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

Launched by NATIONAL INSTITUTE OF GERIATRICS, RHEUMATOLOGY AND REHABILITATION, POLAND · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a medication called pregabalin is for treating Chronic Fatigue Syndrome (CFS) that some people experience after recovering from COVID-19. The study will compare the effects of pregabalin with a rehabilitation program and a placebo (a dummy treatment with no active ingredients) over a period of six months. Participants will be randomly assigned to one of four groups: one will receive pregabalin, another will get a placebo along with rehabilitation, a third group will receive both pregabalin and rehabilitation, and the last group will only receive a placebo. The trial involves four visits to the research center and 12 phone consultations.

To be eligible for this study, participants should be between 18 and 65 years old, have had a confirmed COVID-19 infection at least six months prior, and meet the criteria for Chronic Fatigue Syndrome. Women who can have children must use effective birth control. Participants will need to provide consent to join the study and be willing to follow all the required steps. This trial is currently recruiting participants, and a total of 132 people are expected to take part. If you or someone you know might be interested, talk to a healthcare provider for more information.

Gender

ALL

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.