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 | Recruiting Phase 2

• 2 other identifiers: ABM/COVMENT/20212022-000893-25
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervous System Diseases

Keywords

COVID-19; memory problems; Covid Fog; brain fog; COVID-19 brain fog; lack of mental clarity; poor concentration; headaches; confusion

Outcome Measures

Primary Outcomes (1)

• Improvement in covid fog symptoms

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

  16 week after randomization

Secondary Outcomes (2)

• improving cognitive function

  16 week after randomization

• Change in brain metabolic activity

  16 week after randomization

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Tianeptine DRUG

Tianesal 12,5mg

Stady group

Placebo DRUG

application as in the control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead
• ABM Industries: collaborator

Study Sites (1)

Anna Klimkiewicz

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; COVID-19; Memory Disorders; Mental Fatigue; Headache; Confusion

Interventions

tianeptine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatigue; Behavioral Symptoms; Behavior; Pain

Central Study Contacts

Anna Klimkiewicz, MD, PhD

CONTACT

+48695723984; aklimkiewicz@wim.mil.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 25, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

PL (1)