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Fluvoxamine for Adults With Mild to Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04711863
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Yong Pil Chong, MD, Asan Medical Center

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.


Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Coronavirus Infection Mild to Moderate COVID-19 Drug: Fluvoxamine Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fluvoxamine for Adults With Mild to Moderate COVID-19: A Single-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : January 16, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: Fluvoxamine
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
Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days

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




Primary Outcome Measures :
  1. Clinical deterioration [ Time Frame: up to 10 days ]
    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 :
  1. Time to clinical deterioration [ Time Frame: up to 10 days ]
  2. Rate of each component of primary outcome including WHO Clinical Progression Scale [ Time Frame: up to 10 days ]
  3. Rate of transfer to general hospital regardless of any reasons [ Time Frame: up to 10 days ]
    Percentage of patients who are transferred to a hospital to manage various conditions

  4. Evaluation of adverse events [ Time Frame: up to 10 days ]
    Rate of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711863


Contacts
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Contact: Yong Pil Chong, M.D., Ph.D. +82230103306 drchong@amc.seoul.kr
Contact: Seongman Bae, M.D. +821025024925 songman.b@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Sun Hwa Park    821051751534    Sunhwa1534@naver.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Yong Pil Chong, M.D., Ph.D. Asan Medical Center, Seoul, Korea
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Responsible Party: Yong Pil Chong, MD, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04711863    
Other Study ID Numbers: S2020-3124-0001
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yong Pil Chong, MD, Asan Medical Center:
Fluvoxamine
mild to moderate COVID-19
SARS-CoV-2 treatment
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Fluvoxamine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors