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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 with the study of the pathophysiology of the phenomenon using positron emission tomography, biochemical, immunological and electrophysiological parameters (COVMENT).

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510790-19-00
Acronym
ABM/COVMENT/2021
Enrollment
140
Registered
2024-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid fog - a dysfunctional condition characterized by slowed thinking, disorientation, difficulty remembering, impaired attention and concentration.

Brief summary

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

Detailed description

Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26 - 30 points)., A 10% improvement in raw test scores covering various domains of cognitive functioning at week 16 after randomization: a) CTT, b) COWAT, c) SCWT, d) Repeating Digits from the WAIS-R, e) Digit symbols from WAIS-R., A 10% improvement in ECog-12 test raw scores at week 16 after randomization., Improvement in subjectively assessed depressive symptom severity defined as PHQ score < 5 points at week 16 after randomization., Improvement in subjectively assessed severity of anxiety symptoms defined as GAD-7 score<5 points at 16 weeks after randomization., Improvement in subjectively assessed severity of sleep difficulties defined as AIS score <6 points at 16 weeks after randomization., Improvement in subjectively assessed severity of loneliness defined as SLS score <5 points at 16 weeks after randomization., Reduction in severity or resolution of depressive symptoms as assessed by the MADRS scale. Resolution of symptoms will be defined as a MADRS score < 9 points.

Interventions

DRUGPlacebo
DRUGTianesal
DRUG12
DRUG5 mg

Sponsors

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26 - 30 points)., A 10% improvement in raw test scores covering various domains of cognitive functioning at week 16 after randomization: a) CTT, b) COWAT, c) SCWT, d) Repeating Digits from the WAIS-R, e) Digit symbols from WAIS-R., A 10% improvement in ECog-12 test raw scores at week 16 after randomization., Improvement in subjectively assessed depressive symptom severity defined as PHQ score < 5 points at week 16 after randomization., Improvement in subjectively assessed severity of anxiety symptoms defined as GAD-7 score<5 points at 16 weeks after randomization., Improvement in subjectively assessed severity of sleep difficulties defined as AIS score <6 points at 16 weeks after randomization., Improvement in subjectively assessed severity of loneliness defined as SLS score <5 points at 16 weeks after randomization., Reduction in severity or resolution of dep

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026