Long COVID Long COVID, post COVID-19 condition
Conditions
Interventions
Take the clomipramine tablet orally once daily, preferably in the morning.
Clinical Global Impressions Scale (CGI) will be performed weekly after the start of administration. If well tolerated, clomip
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 (overall health score) on < 2 points more severe than their pre-COVID baseline 3) 18 to 59 years old 4) Participants attending the outpatient clinic of the research facility 5) Participants are competent to consent and consent is obtained in writing *Symptoms seen in people infected with the SARS-CoV-2, which last for at least two months and cannot be explained by symptoms of other diseases
Exclusion criteria
Exclusion criteria: Any potential subject who meets the following criteria will be excluded from participating in the study. 1) Participant has a history of substance abuse (drug or alchol) or dependence. 2) Participant has contraindications to taking clomipramine 3) Use of prohibited drugs or therapies 4) There is a change in a regular prescription drug during the period from 2 weeks before the study participation period to the registration 5) Pregnant or lactating 6) Not a native Japanese speaker 7) Participant considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome evaluation will be the Safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores for the following indicators at each time points and the score as measured by the change from baseline to each time points. 1) Modified COVID-19 Yorkshire Rehabilitation Screening: C19-YRSm 2) MOS Short-Form 36-Item Health Survey: SF-36v2 3) Fatigue Severity Scale: FSS 4) 6-min walk test: 6MWT 5) THINC-it (Cognitive Assessment and Measurement) 6) Generalized Anxiety Disorder-7: GAD7 7) Patient Health Questionnaire: PHQ-9 8) Insomnia Severity Index Japanese version: ISI-J 9) EuroQol 5 dimensions 5-level: EQ-5D-5L 10) Clinical Global Impressions: CGI | — |
Contacts
Public ContactTakamasa Noda
National Center of Neurology and Psychiatry (NCNP)
Outcome results
None listed