Clinical trial: Fluvoxamine for Adults With Mild to Moderate COVID-19 (NCT04711863)

Eligibility criteria:
Inclusion Criteria:

          1. Men and women age 18 and older

          2. Laboratory-confirmed SARS-CoV-2 patients who have mild to moderate symptoms related to
             COVID-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 of
             randomization

          5. Able to provide informed consent

        Exclusion Criteria:

          1. Severe illness enough to require hospitalization or already meeting the study's
             primary 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 and
             noradrenaline 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 by
             manufacturers due to drug-drug interaction

               -  Alosetron, tizanidine, theophylline, clozapine, olanzapine (drugs with a narrow
                  therapeutic 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 drug
                  which 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 serotonin
                  syndrome)

               -  Alprazolam, diazepam (fluvoxamine modestly inhibits the metabolism of these
                  drugs): The patient could be enrolled in case of agreeing 25% dose reduction of
                  these medications.

          8. Already enrolled in another COVID-19 medication trial

          9. Medical comorbidities such as severe underlying lung disease (chronic obstructive
             pulmonary 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-stage
             renal disease requiring renal replacement therapy

         10. Immunocompromised (solid organ transplant, bone-marrow transplant, acquired immune
             deficiency syndrome, on biologics and/or high dose steroids [>20mg prednisone per
             day])

         11. Unable to provide informed consent (e.g., moderate-severe dementia diagnosis)

         12. Unable to perform the study procedures (self-assessment of oxygen saturation, blood
             pressure, and temperature using self-monitoring equipment)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? 1