Nervous System DiseasesPhase 2COVMENTNCT06012552
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.
A Phase 2 study testing Tianeptine in people with Nervous System Diseases, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial 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 convalescents is often called brain fog (covid fog - CF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- Tianeptine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- 17 Feb 2023to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Anna Klimkiewicz
Warsaw
Anna Klimkiewicz, MD, PhD, +48695723984, aklimkiewicz@wim.mil.pl
About this study
Official title: 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.
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.
Read more
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.
- Conditions
- Nervous System Diseases
- Being tested
- Tianeptine, Placebo
- Keywords
- COVID-19, memory problems, Covid Fog, brain fog, COVID-19 brain fog, lack of mental clarity, poor concentration, headaches, confusion
- Medical subject headings
- Nervous System Diseases, COVID-19, Memory Disorders, Mental Fatigue, Headache, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TianeptineDrug
Tianesal 12,5mg
PlaceboDrug
application as in the control group
| Study group | Role | What they receive |
|---|---|---|
| Stady group | Experimental | The study group will receive oral tianeptine in a dose of 3x 12.5 mg per day (patients younger than 70) or 2x 12.5 mg per day (patients older than 70) for 16 weeks. In addition, the subjects will participate in group psychotherapy and neurological rehabilitation. Receives: Drug: Tianeptine |
| Control group | Placebo comparator | The control group will receive oral placebo in a dose of 3x 12.5 mg per day (patients younger than 70) or 2x 12.5 mg per day (patients older than 70) for 16 weeks. In addition, the subjects will participate in group psychotherapy and neurological rehabilitation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in covid fog symptoms
Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.
Measured: 16 week after randomization
Secondary outcomes (2)
improving cognitive function
Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26
- 30 points).
Measured: 16 week after randomization
Change in brain metabolic activity
Change in brain metabolic activity as assessed by PET-CT at week 16 after randomization.
Measured: 16 week after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start17 Feb 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ABM Industries
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012552
- Sponsor's protocol ID
- ABM/COVMENT/2021
- Other IDs
- 2022-000893-25
- Acronym
- COVMENT
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06012552
- Acronym / sponsor ID
- COVMENT / ABM/COVMENT/2021
- Conditions
- Nervous System Diseases
- Keywords
- COVID-19, memory problems, Covid Fog, brain fog, COVID-19 brain fog, lack of mental clarity, poor concentration, headaches
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Collaborators
- ABM Industries
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stady group | Experimental | Drug: TianeptineThe study group will receive oral tianeptine in a dose of 3x 12.5 mg per day (patients younger than 70) or 2x 12.5 mg per day (patients older than 70) for 16 weeks. In addition, the subjects will participate in group psychotherapy and neurological rehabilitation. |
| Control group | Placebo comparator | Drug: PlaceboThe control group will receive oral placebo in a dose of 3x 12.5 mg per day (patients younger than 70) or 2x 12.5 mg per day (patients older than 70) for 16 weeks. In addition, the subjects will participate in group psychotherapy and neurological rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TianeptineTianesal 12,5mg | Drug | Stady group |
| Placeboapplication as in the control group | Drug | Control group |
Primary outcome
Improvement in covid fog symptoms
Time frame: 16 week after randomization
Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.
2 secondary outcomes
improving cognitive function
Time frame: 16 week after randomization
Change in brain metabolic activity
Time frame: 16 week after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tianeptine in people with Nervous System Diseases, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Klimkiewicz, MD, PhD (+48695723984, aklimkiewicz@wim.mil.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in covid fog symptoms (time frame: 16 week after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.