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

• ClinicalTrials.gov Identifier: NCT05967052
• Recruitment Status: Recruiting
• First Posted: August 1, 2023
• Last Update Posted: November 14, 2023
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• Collaborator: Medical Research Agency, Poland
• Information provided by (Responsible Party): National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Fatigue Syndrome; COVID-19, Long Haul	Drug: Pregabalin; Behavioral: Independent walking training; Drug: Placebo; Behavioral: Gradual movement therapy in the ward; Behavioral: Telerehabilitation; Behavioral: Psychotherapy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
• Actual Study Start Date: October 24, 2023
• Estimated Primary Completion Date: March 1, 2028
• Estimated Study Completion Date: March 1, 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pregabalin	Drug: Pregabalin; Pregabalin pharmacotherapy; Behavioral: Independent walking training; Independent walking training
Experimental: Pregabalin + Rehabilitation	Drug: Pregabalin; Pregabalin pharmacotherapy; Behavioral: Independent walking training; Independent walking training; Behavioral: Gradual movement therapy in the ward; Gradual movement therapy in the ward; Behavioral: Telerehabilitation; Telerehabilitation; Behavioral: Psychotherapy; Psychotherapy
Experimental: Rehabilitation + Placebo	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
Placebo Comparator: Placebo	Behavioral: Independent walking training; Independent walking training; Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score [ Time Frame: 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
2. Walking distance as a difference in score from the 6 Minute Walking Test [ Time Frame: 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

Secondary Outcome Measures :

1. Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) [ Time Frame: 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) in the 3rd and 6th month of the study in relation to the result on the day of the study
2. Change in the result obtained in the "Beck Depression Inventory (BDIII)" study [ Time Frame: 3 months and 6 months ]
   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. Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) [ Time Frame: 3 months and 6 months ]
   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.
4. Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i [ Time Frame: 3 months and 6 months ]
   Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study
5. Change in the result of the CCT test [ Time Frame: 3 months and 6 months ]
   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.
6. Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) [ Time Frame: 3 months and 6 months ]
   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.
7. Change in the result of the RFFT test [ Time Frame: 3 months and 6 months ]
   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.
8. Change in the WAIS-R intelligence test result [ Time Frame: 3 months and 6 months ]
   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
9. Change in reaction time expressed by the Stroop interference test [ Time Frame: 3 months and 6 months ]
   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.
10. Change in the assessment of the quality of gait [ Time Frame: 3 months and 6 months ]
    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
11. Change in walking speed [ Time Frame: 3 months and 6 months ]
    Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.

Other Outcome Measures:

1. The change in the profile of the examined inflammatory cytokines [ Time Frame: 3 months and 6 months ]
   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.
2. Number of adverse events and the number and percentage of patients who experienced adverse events [ Time Frame: 3 months and 6 months ]
   Number of adverse events and the number and percentage of patient who experienced adverse events
3. Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events [ Time Frame: 3 months and 6 months ]
   Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
4. Number of serious adverse events and number and proportion of patients with serious adverse events. [ Time Frame: 3 months and 6 months ]
   Number of serious adverse events and number and proportion of patients with serious adverse events.
5. Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events. [ Time Frame: 3 months and 6 months ]
   Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
6. Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs. [ Time Frame: 3 months and 6 months ]
   Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Beata Tarnacka, Prof, Md, PhD; 22 6709176 ext +48; klinika.rehabilitacji@spartanska.pl

Locations

Poland

Centrum Wsparcia Badań Klinicznych; Recruiting

Warsaw, Mazowieckie, Poland, 02-637

Contact: Agnieszka Kurowska 691 326 114 ext +48 agnieszka.kurowska@spartanska.pl

Sponsors and Collaborators

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Medical Research Agency, Poland

Investigators

• Principal Investigator: Beata Tarnacka, Prof, Md, PhD; National Institute of Geriatrics, Rheumatology and Rehabilitation

More Information

• Responsible Party: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• ClinicalTrials.gov Identifier: NCT05967052
• Other Study ID Numbers: NIGRIR_001POSTCOVID
• First Posted: August 1, 2023
• Last Update Posted: November 14, 2023
• Last Verified: November 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland:

chronic fatigue syndrome; associated with post-COVID syndrome

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic; Syndrome; Fatigue; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs