Testing Tianeptine for treating cognitive issues after COVID-19.

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.

This study is testing if Tianeptine can help adults who have recovered from COVID-19 and are experiencing 'Covid Fog' feel better and think more clearly.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Military Institute od Medicine National Research Institute (Academic / other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT06012552 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Tianeptine in alleviating cognitive dysfunction, commonly referred to as 'Covid Fog', in patients who have recovered from COVID-19. The study is randomized, double-blind, and placebo-controlled, ensuring that neither the participants nor the researchers know who receives the treatment or the placebo. Eligible participants are adults with a confirmed history of COVID-19 and self-reported cognitive decline, assessed using the Montreal Scale for the Assessment of Cognitive Function. The trial aims to address a significant gap in therapeutic options for cognitive impairments following COVID-19.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced cognitive decline after a confirmed COVID-19 infection.

Not a fit: Patients with a history of stroke or diagnosed organic mental disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients suffering from Covid Fog.

How similar studies have performed: While there is limited research specifically on Tianeptine for Covid Fog, similar studies addressing cognitive dysfunction post-COVID-19 have shown promise in exploring treatment options.

Eligibility criteria

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.

Where this trial is running

Warsaw

• Anna Klimkiewicz — Warsaw, Poland (Recruiting)

Study contacts

• Study coordinator: Anna Klimkiewicz, MD, PhD

Conditions Nervous System Diseases; COVID-19; memory problems; Covid Fog; brain fog; COVID-19 brain fog; lack of mental clarity; poor concentration