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Study of Pregabalin Treatment and Rehabilitation for Chronic Fatigue in Post-COVID Syndrome Patients

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating chronic fatigue syndrome that develops after COVID-19 infection, also known as post-COVID syndrome. The study will evaluate the effectiveness of two different treatment approaches: medication with pregabalin tablets and complex rehabilitation. Pregabalin is a prescription medication that will be compared to a placebo during the research.

The purpose of this study is to determine how well pregabalin and complex rehabilitation help reduce fatigue symptoms in people who have experienced persistent tiredness for at least 6 months after having COVID-19. The study will measure changes in fatigue levels and physical abilities, including how far participants can walk.

During the study, participants will take either pregabalin tablets or placebo tablets. The maximum daily dose of pregabalin will be 300 mg. The study will last for 6 months, during which various aspects of participants' health will be monitored, including their energy levels, walking ability, quality of life, sleep patterns, and emotional well-being. Regular assessments will be conducted to track participants' progress throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your participation begins with an assessment to confirm chronic fatigue syndrome related to previous COVID-19 infection
The medical team will verify that at least 6 months have passed since your documented SARS-CoV-2 infection
Female participants will undergo a pregnancy test and must confirm using effective contraception throughout the study
Step 2
Baseline measurements
You will complete several questionnaires about your fatigue levels, life satisfaction, and mental health
Physical tests will be conducted, including a 6-minute walking test to measure your walking distance
Various cognitive tests will be performed to assess your mental function
Blood samples will be collected to analyze inflammatory markers
Step 3
Treatment period start
You will receive either pregabalin tablets (75 mg) or placebo tablets for oral use
The medication or placebo must be taken as prescribed throughout the study period
Step 4
3-month assessment
After 3 months, you will undergo the same tests and questionnaires as at the beginning
Your walking ability, fatigue levels, and other symptoms will be reassessed
The medical team will check for any side effects or health changes
Step 5
6-month assessment
Final round of tests and questionnaires will be conducted
Physical and cognitive assessments will be repeated
Blood samples will be taken for final analysis
The medical team will perform a final safety evaluation

Who can join the trial?

7 criteria

Patient must provide written informed consent showing they understand and agree to participate in the study
Age requirement: Must be between 18 and 65 years old when signing the consent form
Must have documented evidence of previous SARS-CoV-2 infection (COVID-19) from at least 6 months ago, proven by either: - A positive PCR test result - A positive antigen test result - A recovery certificate - Medical records confirming infection - Documentation of asymptomatic infection
Must meet the criteria for chronic fatigue syndrome according to National Academy of Medicine (2015) standards during screening
For women participants: - Must either be unable to have children (post-menopausal or permanently sterilized), OR - If able to have children, must have a negative pregnancy test during screening and use effective contraception during the study and for 7 days after last treatment
Must agree to participate in all study activities
Must be capable of understanding provided information and giving informed consent before screening begins

Who cannot join the trial?

20 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of allergic reactions to pregabalin or similar medications
Severe kidney disease or impaired kidney function
Active liver disease or significantly elevated liver enzymes
Uncontrolled diabetes
History of substance abuse or addiction
Severe psychiatric disorders requiring medication
Current participation in other clinical trials
Unable to provide informed consent
Severe cardiovascular disease (heart problems)
History of seizures or epilepsy
Taking medications that may interact with pregabalin
Inability to complete the rehabilitation program
Severe respiratory problems that prevent exercise
Unstable medical conditions that could interfere with the study
Chronic pain conditions unrelated to post-COVID syndrome
Major surgery planned during the study period
Regular use of medications that affect fatigue symptoms
Inability to attend regular follow-up visits

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Investigated drugs

Pregabalin is a medication commonly used to treat nerve pain and anxiety disorders. In this trial, it is being studied for its potential to help patients who experience chronic fatigue after COVID-19 infection. It works by reducing abnormal electrical signals in the nervous system and may help improve energy levels and reduce fatigue symptoms. Complex rehabilitation is a comprehensive treatment approach that includes various physical exercises, therapeutic techniques, and lifestyle modifications. This therapy program is designed to help patients recover their strength, endurance, and daily functioning abilities after experiencing post-COVID syndrome. It typically involves supervised activities and exercises tailored to each patient's specific needs and capabilities.

Pregabalin

What is already known about the treatment

Pregabalin – An oral medication available in capsule form that belongs to the anticonvulsant class of drugs and acts as a nerve pain modulator. It works by binding to calcium channels in the nervous system, reducing the release of excitatory neurotransmitters and helping to calm overactive nerve signals. Pregabalin is commonly used to treat various conditions including nerve pain, fibromyalgia, anxiety disorders, and is being studied for post-COVID chronic fatigue syndrome. The medication influences pain and fatigue perception by modifying the way the brain processes these signals, making it a promising option for managing post-viral fatigue symptoms.

Investigated diseases

Chronic Fatigue Syndrome (CFS) associated with Post-COVID Syndrome - A complex condition that develops after COVID-19 infection, characterized by severe fatigue that doesn't improve with rest. Patients experience persistent exhaustion that significantly affects daily activities and can last for months. The condition often includes other symptoms such as muscle weakness, difficulty with concentration and memory, sleep problems, and reduced physical endurance. The fatigue typically worsens with physical or mental activity. The condition can fluctuate in intensity over time, with periods of increased and decreased severity.