Treating Chronic Fatigue Syndrome After COVID with Pregabalin or Rehabilitation

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

This study is testing whether the medication pregabalin or a rehabilitation program can help people with chronic fatigue syndrome after COVID feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (Research network)
• Locations: 1 site (Warsaw, Masovian Voivodeship)
• Trial ID: NCT05967052 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of pregabalin and comprehensive rehabilitation in treating chronic fatigue syndrome associated with post-COVID conditions. It is a single-center, randomized, double-blind, placebo-controlled study involving 132 patients who will be assigned to one of four treatment groups: pregabalin, rehabilitation with placebo, rehabilitation with pregabalin, or placebo alone. Participants will undergo treatment for six months, with regular outpatient visits and telephone consultations to monitor progress and outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with chronic fatigue syndrome at least six months after a confirmed COVID-19 infection.

Not a fit: Patients who do not meet the inclusion criteria, such as those with other underlying health conditions or those outside the specified age range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients suffering from chronic fatigue syndrome following COVID-19.

How similar studies have performed: Other studies have explored treatments for chronic fatigue syndrome, but the specific use of pregabalin for post-COVID fatigue is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. The patient correctly gave written informed consent to participate in the study;
2. Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent;
3. Patient after a minimum of 6 months from the documented detection of SARS-CoV-2 infection (document confirming the history of the disease, including a positive result of the PCR or antigen test, certificate of convalescence; medical documentation confirming the infection; the condition is also considered fulfilled in the case of documented infection asymptomatic);
4. During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to the National Academy of Medicine (2015);
5. Women:

   a) incapable of having children (post-menopausal or child-bearing, subjected to permanent sterilization); (b) of childbearing potential with a negative pregnancy test result at screening and using a highly effective method of contraception throughout the IMP use and for 7 days after the last IMP use.
6. The patient agrees to participate in all activities provided for in the study.
7. The patient is able to understand the information presented and give informed consent to participate in the study prior to screening.

Exclusion Criteria:

1. Vital functions disorders;
2. Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose);
3. Moderate or severe depression during treatment or present during psychiatric evaluation at baseline;
4. Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);
5. Pregnant or breastfeeding women.

Where this trial is running

Warsaw, Masovian Voivodeship

• Centrum Wsparcia Badań Klinicznych — Warsaw, Masovian Voivodeship, Poland (Recruiting)

Study contacts

• Principal investigator: Beata Tarnacka, Prof, Md, PhD — National Institute of Geriatrics, Rheumatology and Rehabilitation
• Study coordinator: Beata Tarnacka, Prof, Md, PhD

Conditions Chronic Fatigue Syndrome; COVID-19, Long Haul; chronic fatigue syndrome; associated with post-COVID syndrome