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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 with the study of the pathophysiology of the phenomenon using positron emission tomography, biochemical, immunological and electrophysiological parameters (COVMENT).
EU CTIS ID: 2024-510790-19-00
What this study is testing
To compare the efficacy of tianeptine versus placebo in the treatment of covid fog symptoms in post COVID-19 patients. Additional research objective: To determine the pathophysiology of the covid fog phenomenon based on differences in neuropsychological, ENT, neurological, psychiatric, and laboratory test results between post-covid patients with covid fog symptoms and those without covid fog symptoms. To assess changes over time in treatment of neuropsychological, laryngological, neurological, psychiatric, laboratory, and PET-CT findings in patients with covid fog.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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.
- Use of effective contraception by women of childbearing potential.
You likely can't join if
- Hypersensitivity to tianeptine.
- Depression with active symptoms requiring initiation or modification of 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.
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.
- Depression with active symptoms requiring initiation or modification of 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.
- Hypersensitivity to fluorodesoxyglucose (FDG).
- 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.
- Taking medications: (a) Non-selective MAO inhibitors within 14 days prior to screening, (b) 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. Unless taking the investigational product or using the medical device was completed 90 days or 5 x t1/2 before screening.
- Lack of patient compliance.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.