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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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.

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.

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. (NCT06012552) is a Phase 2 interventional studying Nervous System Diseases, sponsored by Military Institute od Medicine National Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 convalescents is often called brain fog (covid fog - CF). CF leads to psychomotor retardation and chronic fatigue syndrome, resulting in poor functioning and low 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 the preliminary assessment authors found that 83% of COVID-19 inpatients had at least mild cognitive impairment. Moreover, SARS-CoV-2 infection is associated with higher incidence of depression and anxiety disorders. CF pathogenesis is not fully understood. There exist no strict diagnostic criteria for it, as well as no therapeutic recommendations. Health care systems of many countries, including Poland, lack therapeutic programs addressed at patients with CF. Tianeptine may be a drug with potentially beneficial effects in CF. Neuroprotective, antidepressive, sleep-improving and anxiolytic properties of tianeptine allow it to choose as a candidate for CF amelioration. There is also data supporting the thesis that patients with CF may benefit from short-term group therapy. It has been proven to improve quality of life, reduce stress, and improve cognitive function in non-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: the duration of disorders, response to therapy, the final result of treatment. Among the markers of CNS damage, those which correlates with the patient's condition will be selected. The study will allow to estimate the prevalence of CF in the population. PET-CT and auditory 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 participants as a result of rehabilitation and psychotherapy. Additional improvement is expected in the tianeptine group. Improvement will be defined as: reduction in the severity of anxiety and depression disorders, reduction in the severity of cognitive disorders, improvement in the quality of life. The results will be used to develop a new diagnostic and therapeutic pathway and a comprehensive intervention program in CF.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nervous System Diseases and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 140 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nervous System Diseases subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Written willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Tianeptine

Tianesal 12,5mg

DRUG

Placebo

application as in the control group

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Anna Klimkiewicz
Warsaw, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06012552), the sponsor (Military Institute od Medicine National Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06012552 clinical trial studying?

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 convalescents is often called brain fog (covid fog - CF). CF leads to psychomotor retardation and chronic fatigue syndrome, resulting in poor functioning and low 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 the preliminary assessment authors found that 83% of COVID-19 inpatients had at least mild … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06012552?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06012552?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06012552. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06012552. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.