Fluvoxamine for Adults With Mild to Moderate COVID-19

Inclusion Criteria:

1. Men and women age 18 and older
2. Laboratory-confirmed SARS-CoV-2 patients who have mild to moderate symptoms related toCOVID-19 infection and are admitted to community treatment centers in Seoul, Korea
3. Has symptoms consistent with COVID-19 with onset ≤7 days of randomization

• Currently symptomatic with one or more of the following symptoms: fever, cough,myalgia, shortness of breath, nausea, anorexia, diarrhea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, headache

4. Has laboratory-confirmed SARS-COV-2 infection (positive RT-PCR test) ≤ 3 days ofrandomization
5. Able to provide informed consent

Exclusion Criteria:

1. Severe illness enough to require hospitalization or already meeting the study'sprimary endpoint for clinical deterioration
2. Patients who cannot take oral medication
3. Pregnancy or breastfeeding
4. History of the psychiatric disorder including major depressive disorder
5. Patients who are taking or took selective serotonin reuptake inhibitors, serotonin andnoradrenaline reuptake inhibitor, or tricyclic anti-depressants within 2 weeks
6. Patients who are taking an anti-epileptic drug
7. Patients who are taking co-prescribed drugs (as below) which are contraindicated bymanufacturers due to drug-drug interaction

• Alosetron, tizanidine, theophylline, clozapine, olanzapine (drugs with a narrowtherapeutic index that are primarily metabolized by cytochrome P450 1A2)
• Donepezil, sertraline (sigma-1 receptor agonists)
• Warfarin (increased risk of bleeding)
• Phenytoin (rationale: fluvoxamine inhibits its metabolism)
• Clopidogrel (fluvoxamine inhibits its metabolism from pro-drug to active drugwhich raises the risk of cardiovascular events)
• Monoamine oxidase inhibitors (linezolid, rasagiline, selegiline), triptans (sumatriptan, naratriptan, almotriptan, frovatriptan, zolmitriptan, rizatriptan),lithium, tramadol (rationale: to prevent the possible development of serotoninsyndrome)
• Alprazolam, diazepam (fluvoxamine modestly inhibits the metabolism of thesedrugs): The patient could be enrolled in case of agreeing 25% dose reduction ofthese medications.

8. Already enrolled in another COVID-19 medication trial
9. Medical comorbidities such as severe underlying lung disease (chronic obstructivepulmonary disease on home oxygen, interstitial lung disease, pulmonary hypertension),decompensated cirrhosis, chronic viral hepatitis, congestive heart failure (stage 3 or 4 per patient report and/or medical records), chronic kidney disease, or end-stagerenal disease requiring renal replacement therapy
10. Immunocompromised (solid organ transplant, bone-marrow transplant, acquired immunedeficiency syndrome, on biologics and/or high dose steroids [>20mg prednisone perday])
11. Unable to provide informed consent (e.g., moderate-severe dementia diagnosis)
12. Unable to perform the study procedures (self-assessment of oxygen saturation, bloodpressure, and temperature using self-monitoring equipment)