Chronic Fatigue SyndromePhase 2POSTCOVIDNCT05967052

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

A Phase 2 study testing Pregabalin, Independent walking training and Gradual movement therapy in the ward in people with Chronic Fatigue Syndrome and COVID-19, Long Haul, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Fatigue Syndrome, COVID-19, Long Haul
What is being tested?: Pregabalin, Independent walking training and Gradual movement therapy in the ward
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 sitePoland
Study dates: 24 Oct 2023to 11 Sep 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, 02-637

Other trials in Poland

About this study

Official title: Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID 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.

Conditions: Chronic Fatigue Syndrome, COVID-19, Long Haul
Being tested: Pregabalin, Independent walking training, Placebo, Gradual movement therapy in the ward, Telerehabilitation
Keywords: chronic fatigue syndrome, associated with post-COVID syndrome
Medical subject headings: Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug
Pregabalin pharmacotherapy
Independent walking trainingBehavioural
Independent walking training
PlaceboDrug
Placebo
Gradual movement therapy in the wardBehavioural
Gradual movement therapy in the ward
TelerehabilitationBehavioural
Telerehabilitation
PsychotherapyBehavioural
Psychotherapy

Study groups in NCT05967052
Study group	Role	What they receive
Pregabalin	Experimental	Not described Receives: Drug: Pregabalin; Behavioral: Independent walking training
Pregabalin + Rehabilitation	Experimental	Not described Receives: Drug: Pregabalin; Behavioral: Independent walking training; Behavioral: Gradual movement therapy in the ward; Behavioral: Telerehabilitation; Behavioral: Psychotherapy
Rehabilitation + Placebo	Experimental	Not described Receives: Behavioral: Independent walking training; Drug: Placebo; Behavioral: Gradual movement therapy in the ward; Behavioral: Telerehabilitation; Behavioral: Psychotherapy
Placebo	Placebo comparator	Not described Receives: Behavioral: Independent walking training; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 3 months and 6 months

Secondary outcomes (11)

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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 202311 Sep 2025

First posted1 Aug 2023
Study start24 Oct 2023
Primary completion11 Sep 2025
Study completion11 Sep 2025

Why it stopped: occurrence of scientific risk

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05967052
Sponsor's protocol ID: NIGRIR_001POSTCOVID
Acronym: POSTCOVID
Status last verified: May 2025
First submitted: 28 Jul 2023
Last updated: 17 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
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Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis

All Chronic Fatigue Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
ClinicalTrials.gov ID: NCT05967052
Acronym / sponsor ID: POSTCOVID / NIGRIR_001POSTCOVID
Conditions: Chronic Fatigue Syndrome, COVID-19, Long Haul
Keywords: chronic fatigue syndrome, associated with post-COVID syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: occurrence of scientific risk
Enrolment: 23 participants (actual)
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
Collaborators: Medical Research Agency, Poland
Study start: 24 Oct 2023 (actual)
Primary completion: 11 Sep 2025 (actual)
Study completion: 11 Sep 2025 (actual)
First posted: 1 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Pregabalin	Experimental	Drug: Pregabalin, Behavioral: Independent walking training
Pregabalin + Rehabilitation	Experimental	Drug: Pregabalin, Behavioral: Independent walking training, Behavioral: Gradual movement therapy in the ward, Behavioral: Telerehabilitation, Behavioral: Psychotherapy
Rehabilitation + Placebo	Experimental	Behavioral: Independent walking training, Drug: Placebo, Behavioral: Gradual movement therapy in the ward, Behavioral: Telerehabilitation, Behavioral: Psychotherapy
Placebo	Placebo comparator	Behavioral: Independent walking training, Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PregabalinPregabalin pharmacotherapy	Drug	Pregabalin, Pregabalin + Rehabilitation
Independent walking trainingIndependent walking training	Behavioural	Placebo, Pregabalin, Pregabalin + Rehabilitation, Rehabilitation + Placebo
PlaceboPlacebo	Drug	Placebo, Rehabilitation + Placebo
Gradual movement therapy in the wardGradual movement therapy in the ward	Behavioural	Pregabalin + Rehabilitation, Rehabilitation + Placebo
TelerehabilitationTelerehabilitation	Behavioural	Pregabalin + Rehabilitation, Rehabilitation + Placebo
PsychotherapyPsychotherapy	Behavioural	Pregabalin + Rehabilitation, Rehabilitation + Placebo

Primary outcome

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
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

11 secondary outcomes

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 result obtained in the "Beck Depression Inventory (BDIII)" study
Time frame: 3 months and 6 months
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 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 result of the CCT test
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)
Time frame: 3 months and 6 months
Change in the result of the RFFT test
Time frame: 3 months and 6 months
Change in the WAIS-R intelligence test result
Time frame: 3 months and 6 months
Change in reaction time expressed by the Stroop interference test
Time frame: 3 months and 6 months
Change in the assessment of the quality of gait
Time frame: 3 months and 6 months
Change in walking speed
Time frame: 3 months and 6 months

Results and safety

The study was stopped early (reason given: occurrence of scientific risk). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.

Related trials for Chronic Fatigue Syndrome

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beata Tarnacka, Prof, Md, PhD principal investigator

National Institute of Geriatrics, Rheumatology and Rehabilitation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: occurrence of scientific risk). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score (time frame: 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05967052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.