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 functionsamong COVID-19 convalescents is often called brain fog (covid fog - CF). CF leads topsychomotor retardation and chronic fatigue syndrome, resulting in poor functioning andlow quality of life. CF may affect up to 81% of patients after COVID-19.Prevalence of CF may be even greater among patients with severe forms of COVID-19. In thepreliminary assessment authors found that 83% of COVID-19 inpatients had at least mildcognitive impairment. Moreover, SARS-CoV-2 infection is associated with higher incidenceof depression and anxiety disorders. CF pathogenesis is not fully understood. There existno strict diagnostic criteria for it, as well as no therapeutic recommendations. Healthcare systems of many countries, including Poland, lack therapeutic programs addressed atpatients with CF. Tianeptine may be a drug with potentially beneficial effects in CF.Neuroprotective, antidepressive, sleep-improving and anxiolytic properties of tianeptineallow it to choose as a candidate for CF amelioration. There is also data supporting thethesis that patients with CF may benefit from short-term group therapy. It has beenproven to improve quality of life, reduce stress, and improve cognitive function innon-MC cognitive disorders.Expected research results: A database will be created from the collected clinical,laboratory and additional data. Statistical models will be created to predict: theduration of disorders, response to therapy, the final result of treatment. Among themarkers of CNS damage, those which correlates with the patient's condition will beselected.The study will allow to estimate the prevalence of CF in the population. PET-CT andauditory evoked potentials also will be used to expand knowledge in the field of CF.Based on the existing data, an improvement is expected in all investigated participantsas a result of rehabilitation and psychotherapy.Additional improvement is expected in the tianeptine group. Improvement will be definedas: reduction in the severity of anxiety and depression disorders, reduction in theseverity of cognitive disorders, improvement in the quality of life. The results will beused to develop a new diagnostic and therapeutic pathway and a comprehensive interventionprogram in CF.
Not Provided
Drug: Tianeptine
Tianesal 12,5mg
Drug: Placebo
application as in the control group
Inclusion 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.
Exclusion Criteria:
- 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:
1. Non-selective MAO inhibitors within 14 days prior to screening,
2. 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.
Anna Klimkiewicz
Warsaw, Poland
Investigator: Anna Klimkiewicz, MD, PhD
Contact: +48695723984
aklimkiewicz@wim.mil.pl
Anna Klimkiewicz, MD, PhD
+48695723984
aklimkiewicz@wim.mil.pl
Not Provided