walking training, gradual movement therapy, telerehabilitation, and psychotherapy. The treatment period lasts about 177 to 187 days. Participants will attend four outpatient visits at the research center and have 12 telephone consultations throughout the study. Researchers will assess changes in fatigue intensity using the Multidimensional Fatigue Inventory-20, walking distance with the 6 Minute Walking Test, and various secondary outcomes including life satisfaction, depression, anxiety, disease acceptance, cognitive tests, gait quality, and walking speed. Safety and progress are monitored regularly during the trial, which plans to enroll 132 patients aged 18 to 65 years.
CONDITIONS
Brief Title
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent to participate in the study
- Men or women aged 18 to 65 years at the time of consent
- At least 6 months since confirmed SARS-CoV-2 infection, including asymptomatic cases
- Meets diagnostic criteria for chronic fatigue syndrome according to the National Academy of Medicine (2015)
- Women must be either unable to have children or use highly effective contraception with a negative pregnancy test
- Willing to participate in all study activities
- Able to understand study information and provide informed consent
You will not qualify if you...
- Disorders affecting vital functions
- Known allergy to pregabalin or its excipients such as lactose
- Moderate or severe depression during treatment or at baseline psychiatric evaluation
- Current treatment with opioids or other antiepileptic drugs including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive pharmacotherapy with pregabalin or placebo and/or behavioral rehabilitation interventions including independent walking training, gradual movement therapy, telerehabilitation, and psychotherapy to manage chronic fatigue syndrome after COVID.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
B
Beata Tarnacka, Prof, Md, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here