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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. (COVMENT)

Primary Purpose

Nervous System Diseases

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Tianeptine
Placebo
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nervous System Diseases focused on measuring COVID-19, memory problems, Covid Fog, brain fog, COVID-19 brain fog, lack of mental clarity, poor concentration, headaches, confusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Anna KlimkiewiczRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stady group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improvement in covid fog symptoms
Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.

Secondary Outcome Measures

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).
Change in brain metabolic activity
Change in brain metabolic activity as assessed by PET-CT at week 16 after randomization.

Full Information

First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Military Institute od Medicine National Research Institute
Collaborators
ABM Industries
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1. Study Identification

Unique Protocol Identification Number
NCT06012552
Brief 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.
Acronym
COVMENT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Institute od Medicine National Research Institute
Collaborators
ABM Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nervous System Diseases
Keywords
COVID-19, memory problems, Covid Fog, brain fog, COVID-19 brain fog, lack of mental clarity, poor concentration, headaches, confusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stady group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tianeptine
Intervention Description
Tianesal 12,5mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
application as in the control group
Primary Outcome Measure Information:
Title
Improvement in covid fog symptoms
Description
Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.
Time Frame
16 week after randomization
Secondary Outcome Measure Information:
Title
improving cognitive function
Description
Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26 - 30 points).
Time Frame
16 week after randomization
Title
Change in brain metabolic activity
Description
Change in brain metabolic activity as assessed by PET-CT at week 16 after randomization.
Time Frame
16 week after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Klimkiewicz, MD, PhD
Phone
+48695723984
Email
aklimkiewicz@wim.mil.pl
Facility Information:
Facility Name
Anna Klimkiewicz
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Klimkiewicz, MD, PhD
Phone
+48695723984
Email
aklimkiewicz@wim.mil.pl

12. IPD Sharing Statement

Learn more about this trial

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.

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