Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation (POSTCOVID)
Chronic Fatigue Syndrome, COVID-19, Long Haul
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring chronic fatigue syndrome, associated with post-COVID syndrome
Eligibility Criteria
Inclusion Criteria: The patient correctly gave written informed consent to participate in the study; Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent; 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); During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to the National Academy of Medicine (2015); 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. The patient agrees to participate in all activities provided for in the study. The patient is able to understand the information presented and give informed consent to participate in the study prior to screening. Exclusion Criteria: Vital functions disorders; Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose); Moderate or severe depression during treatment or present during psychiatric evaluation at baseline; Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine); Pregnant or breastfeeding women.
Sites / Locations
- Centrum Wsparcia Badań KlinicznychRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Pregabalin
Pregabalin + Rehabilitation
Rehabilitation + Placebo
Placebo