Status:
RECRUITING
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.
Lead Sponsor:
Military Institute od Medicine National Research Institute
Collaborating Sponsors:
ABM Industries
Conditions:
Nervous System Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 convalesc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06012552
Start Date
February 17 2023
End Date
October 31 2027
Last Update
August 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Anna Klimkiewicz
Warsaw, Poland