Drug repositioning of donepezil for the treatment of COVID-19 sequelae. Repositioning for the treatment of psychiatric symptoms

JRCT ID: jRCT2031220510

Registered date:14/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild to moderate COVID-19 patients with fatigue
• Date of first enrollment: 04/01/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Donepezil group
Donepezil 3 mg once daily for 1 week, followed by donepezil 5 mg once daily for 2 weeks.
Placebo group
Lactose 0.6g once daily for 1 week, then lactose 1.0g once daily for 2 weeks.

Outcome(s)

• Primary Outcome: Change of Chalder Fatigue-11 score from the previous observation period to 3 weeks after administration of the study drug, and absolute value of it

Secondary Outcome

1)Changes of Chalder Fatigue-11 score from the pre-treatment period to 8 weeks after treatment with the study drug, and absolute value of it
2)Changes of HADS-A,D scores from the pre-treatment period to 3 weeks and 8 weeks after treatment with the study drug, and absolute value of them
3)Change of IES-R score from the pre-contrast period to 3 weeks and 8 weeks after the administration of the study drug, and absolute value of it
4)Change of EQ5D score from the pre-contamination period to 3 weeks and 8 weeks after the administration of the study drug, and absolute value of it
5)Change of PHQ-9 score from the pre-treatment period to 3 weeks and 8 weeks after treatment with the study drug, and absolute value of it
6)Symptoms including fatigue after 3 weeks and 8 weeks of treatment with the study drug
7)Adverse events
8)Adherence rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Patients who are at least 20 years old and less than 75 years old at the time of obtaining consent.
2) Patients with COVID-19 infection who had upper respiratory tract symptoms or symptoms of fever or cough in the acute phase.
3)Patients who have a bainarization score over 4 on the Chalder Fatigue Score-11 assessment (pre-observation period assessment).
4) Patients with COVID-19 infection confirmed positive by antigen or PCR test and within 52 weeks from the onset of COVID-19 infection to randomization.
5) Patients who have given their consent.

Exclude criteria

1) Patients who have been diagnosed or suspected to have a chronic disease with fatigue, such as psychiatric disease or chronic fatigue syndrome that corresponds to F0 to F3 of ICD-10 in the past.
2) Patients who depend on dialysis or who are likely to start dialysis during the study period.
3) Patients with liver cirrhosis of Child-Pugh C.
4) Patients with respiratory diseases such as COPD and interstitial pneumonia (Hugh-Jones classification over II).
5) Patients with heart failure (NYHA over 2).
6) Patients who are unable to answer the questionnaire (including cognitive impairment).
7) Patients with influenza infection.
8) Patients already taking donepezil or cholinesterase inhibitors.
9) Patients who are allergic to any component of the study drug.
10) Patients with a history of hypersensitivity to piperidine derivatives.
11) Patients who have participated in the same clinical trial in the past.
12) Patients who do not agree with contraception by themselves or their partner during the study period. Patients who give breast-feeding.
13) Other patients who are judged to be inappropriate as subjects by the investigator (co-investigator).

Related Information

• Primary Sponsor: Nakamura Kensuke
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development