Study on the Effectiveness of 2LEBV and 2LXFS for Reducing Fatigue in Patients with Epstein-Barr Virus Infection

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What is this study about?

This clinical trial is focused on studying the effects of two treatments, 2LEBV and 2LXFS, on fatigue in patients with an Epstein-Barr Virus (EBV) infection. EBV is a common virus that can cause symptoms like tiredness, fever, and sore throat. The study aims to compare how well these treatments work in reducing fatigue compared to a placebo. The treatments contain various substances, including deoxyribonucleic acid (DNA), interleukin-1, interleukin-2, and interferon alfa, which are involved in immune system responses.

Participants in the study will be randomly assigned to receive either the 2LEBV treatment, the 2LXFS treatment, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will last for a period of six months, during which participants will take the treatment as directed and attend regular check-ups to monitor their progress and any changes in their symptoms.

The main goal of the study is to assess the severity of fatigue at the end of the treatment period. Participants will complete questionnaires to evaluate their level of fatigue and other related symptoms. The study will also monitor the safety of the treatments by recording any side effects that occur. By the end of the study, researchers hope to determine whether 2LEBV or 2LXFS can effectively reduce fatigue in patients with an EBV infection compared to a placebo.

1 initial visit and screening

The initial visit involves a comprehensive screening process to confirm eligibility for the study. This includes a serology test to check for Epstein-Barr Virus (EBV) antibodies and lymphocyte typing to assess immune status.

Participants must have experienced significant fatigue for at least one month and present with at least two additional symptoms such as fever, sore throat, or muscle weakness.

2 randomization and treatment allocation

Participants are randomly assigned to one of three groups: the 2LEBV group, the 2LXFS group, or the placebo group. This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

The treatment involves taking the assigned medication in pill form through oromucosal use, which means it is absorbed through the mouth’s mucous membranes.

3 treatment phase

Participants take the assigned medication as directed for the duration of the study. The specific dosage and frequency are determined by the study protocol and are consistent throughout the treatment phase.

Regular monitoring occurs to assess the treatment’s impact on fatigue and other symptoms related to EBV infection.

4 mid-study evaluation

At the midpoint of the study, participants undergo evaluations to measure physical fatigue, activity levels, motivation, and mental fatigue using the MFI-20 questionnaire.

Additional assessments include checking for any changes in EBV-related symptoms and monitoring immune status through lymphocyte typing.

5 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted. This includes completing the MFI-20 questionnaire to assess general fatigue and other related scales.

Participants are also evaluated for any adverse events that may have occurred during the study.

6 follow-up visit

A follow-up visit is scheduled to monitor the long-term effects of the treatment and to ensure participant safety.

This visit includes a final assessment of fatigue levels and any remaining EBV-related symptoms.

Who Can Join the Study?

The patient can be male or female and must be 12 years old or older.
The patient must have significant fatigue (extreme tiredness) for at least 1 month.
The patient must have at least two other symptoms, such as:
- Long-lasting exhaustion even after light activity
- Subfebrile state (slightly elevated body temperature)
- Fever
- Loss of appetite
- Nausea (feeling sick to the stomach)
- Angina (chest pain)
- Conjunctivitis (eye inflammation)
- Sensitive cervical or axillary lymph nodes (swollen glands in the neck or underarms)
- Erythematous and swollen tonsils (red and swollen tonsils)
- Headaches
- Sore throat
- Myalgia (muscle pain)
- Muscular weakness
- Arthralgia (joint pain)
- Splenomegaly (enlarged spleen)
- Visual disorders (problems with vision)
- Memory disorders
- Attention deficit disorders
- Sleep disorders
- Gastrointestinal disorders (stomach or digestion problems)
- Breathing disorders
- Cardiovascular disorders (heart or blood vessel problems)
The patient (and parent/legal representative if necessary) must agree to have a serology test (a blood test to check for antibodies) for the study.
The patient (and parent/legal representative if necessary) must agree to have lymphocytes typing (a test to check certain white blood cells) for the study.
The patient (and parent/legal representative if necessary) must be able to understand and follow the study requirements.
The patient (and parent/legal representative if necessary) must sign the Informed Consent Form (a document explaining the study and agreeing to participate).
The patient must have a positive serology for EBV (Epstein-Barr Virus), meaning they have antibodies (IgG and/or IgM) indicating a current or past infection.

Who Cannot Join the Study?

Individuals who do not have an Epstein-Barr Virus infection cannot participate. This is a type of virus that can cause certain illnesses.
Participants must be within specific age ranges, which are not specified here.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals considered part of a vulnerable population are not excluded, meaning they can participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Private practice of Dr MALLYA Flotea	Antwerp	Belgium
Pmxydyz pqkqsgzw oc Dw Lmldqm Tsdye	Waregem	Belgium
Pjoboag ppetxidj ot De Dntrsbu Pxpzvzvog	Heule	Belgium
Ppjdumm plkldboc ox Db Mcfpsx Ezin	Stavelot	Belgium
Pyfvihe pomraomb oi Dc Fsgrjqsezz Atewljzsjohrk	Antwerp	Belgium
Pdhrffg piacimos og Ds Shzrscvl Vfqol	Brussels	Belgium
Pvvrwha prqscdvu op Do Buhqxss Igkw	Aartselaar	Belgium
Ptnkgai pvpyjmlr os Dx Seiigpii Hqkozo	Marche-en-Famenne	Belgium
Picpeeg pcxkysbr oy Dd Hgopwrp Jyyhypyn	Brussels	Belgium
Pmegebk pzvoyfzg oo Dd Abwg Mfvbefs	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	11.11.2020

Trial locations

Investigated drugs:

2LEBV® is a medication being studied for its potential to reduce fatigue in patients who have an Epstein-Barr Virus (EBV) infection. The trial aims to determine how effective this treatment is in alleviating the severity of fatigue compared to not receiving the active treatment.

2LXFS® is another medication involved in the study, which is being tested in combination with 2LEBV®. This combination is also being evaluated for its ability to reduce fatigue in patients with an EBV infection. The goal is to see if this combination is more effective than not receiving the active treatment.

Epstein-Barr Virus infection – Epstein-Barr Virus (EBV) infection is a common viral illness that often causes symptoms similar to those of the flu. It is most known for causing infectious mononucleosis, also known as “mono” or the “kissing disease.” The virus is transmitted through bodily fluids, primarily saliva. Symptoms can include fatigue, fever, sore throat, swollen lymph nodes, and sometimes an enlarged spleen or liver. The infection can lead to prolonged fatigue and other symptoms such as headaches, muscle aches, and joint pain. While the initial symptoms may resolve within a few weeks, some individuals experience lingering fatigue and other symptoms for months.

Trial ID:

2024-514222-24-00

NCT ID:

NCT04308278

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of 2LEBV and 2LXFS for Reducing Fatigue in Patients with Epstein-Barr Virus Infection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?