Tianeptine sodium for Post-COVID cognitive impairment

Inclusion criteria

• {"criterion_text":"- Written informed consent from the patient to participate in the clinical trial."}
• {"criterion_text":"- Age ≥ 18 years."}
• {"criterion_text":"- History of COVID-19 infection confirmed by a positive SARS-CoV-2 test result by RT-PCR or positive antigen test."}
• {"criterion_text":"- Subjective patient-reported cognitive decline after COVID-19 infection at Screening."}
• {"criterion_text":"- Cognitive dysfunction found at Screening, defined by the Montreal Scale for the Assessment of Cognitive Function (MoCA) as a score of less than 26."}
• {"criterion_text":"- Use of effective contraception by women of childbearing potential."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to tianeptine."}
• {"criterion_text":"- Depression with active symptoms requiring initiation or modification of treatment."}
• {"criterion_text":"- Diagnosed mental retardation."}
• {"criterion_text":"- Bipolar affective disorder in a first-degree relative."}
• {"criterion_text":"- Uncontrolled diabetes mellitus."}
• {"criterion_text":"- Severe renal failure with eGFR < 30ml/min/1.73 m2."}
• {"criterion_text":"- Cirrhosis of liver Severe liver cirrhosis (Child-Pugh class C)."}
• {"criterion_text":"- Claustrophobia."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Active viral, bacterial, fungal, tuberculous, or parasitic infection."}
• {"criterion_text":"- Hypersensitivity to fluorodesoxyglucose (FDG)."}
• {"criterion_text":"- History or presence of other relevant diseases which, in the Investigator's opinion, is a contraindication to participation in the study."}
• {"criterion_text":"- Positive pregnancy test performed on women of childbearing potential at screening."}
• {"criterion_text":"- Taking medications: (a) Non-selective MAO inhibitors within 14 days prior to screening, (b) Mianserin during screening."}
• {"criterion_text":"- Significant difficulty with peripheral venous cannulation."}
• {"criterion_text":"- Positive history of alcohol, drug, and psychoactive abuse/dependence."}
• {"criterion_text":"- Pregnancy or planning a pregnancy during the study period."}
• {"criterion_text":"- Breastfeeding or planning to breastfeed during the study period."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Lack of patient compliance."}
• {"criterion_text":"- History of allergy to drugs or other substances, which, in the Investigator's opinion, is a contraindication to participation in the study."}
• {"criterion_text":"- History of stroke."}
• {"criterion_text":"- Ever undergone and planned brain surgery at the time of the study."}
• {"criterion_text":"- Previously diagnosed organic damage to the central nervous system."}
• {"criterion_text":"- Diagnosed organic mental disorder."}
• {"criterion_text":"- Diagnosed bipolar affective disorder."}
• {"criterion_text":"- Diagnosed psychotic disorder."}

Primary endpoints

• {"endpoint_text":"- Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.","definition_or_measurement_approach":"Measured by change in MoCA score: improvement defined as a 2-point increase in MoCA at week 16 after randomization."}

Secondary endpoints

• {"endpoint_text":"- Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26 - 30 points).","definition_or_measurement_approach":"Measured by MoCA score normalization (MoCA 26–30) at week 16 after randomization."}
• {"endpoint_text":"- A 10% improvement in raw test scores covering various domains of cognitive functioning at week 16 after randomization: a) CTT, b) COWAT, c) SCWT, d) Repeating Digits from the WAIS-R, e) Digit symbols from WAIS-R.","definition_or_measurement_approach":"Measured as a ≥10% improvement in raw scores on listed neuropsychological tests at week 16 after randomization."}
• {"endpoint_text":"- A 10% improvement in ECog-12 test raw scores at week 16 after randomization.","definition_or_measurement_approach":"Measured as a ≥10% improvement in ECog-12 raw scores at week 16 after randomization."}
• {"endpoint_text":"- Improvement in subjectively assessed depressive symptom severity defined as PHQ score < 5 points at week 16 after randomization.","definition_or_measurement_approach":"Measured by PHQ score; improvement defined as PHQ < 5 at week 16 after randomization."}
• {"endpoint_text":"- Improvement in subjectively assessed severity of anxiety symptoms defined as GAD-7 score<5 points at 16 weeks after randomization.","definition_or_measurement_approach":"Measured by GAD-7 score; improvement defined as GAD-7 < 5 at week 16 after randomization."}
• {"endpoint_text":"- Improvement in subjectively assessed severity of sleep difficulties defined as AIS score <6 points at 16 weeks after randomization.","definition_or_measurement_approach":"Measured by AIS score; improvement defined as AIS < 6 at week 16 after randomization."}
• {"endpoint_text":"- Improvement in subjectively assessed severity of loneliness defined as SLS score <5 points at 16 weeks after randomization.","definition_or_measurement_approach":"Measured by SLS score; improvement defined as SLS < 5 at week 16 after randomization."}
• {"endpoint_text":"- Reduction in severity or resolution of depressive symptoms as assessed by the MADRS scale. Resolution of symptoms will be defined as a MADRS score < 9 points.","definition_or_measurement_approach":"Measured by MADRS; resolution defined as MADRS < 9."}

Poland

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

52

Number Of Sites

2

Number Of Participants

140

Primary sponsor

Full Name

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Affidea Sp. z o.o.","duties_or_roles":"Medical image analysis- PET CT","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Poland","full_name":"Synevo Sp. z o.o.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Poland","full_name":"Medical University Of Gdansk","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Educational Institution"}