A single-center randomized controlled trial of clomipramine hydrochloride for post-COVID-19 symptoms

JRCT ID: jRCTs031240334

Registered date:12/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Long COVID
• Date of first enrollment: 12/09/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 the overencapsulated study drug within 14 days of consenting to participate. Study drug administration will continue until 8 weeks after the start of treatment or until the decision to discontinue, whichever comes first. Efficacy and safety evaluations will be performed before the start of treatment and 1, 2, 3, 4, and 8 weeks after the start of treatment. Except in cases of consent withdrawal, death, or inability to evaluate, fatigue scores (Fatigue Severity Scale), the primary endpoint, will be performed at 2, 4, and 8 weeks.

Outcome(s)

• Primary Outcome: Change in Fatigue Severity Scale total score 8 weeks after starting clomipramine treatment

Secondary Outcome

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, prolactin)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Both

Include 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

Exclude 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) There is a change in a regular prescription drug during the period from 2 weeks before the study participation period to the end
6) Pregnant or lactating
7) Not a native Japanese speaker
8)Patients participating in other clinical studies
9) Participant considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study.

Related Information

• Primary Sponsor: Noda Takamasa
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,SENSHIN Medical Research Foundation