Status:
SUSPENDED
Fluvoxamine for Adults With Mild to Moderate COVID-19
Lead Sponsor:
Asan Medical Center
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Coronavirus Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This clinical trial aims to determine if fluvoxamine, a selective serotonin reuptake inhibitor with high affinity for the sigma-1 receptor, can be used in mild to moderate COVID-19 to prevent the prog...
Detailed Description
The investigators will randomize approximately 400 participants, age 18 and older, who have laboratory-confirmed, mild to moderate COVID-19 and are admitted to community treatment centers. All interac...
Eligibility Criteria
Inclusion
- Men and women age 18 and older
- 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
- 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
- Has laboratory-confirmed SARS-COV-2 infection (positive RT-PCR test) ≤ 3 days of randomization
- Able to provide informed consent
Exclusion
- Severe illness enough to require hospitalization or already meeting the study's primary endpoint for clinical deterioration
- Patients who cannot take oral medication
- Pregnancy or breastfeeding
- History of the psychiatric disorder including major depressive disorder
- Patients who are taking or took selective serotonin reuptake inhibitors, serotonin and noradrenaline reuptake inhibitor, or tricyclic anti-depressants within 2 weeks
- Patients who are taking an anti-epileptic drug
- 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.
- Already enrolled in another COVID-19 medication trial
- 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
- Immunocompromised (solid organ transplant, bone-marrow transplant, acquired immune deficiency syndrome, on biologics and/or high dose steroids \[\>20mg prednisone per day\])
- Unable to provide informed consent (e.g., moderate-severe dementia diagnosis)
- Unable to perform the study procedures (self-assessment of oxygen saturation, blood pressure, and temperature using self-monitoring equipment)
Key Trial Info
Start Date :
January 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04711863
Start Date
January 16 2021
End Date
July 31 2021
Last Update
April 19 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505