This is a single-center, prospective, randomized, double-blind (pharmacotherapy),placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determinethe 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 twodivided doses), comprehensive rehabilitation with a placebo drug, comprehensiverehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divideddoses) 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 studyschedule.It is planned to include 132 patients in the study, which, assuming a 10% level ofnon-completion of the program, will result in the examination of 120 patients (30 in eacharm).Patients will be recruited during an outpatient medical consultation with a generalpractitioner or neurologist, psychiatrist, psychologist or other specialists, as well aswith the use of information materials in the form of leaflets and advertisements on theInternet.
Not Provided
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
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.
Centrum Wsparcia Badań Klinicznych
Warsaw, Mazowieckie, Poland
Investigator: Agnieszka Kurowska
Contact: 691 326 114
agnieszka.kurowska@spartanska.pl
Beata Tarnacka, Prof, Md, PhD
22 6709176 - +48
klinika.rehabilitacji@spartanska.pl
Beata Tarnacka, Prof, Md, PhD, Principal Investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation