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Investigation of treating chronic fatigue syndrome after COVID with pharmacotherapy (pregabalin) or complex rehabilitation
EU CTIS ID: 2024-516174-30-01
What this study is testing
Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndrome
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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.
You likely can't join if
- 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;
See the full eligibility 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 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.
- 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.