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Tests treatment safety and results for Nervous System Diseases
Official title Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of Tianeptine in the Treatment of Covid Fog Symptoms in Patients After COVID-19.
ClinicalTrials.gov ID: NCT06012552
What this study is testing
What is Tianeptine?
Tianeptine is an investigational medicine, being studied as a potential treatment for nervous system diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- COVID-19 is associated with a high risk of complications from the central nervous system. Syndrome of cognitive disorders- in terms of memory, attention or executive functions among COVID-19 convalescents is often called brain fog (covid fog - CF).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent from the patient to participate in the clinical trial.
- Age ≥ 18 years.
- History of COVID-19 infection confirmed by a positive SARS-CoV-2 test result by RT- PCR or positive antigen test.
- Subjective patient-reported cognitive decline after COVID-19 infection at Screening.
- Cognitive dysfunction found at Screening, defined by the Montreal Scale for the Assessment of Cognitive Function (MoCA) as a score of less than 26.
You likely can't join if
- Hypersensitivity to tianeptine.
- Hypersensitivity to fluorodesoxyglucose (FDG).
- History of allergy to drugs or other substances, which, in the Investigator's opinion, is a contraindication to participation in the study.
- History of stroke.
- Ever undergone and planned brain surgery at the time of the study.
- Previously diagnosed organic damage to the central nervous system.
See the full eligibility criteria
- Written informed consent from the patient to participate in the clinical trial.
- Age ≥ 18 years.
- History of COVID-19 infection confirmed by a positive SARS-CoV-2 test result by RT- PCR or positive antigen test.
- Subjective patient-reported cognitive decline after COVID-19 infection at Screening.
- Cognitive dysfunction found at Screening, defined by the Montreal Scale for the Assessment of Cognitive Function (MoCA) as a score of less than 26.
- Use of effective contraception by women of childbearing potential.
- Hypersensitivity to tianeptine.
- Hypersensitivity to fluorodesoxyglucose (FDG).
- History of allergy to drugs or other substances, which, in the Investigator's opinion, is a contraindication to participation in the study.
- History of stroke.
- Ever undergone and planned brain surgery at the time of the study.
- Previously diagnosed organic damage to the central nervous system.
- Diagnosed organic mental disorder.
- Diagnosed bipolar affective disorder.
- Diagnosed psychotic disorder.
- History of active depressive episode, including those diagnosed at the time of study eligibility, requiring antidepressant treatment.
- Diagnosed mental retardation.
- Bipolar affective disorder in a first-degree relative.
- Uncontrolled diabetes mellitus.
- Severe renal failure with eGFR \< 30ml/min/1.73 m2.
- cirrhosis of liver Severe liver cirrhosis (Child-Pugh class C ).
- Claustrophobia.
- Diagnosed chronic diseases that significantly worsen the patient's prognosis and quality of life, which, in the Investigator's opinion, may adversely affect the patient's participation in the study.
- Active or past malignancy within the past 5 years, except for basal cell carcinoma of the skin and cervical cancer in situ in patients who have received radical treatment.
- Active viral, bacterial, fungal, tuberculous, or parasitic infection.
- History or presence of other relevant diseases which, in the Investigator's opinion, is a contraindication to participation in the study.
- Positive pregnancy test performed on women of childbearing potential at screening or Visit 1.
- Taking medications:
- Non-selective MAO inhibitors within 14 days prior to screening,
- Mianserin during screening.
- Significant difficulty with peripheral venous cannulation.
- Positive history of alcohol, drug, and psychoactive abuse/dependence.
- Pregnancy or planning a pregnancy during the study period.
- Breastfeeding or planning to breastfeed during the study period.
- Current participation in another clinical trial.
- Lack of patient compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.