Fluvoxamine for Adults With Mild to Moderate COVID-19

NCT04711863 | Suspended Phase 2

• 1 other identifier: S2020-3124-0001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 progression to severe COVID-19. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder and has a potential for immune modulation as a sigma-1 receptor agonist. The investigational use of fluvoxamine for the treatment of COVID-19 is approved by the South Korean Ministry of Food and Drug Safety. This study is performed fully-remotely at COVID-19 community treatment centers, temporary facilities in Seoul, Korea, to accommodate and monitor asymptomatic to moderately symptomatic case-patients who do not require hospital admission.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; Coronavirus Infection; Mild to Moderate COVID-19

Keywords

Fluvoxamine; mild to moderate COVID-19; SARS-CoV-2 treatment

Outcome Measures

Primary Outcomes (1)

• Clinical deterioration

  Defined as one of the followings: 1) Decrease in O2 saturation (SpO2 \<94%) on room air, 2) Supplemental oxygen requirement in order to keep O2 saturation ≥94%, 3) Aggravation of pneumonia with dyspnea: clinically devastating condition judged by clinician plus increased infiltration of chest X-ray or minute respiratory rate over 25. 4) WHO Clinical Progression Scale ≥5 including intubation and death)

  up to 10 days

Secondary Outcomes (4)

• Time to clinical deterioration

  up to 10 days

• Rate of each component of primary outcome including WHO Clinical Progression Scale

  up to 10 days

• Rate of transfer to general hospital regardless of any reasons

  up to 10 days

• Evaluation of adverse events

  up to 10 days

Study Arms (2)

Fluvoxamine

EXPERIMENTAL

Start fluvoxamine 50 mg once, then 100 mg twice daily until discharge from community treatment center or for approximately 10 days. The maintenance dose may be reduced for tolerability reasons.

Drug: Fluvoxamine

Placebo

PLACEBO COMPARATOR

Start ursodeoxycholate (UDCA) 100 mg once, then 100 mg twice daily until discharge from community treatment center or for approximately 10 days. The maintenance dose may be reduced for tolerability reasons.

Drug: Placebo

Interventions

Fluvoxamine DRUG

Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days

Fluvoxamine

Placebo DRUG

Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Seo H, Kim H, Bae S, Park S, Chung H, Sung HS, Jung J, Kim MJ, Kim SH, Lee SO, Choi SH, Kim YS, Son KY, Chong YP. Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial. Infect Chemother. 2022 Mar;54(1):102-113. doi: 10.3947/ic.2021.0142.

  PMID: 35384422 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Yong Pil Chong, M.D., Ph.D.

  Asan Medical Center, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 16, 2021
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)