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Fluvoxamine for Adults With Mild to Moderate COVID-19

NCT04711863 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-04-19

No results posted yet for this study

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

Interventions

DRUG

Fluvoxamine

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yong Pil Chong, M.D., Ph.D. · Asan Medical Center, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-16
Primary Completion
2021-05-31
Completion
2021-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711863 on ClinicalTrials.gov