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Fluvoxamine for Adults With Mild to Moderate COVID-19

Primary Purpose

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

Status

Suspended

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Fluvoxamine

Placebo

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 focused on measuring Fluvoxamine, mild to moderate COVID-19, SARS-CoV-2 treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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)

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluvoxamine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to clinical deterioration

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

Rate of transfer to general hospital regardless of any reasons

Percentage of patients who are transferred to a hospital to manage various conditions

Evaluation of adverse events

Rate of adverse events

Full Information

NCT ID

NCT04711863

First Posted

January 13, 2021

Last Updated

April 14, 2021

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04711863

Brief Title

Fluvoxamine for Adults With Mild to Moderate COVID-19

Official Title

Fluvoxamine for Adults With Mild to Moderate COVID-19: A Single-blind, Randomized, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Suspended

Why Stopped

Closure of main community treatment center

Study Start Date

January 16, 2021 (Actual)

Primary Completion Date

May 31, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

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 interactions for this study will be conducted remotely by videoconferencing, mobile application, or phone. Screening Phase: All patients admitted to community treatment centers receive self-monitoring equipment, including an oxygen saturation monitor, blood pressure monitor, and thermometer. All participants will first complete a pre-screen to see if they may be eligible for the study. Once a participant is confirmed eligible and consented, the study team will deliver study drugs to each participant room. RCT Phase: Participants will be randomly assigned (1:1) to take either fluvoxamine or placebo (ursodeoxycholate). This phase of the study will last until discharge from community treatment centers (usually 10 days) and is single-blinded as the participants will not know which treatment they receive. Participants will take up to 100 mg of fluvoxamine or placebo by mouth twice a day for a daily total of 200 mg. Participants will continue this dose until discharge from community treatment centers (for approximately 10 days). The dose may be adjusted depending on tolerability. Participants will complete short 10 minute assessments twice a day to report the results of self-monitoring (oxygen saturation, blood pressure, and temperature), COVID-19 symptoms, and any adverse events using mobile application or phone. Follow-up Phase: The study team will follow participants for approximately 30 days after the end of the randomized phase (after discharge from community treatment centers) using phone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluvoxamine

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fluvoxamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical deterioration

Description

Time Frame

up to 10 days

Secondary Outcome Measure Information:

Title

Time to clinical deterioration

Time Frame

up to 10 days

Title

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

Time Frame

up to 10 days

Title

Rate of transfer to general hospital regardless of any reasons

Description

Percentage of patients who are transferred to a hospital to manage various conditions

Time Frame

up to 10 days

Title

Evaluation of adverse events

Description

Rate of adverse events

Time Frame

up to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Pil Chong, M.D., Ph.D.

Organizational Affiliation

Asan Medical Center, Seoul, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35384422

Citation

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. Erratum In: Infect Chemother. 2022 Jun;54(2):391.

Results Reference

derived

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Fluvoxamine for Adults With Mild to Moderate COVID-19

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