Severe Acute Respiratory Syndrome Coronavirus 2Phase 2NCT04711863
Fluvoxamine for Adults With Mild to Moderate COVID-19
A Phase 2 study testing Fluvoxamine in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Coronavirus Infection, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus Infection, Mild to Moderate COVID-19
- What is being tested?
- Fluvoxamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2021to 31 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluvoxamine for Adults With Mild to Moderate COVID-19: A Single-blind, Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus Infection, Mild to Moderate COVID-19
- Being tested
- Fluvoxamine, Placebo
- Keywords
- Fluvoxamine, mild to moderate COVID-19, SARS-CoV-2 treatment
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvoxamineDrug
Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days
PlaceboDrug
Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 10 days
Secondary outcomes (4)
Time to clinical deterioration
Measured: up to 10 days
Rate of each component of primary outcome including WHO Clinical Progression Scale
Measured: up to 10 days
Rate of transfer to general hospital regardless of any reasons
Percentage of patients who are transferred to a hospital to manage various conditions
Measured: up to 10 days
Evaluation of adverse events
Rate of adverse events
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start16 Jan 2021
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: Closure of main community treatment center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Pil Chong, MD, Asan Medical Center
- Investigators
- Yong Pil Chong, M.D., Ph.D., Principal investigator, Asan Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711863
- Sponsor's protocol ID
- S2020-3124-0001
- Status last verified
- Apr 2021
- First submitted
- 13 Jan 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35384422
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluvoxamine for Adults With Mild to Moderate COVID-19: A Single-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04711863
- Acronym / sponsor ID
- S2020-3124-0001
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Closure of main community treatment center
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluvoxamine | Experimental | Drug: FluvoxamineStart 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. |
| Placebo | Placebo comparator | Drug: PlaceboStart 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Has laboratory-confirmed SARS-COV-2 infection (positive RT-PCR test) ≤ 3 days of randomization
- Able to provide informed consent
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluvoxamineUp to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days | Drug | Fluvoxamine |
| PlaceboUp to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days | Drug | Placebo |
Primary outcome
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)
4 secondary outcomes
Time to clinical deterioration
Time frame: up to 10 days
Rate of each component of primary outcome including WHO Clinical Progression Scale
Time frame: up to 10 days
Rate of transfer to general hospital regardless of any reasons
Time frame: up to 10 days
Evaluation of adverse events
Time frame: up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 35384422Seo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Pil Chong, M.D., Ph.D. principal investigator
Asan Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluvoxamine in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Coronavirus Infection, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical deterioration (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.