Investigator-initiated clinical trial on the effect of fluvoxamine to prevent exacerbation of COVID-19

Phase 2

Recruiting

• Conditions: COVID-19; D000086382

• Registration Number: JPRN-jRCT2031220558
• Lead Sponsor: iitsu Tomihisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients who meet all of the following conditions are eligible.
1) Patients with symptoms of mild to moderate I (no respiratory failure) (corresponding to scores 1 and 2 of the primary endpoint) in the Guidelines for medical care for new coronavirus infection (COVID-19) (version 8.1).
2) Patients with confirmed fever (37.5 degree or higher) within 72 hours prior to obtaining consent.
3) Patients with one or more of the following symptoms at the time of screening
Cough, shortness of breath, myalgia, nasal discharge, sore throat, headache, nausea/vomiting, abdominal pain, diarrhea, anosmia (loss of sense of smell), loss of taste (loss of taste)
4) Patients whose SARS-CoV-2 was detected by PCR test (nucleic acid amplification method) or antigen test from samples derived from the upper and lower respiratory tract within 3 days before obtaining informed consent.
5) Patients of Japanese nationality who are at least 25 years of age at the time of consent.
6) Patients who have given their voluntary written informed consent after receiving a sufficient explanation regarding their participation in this clinical trial.

Exclusion Criteria

Those who meet any of the following conditions are not eligible.
1) Patients who have passed more than 8 days from symptom onset to registration.
2) Patients with a percutaneous arterial oxygen saturation (SpO2) of 93% or less.
3) Suicidal patients who meet any of the following criteria:
- Subjects who currently or within the past 6 months had suicidal ideation with any form of suicidal intention according to the Columbia Suicide Rating Scale (C-SSRS). (Item 4 [Some intention to commit suicide but no specific plan] or Item 5 [Active suicidal ideation - with specific plan and intention] equals YES. Only subjects who meet only Item 1 to Item 3 in the suicidal ideation section can be enrolled at the discretion of the investigator or subinvestigator.)
- Subjects who have experienced any suicidal behavior according to C-SSRS within the past year.
4) Patients with psychiatric disorders such as schizophrenia, mood disorders (bipolar disorder and depression), and personality disorders, and patients with a history of them.
5) Patients with convulsive diseases such as epilepsy or a history of these diseases.
6) Patients with cerebral organic disorders or comorbid disorders with high impulsivity.
7) Patients with severe heart disease (fatal arrhythmia, pacemaker-introduced patients).
8) Patients with a history or complication of malignant tumor. However, patients who have a history but have not recurred for 5 years or more can be registered.
9) Patients with a history of bleeding disorders or a bleeding diathesis.
10) Patients with glaucoma or intraocular hypertension.
11) Dialysis patients with severe renal dysfunction.
12) Patients with severe hepatic dysfunction (AST or ALT exceeding 5 times the institution standard).
13) Patients with uncontrolled diabetes mellitus (diabetic patients with HbA1c 9.0% or more despite being treated for diabetes).
14) Women who are breastfeeding, pregnant, or may become pregnant.
15) Immunocompromised (organ transplantation, bone marrow transplantation, AIDS, biologics and/or high-dose steroids (>20 mg prednisolone per day)).
16)Patients who are receiving drugs that are contraindicated for fluvoxamine (pimozide, tizanidine hydrochloride, ramelteon, melatonin).
17) Patients within 4 weeks after discontinuation of fluvoxamine.
18) Patients with a history of serotonin syndrome.
19) Patients who are receiving monoamine oxidase (MAO) inhibitors (selegiline hydrochloride, rasagiline mesylate, safinamide mesylate), drugs with serotonergic effects that may cause serotonin syndrome, or within 2 weeks after discontinuation .
20)Patients who are on or within 2 weeks after discontinuation of psychotropic drugs that have or may have agonist/antagonist effects on sigma-1 receptors.
21)Patients who are receiving approved drugs for the treatment of COVID-19 mild to moderate I, or within 2 weeks after discontinuing the drug.
22) Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable for the safe conduct of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A score of 3 or higher (SpO2 =< 93%, but oxygen is not administered) is defined as clinical exacerbation and the exacerbation rate is evaluated.<br><br>[Criteria for clinical symptom assessment score]<br>(0) SpO2>=96% without subjective symptoms.<br>(1) Subjective symptoms but SpO2>=96%.<br>(2) 93%<SpO2<96% regardless of subjective symptoms.<br>(3) SpO2 =< 93%, but oxygen is not administered.<br>(4) SpO2 =< 93% and oxygen is being administered.<br>(5) Using non-invasive ventilation or high-flow oxygen equipment.<br>(6) Management by invasive mechanical ventilation or ECMO.<br>(7) Death