Long COVID Long COVID, Post-COVID-19 Condition
Conditions
Interventions
After the study is explained and consent is obtained, subjects will be randomized and assigned to a dosage group (placebo, clomipramine 20 mg, clomipramine 40 mg). Study subjects will begin receiving
Sponsors
Noda Takamasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following selection criteria and who have obtained sufficient understanding and written consent from the research subject about the contents of this research are eligible for this research. 1) Participants must be meet the WHO-defined Long COVID 2) On the C19-YRSm First Assessment (fatigue score) on > 2 points more severe than their pre-COVID baseline 3) On the FSS First Assessment on > 28 points 4) 18 to 59 years old 5) Participants attending the outpatient clinic of the research facility 6) Participants are competent to consent and consent is obtained in writing
Exclusion criteria
Exclusion criteria: Any potential subject who meets the following criteria will be excluded from participating in the study. 1) Have a history of mood disorders, schizophrenia, anxiety disorder, OCD or alcohol or substance use disorders 2)Taking antidepressants, antipsychotics medications 3) Participant has contraindications to taking clomipramine 4)Contraindications for use (a) Patients with angle-closure glaucoma (b) Patients with a history of hypersensitivity to the components of clomipramine or tricyclic antidepressants (c) Patients in the early stages of recovery from myocardial infarction (d) Patients with urinary retention (e) Patients currently receiving or within 2 weeks of discontinuing MAO inhibitors (selegiline hydrochloride, rasagiline mesylate, safinamide mesylate) (f) Patients with long QT syndrome 5) Patients who have had a change in prescription between 2 weeks prior to the study participation period and study registration 6) Patients using prohibited concomitant drugs or therapies 7) Patients with clinically significant abnormalities in the results of safety laboratory tests (including liver and renal function tests, blood counts, and biochemistry tests), including the following: (a) AST and ALT levels 3 times or higher than the upper limit of normal (b) Serum creatinine levels 2 times or higher than the upper limit of normal 8) Pregnant women, women who wish to become pregnant, or women who are breastfeeding 9) Patients whose native language is not Japanese 10) Patients participating in other clinical research 11) Patients who the principal investigator and co-investigator deem inappropriate as study subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fatigue Severity Scale total score 8 weeks after starting clomipramine treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation 1) Evaluation of post-COVID symptom severity C19-YRSm (Modified COVID-19 Yorkshire Rehabilitation Screening) 2) Evaluation of general health SF-36v2 (MOS Short-Form 36-Item Health Survey) 3) CGI (Clinical Global Impression) 4) FSS total score (change at 2, 4weeks after starting clomipramine administration) 5) Each subscale of SF-36v2 6) Number of days until FSS total score is 58.5 or less and 40.5 or less 7) Physical function evaluation 6-min walk test 8) Cognitive function assessment THINC-it (memory, attention, concentration, working memory, executive function) 9) Neuropsychiatric assessment (self-report assessment) GAD-7 (anxiety), PHQ-9 (depression), ISI (insomnia), EQ-5D-5L (QOL) Safety assessment 1) UKU Adverse Reaction Assessment Scale 2) Adverse events 3) Clinical test values (hematological tests, blood biochemistry tests) | — |
Contacts
Public ContactTakamasa Noda
National Center of Neurology and Psychiatry (NCNP)
Outcome results
None listed