search
Back to results

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

Primary Purpose

Chronic Fatigue Syndrome, COVID-19, Long Haul

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Pregabalin
Independent walking training
Placebo
Gradual movement therapy in the ward
Telerehabilitation
Psychotherapy
Sponsored by
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring chronic fatigue syndrome, associated with post-COVID syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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); 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. 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. Exclusion Criteria: 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.

Sites / Locations

  • Centrum Wsparcia Badań KlinicznychRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Pregabalin

Pregabalin + Rehabilitation

Rehabilitation + Placebo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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.
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.
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
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.
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.
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.
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
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.
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
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.

Full Information

First Posted
July 28, 2023
Last Updated
August 21, 2023
Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland
search

1. Study Identification

Unique Protocol Identification Number
NCT05967052
Brief Title
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
Acronym
POSTCOVID
Official Title
Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2028 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, COVID-19, Long Haul
Keywords
chronic fatigue syndrome, associated with post-COVID syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Title
Pregabalin + Rehabilitation
Arm Type
Experimental
Arm Title
Rehabilitation + Placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin pharmacotherapy
Intervention Type
Behavioral
Intervention Name(s)
Independent walking training
Intervention Description
Independent walking training
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Gradual movement therapy in the ward
Intervention Description
Gradual movement therapy in the ward
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation
Intervention Description
Telerehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Psychotherapy
Primary Outcome Measure Information:
Title
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
Description
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
Time Frame
3 months and 6 months
Title
Walking distance as a difference in score from the 6 Minute Walking Test
Description
Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)
Description
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
Time Frame
3 months and 6 months
Title
Change in the result obtained in the "Beck Depression Inventory (BDIII)" study
Description
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.
Time Frame
3 months and 6 months
Title
Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
3 months and 6 months
Title
Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i
Description
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
Time Frame
3 months and 6 months
Title
Change in the result of the CCT test
Description
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.
Time Frame
3 months and 6 months
Title
Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)
Description
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.
Time Frame
3 months and 6 months
Title
Change in the result of the RFFT test
Description
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.
Time Frame
3 months and 6 months
Title
Change in the WAIS-R intelligence test result
Description
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
Time Frame
3 months and 6 months
Title
Change in reaction time expressed by the Stroop interference test
Description
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.
Time Frame
3 months and 6 months
Title
Change in the assessment of the quality of gait
Description
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
Time Frame
3 months and 6 months
Title
Change in walking speed
Description
Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.
Time Frame
3 months and 6 months
Other Pre-specified Outcome Measures:
Title
The change in the profile of the examined inflammatory cytokines
Description
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.
Time Frame
3 months and 6 months
Title
Number of adverse events and the number and percentage of patients who experienced adverse events
Description
Number of adverse events and the number and percentage of patient who experienced adverse events
Time Frame
3 months and 6 months
Title
Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
Description
Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
Time Frame
3 months and 6 months
Title
Number of serious adverse events and number and proportion of patients with serious adverse events.
Description
Number of serious adverse events and number and proportion of patients with serious adverse events.
Time Frame
3 months and 6 months
Title
Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
Description
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
Title
Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata Tarnacka, Prof, Md, PhD
Phone
22 6709176
Ext
+48
Email
klinika.rehabilitacji@spartanska.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beata Tarnacka, Prof, Md, PhD
Organizational Affiliation
National Institute of Geriatrics, Rheumatology and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Wsparcia Badań Klinicznych
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Kurowska
Phone
691 326 114
Ext
+48
Email
agnieszka.kurowska@spartanska.pl

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs