Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation

Chronic Fatigue Syndrome Clinical Trial

— POSTCOVID  

Official title:

Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967052
• Other study ID #: NIGRIR_001POSTCOVID
• Status: Recruiting
• Phase: Phase 2
• Start date: October 24, 2023
• Est. completion date: March 1, 2028

Study information

• Verified date: November 2023
• Source: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• Contact: Beata Tarnacka, Prof, Md, PhD
• Phone: 22 6709176
• Email: klinika.rehabilitacji[@]spartanska.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

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
• Telerehabilitation
Telerehabilitation
• Psychotherapy
Psychotherapy

Locations

Country	Name	City	State
Poland	Centrum Wsparcia Badan Klinicznych	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Medical Research Agency, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change in the profile of the examined inflammatory cytokines	The exploratory endpoint is the change in the profile of the examined inflammatory cytokines in the 3rd and 6th month of the study in relation to the result before the start of the study.	3 months and 6 months
Other	Number of adverse events and the number and percentage of patients who experienced adverse events	Number of adverse events and the number and percentage of patient who experienced adverse events	3 months and 6 months
Other	Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events	Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events	3 months and 6 months
Other	Number of serious adverse events and number and proportion of patients with serious adverse events.	Number of serious adverse events and number and proportion of patients with serious adverse events.	3 months and 6 months
Other	Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.	Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.	3 months and 6 months
Other	Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.	Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.	3 months and 6 months
Primary	Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score	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	3 months and 6 months
Primary	Walking distance as a difference in score from the 6 Minute Walking Test	Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline	3 months and 6 months
Secondary	Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczynski)	Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczynski) in the 3rd and 6th month of the study in relation to the result on the day of the study	3 months and 6 months
Secondary	Change in the result obtained in the "Beck Depression Inventory (BDIII)" study	Change in the result obtained in the "Beck Depression Inventory (BDIII)" study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.	3 months and 6 months
Secondary	Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)	Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.	3 months and 6 months
Secondary	Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczynski) i	Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczynski) in the 3rd and 6th month of the study in relation to the result on the day of starting the study	3 months and 6 months
Secondary	Change in the result of the CCT test	Change in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.	3 months and 6 months
Secondary	Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)	Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.	3 months and 6 months
Secondary	Change in the result of the RFFT test	Change in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.	3 months and 6 months
Secondary	Change in the WAIS-R intelligence test result	Change in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement	3 months and 6 months
Secondary	Change in reaction time expressed by the Stroop interference test	Change in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.	3 months and 6 months
Secondary	Change in the assessment of the quality of gait	Change in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study	3 months and 6 months
Secondary	Change in walking speed	Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.	3 months and 6 months