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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Fatigue Syndrome; COVID-19, Long Haul
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin; Behavioral: Independent walking training; Behavioral: Gradual movement therapy in the ward; Behavioral: Telerehabilitation; Behavioral: Psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Beata Tarnacka, Prof, Md, PhD; Phone Number: +48 22 6709176; Email: klinika.rehabilitacji@spartanska.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-637
      • Recruiting
      • Centrum Wsparcia Badań Klinicznych
      • Contact: Agnieszka Kurowska; Phone Number: +48 691 326 114; Email: agnieszka.kurowska@spartanska.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo; Behavioral: Independent walking training; Independent walking training
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	Drug: Placebo; Placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)	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	3 months and 6 months
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
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
Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i	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	3 months and 6 months
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• Collaborators: Medical Research Agency, Poland
• Investigators: Principal Investigator: Beata Tarnacka, Prof, Md, PhD, National Institute of Geriatrics, Rheumatology and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: chronic fatigue syndrome; associated with post-COVID syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Syndrome; Fatigue; Fatigue Syndrome, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: NIGRIR_001POSTCOVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No