Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Pregabalin
干预措施: Independent walking training (Behavioral)
Pregabalin
干预措施: Pregabalin (Drug)
Pregabalin + Rehabilitation
干预措施: Gradual movement therapy in the ward (Behavioral)
Pregabalin + Rehabilitation
干预措施: Psychotherapy (Behavioral)
Pregabalin + Rehabilitation
干预措施: Independent walking training (Behavioral)
Pregabalin + Rehabilitation
干预措施: Telerehabilitation (Behavioral)
Rehabilitation + Placebo
干预措施: Independent walking training (Behavioral)
Rehabilitation + Placebo
干预措施: Placebo (Drug)
Rehabilitation + Placebo
干预措施: Gradual movement therapy in the ward (Behavioral)
Rehabilitation + Placebo
干预措施: Telerehabilitation (Behavioral)
Rehabilitation + Placebo
干预措施: Psychotherapy (Behavioral)
Placebo
干预措施: Independent walking training (Behavioral)
Pregabalin + Rehabilitation
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
时间窗: 3 months and 6 months
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score
Walking distance as a difference in score from the 6 Minute Walking Test
时间窗: 3 months and 6 months
Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline
次要结局
- Change in the WAIS-R intelligence test result(3 months and 6 months)
- Change in the result obtained in the "Beck Depression Inventory (BDIII)" study(3 months and 6 months)
- Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)(3 months and 6 months)
- Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i(3 months and 6 months)
- Change in the result of the CCT test(3 months and 6 months)
- Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)(3 months and 6 months)
- Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)(3 months and 6 months)
- Change in the result of the RFFT test(3 months and 6 months)
- Change in reaction time expressed by the Stroop interference test(3 months and 6 months)
- Change in the assessment of the quality of gait(3 months and 6 months)
- Change in walking speed(3 months and 6 months)