Clinical trial NCT05967052: Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Official title: Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Fatigue Syndrome
COVID-19, Long Haul
Keywords: chronic fatigue syndrome
associated with post-COVID syndrome
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
Collaborators: name: Medical Research Agency, Poland
First posted: 2023-08-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the 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 two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) 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 study schedule.

It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm).

Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.


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.

Primary outcomes:
measure: Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
timeFrame: 3 months and 6 months
measure: Walking distance as a difference in score from the 6 Minute Walking Test
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)
timeFrame: 3 months and 6 months
measure: Change in the result obtained in the "Beck Depression Inventory (BDIII)" study
timeFrame: 3 months and 6 months
measure: Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)
timeFrame: 3 months and 6 months
measure: Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i
timeFrame: 3 months and 6 months
measure: Change in the result of the CCT test
timeFrame: 3 months and 6 months
measure: Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)
timeFrame: 3 months and 6 months
measure: Change in the result of the RFFT test
timeFrame: 3 months and 6 months
measure: Change in the WAIS-R intelligence test result
timeFrame: 3 months and 6 months
measure: Change in reaction time expressed by the Stroop interference test
timeFrame: 3 months and 6 months
measure: Change in the assessment of the quality of gait
timeFrame: 3 months and 6 months
measure: Change in walking speed
timeFrame: 3 months and 6 months
Other outcomes:
measure: The change in the profile of the examined inflammatory cytokines
timeFrame: 3 months and 6 months
measure: Number of adverse events and the number and percentage of patients who experienced adverse events
timeFrame: 3 months and 6 months
measure: Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
timeFrame: 3 months and 6 months
measure: Number of serious adverse events and number and proportion of patients with serious adverse events.
timeFrame: 3 months and 6 months
measure: Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
timeFrame: 3 months and 6 months
measure: Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.
timeFrame: 3 months and 6 months
Locations:
city: Warsaw
country: Poland
facility: Centrum Wsparcia Badań Klinicznych
state: Mazowieckie
Study officials:
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Beata Tarnacka, Prof, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: