ABSTRACT
Condition:
COVID-19COVID-19;D000086382;COVID-19
Intervention:
[Test treatment group]"Fluvoxamine maleate (25mg) + lactose capsule"
Administer a single initial daily dose of 50 mg (2 capsules of 25 mg) orally. From the next day, 75 mg once (3 capsules of 25 mg), twice daily orally, 150 mg (6 capsules of 25 mg)/day.
[Control group (placebo)]
"lactose capsule"
Placebo (2 capsules) is orally administered once daily for the first dose. From the next day, once a placebo (3 capsules) will be administered orally twice a day, 6 capsules/day.;D016666;Fluvoxamine
Primary outcome:
A score of 3 or higher (SpO2 =< 93%, but oxygen is not administered) is defined as "clinical exacerbation" and the exacerbation rate is evaluated.[Criteria for clinical symptom assessment score]
(0) SpO2>=96% without subjective symptoms.
(1) Subjective symptoms but SpO2>=96%.
(2) 93%
(4) SpO2 =< 93% and oxygen is being administered.
(5) Using non-invasive ventilation or high-flow oxygen equipment.
(6) Management by invasive mechanical ventilation or ECMO.
(7) Death
Criteria:
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) At the time of screening, in addition to fever (37.5 deg C or higher), symptoms accompanied by one or more of the following symptoms:
Cough, shortness of breath, muscle pain, nasal discharge, sore throat, headache, nausea/vomiting, abdominal pain, diarrhea, anosmia (loss of smell), loss of taste (loss of taste)
3) 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.
4) Japanese adults aged 50 years or older at the time of informed consent, or persons aged 40 or older who are at risk of aggravation (regardless of gender, Japanese nationals).
5) 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.
ABSTRACT
BACKGROUND: To control the spread of the new SARS-CoV-2 infection's disease (COVID-19), appropriate precautionary behaviors by the public should be promoted. There are international differences in public cognitive and behavioral pattern, attitudes toward information sources, and anxiety about COVID-19. Information about these differences could increase understanding of the patterns of epidemic-related anxiety and behavior, and would help optimize future policies for preventing the next wave of the epidemic. METHODS: To examine between-country differences in perception, attitude, and precautionary behaviors toward COVID-19, we conducted a cross-sectional study using an online questionnaire survey. Participants were adults who had been registered in Cross Marketing Group Inc. and living in the UK, Spain, or Japan. A total of 8,000 people stratified by age were recruited on a first-come, first-serve basis. Knowledge of and anxiety about COVID-19, the frequency of access and perceived credibility of several information sources, and the frequency of each precautionary behavior were examined on March 27-28, 2020, in Japan and April 17-21, 2020, in the UK and Spain. RESULTS: Knowledge, anxiety, and the frequency of precautionary behaviors were higher in the UK and Spain than in Japan. Participants with infected acquaintances were more concerned about COVID-19. However, participants in the UK rarely wore a medical mask. Participants in the UK and Spain were more eager to obtain information about COVID-19 than those in Japan. Participants in Spain tended not to trust official information and to believe specialists' comments instead. CONCLUSION: The rapidity of the spread of COVID-19, cultural background, and recent political situations seemed to contribute to the international differences here.
ABSTRACT
BACKGROUND: The novel corona virus infection (COVID-19) quickly became a pandemic state. Identifying characteristics of "possible super spreaders", suggested as a dominant cause of rapid spreading transmission, will help us to design proper prevention strategies. METHODS: We conducted a nation-wide online survey to investigate the relationship of perception and anxiety levels about COVID-19 to the possible risk behaviors for spread of the virus in Japan. We recruited a total of 4,000 citizens, who responded to the questionnaire including several questions regarding the level of fear and anxiety about COVID-19, infection preventive behaviors and access to media with trust level about the virus as well as some demographic and socioeconomic data during March 27th and 28th, 2020. FINDINGS: Thirteen-point-three percent of the participants rated "1" on a nine-point Likert with respect to the knowledge about COVID-19. Ten-point-one percent and 11.7% presented no anxiety of being infected and transmission to others. Ten-point-eight percent showed no worry about symptomatic aggravation. Eight-point-one percent had no serious concern about expanding infection. The distribution of these items was highly correlated with each other. Participants with the low level of knowledge about COVID-19 were likely to less frequently access any information sources and neither trust them. They were less anxious about their health status, and less likely to put precautionary behaviors such as washing hands and avoiding crowded spaces, suggested by statistical analyses. INTERPRETATION: The present study suggests that it is greatly important to enlighten those have no concerns about this crisis of COVID-19 and modify their risk behavior via various ways, in order to prevent and control this viral pandemic. FUNDING: This study was funded by the management grand provided to Chiba University Graduate School of Medicine and the Japan Society for the Promotion of Science KAKENHI grants.