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Selective Serotonin Reuptake Inhibitor

Multiple Drug Therapy for COVID-19

Phase 3
Waitlist Available
Led By Carolyn Bramante, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known history of confirmed SARS-CoV-2 infection
GFR>45ml/min within 2 weeks for patients >75 years old, or with history of heart, kidney, or liver failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Study Summary

This trial is to understand if different treatments can prevent Covid-19 disease progression, improve viral load, and prevent long-covid syndrome.

Who is the study for?
Adults with a BMI >= 25kg/m2 (or >= 23kg/m2 for South Asian or Latinx backgrounds), who can swallow pills, have tested positive for COVID-19 within the last 3 days, and have no prior SARS-CoV-2 infection. Excluded are those on certain medications like SSRIs or warfarin, with unstable medical conditions, immune-compromised states, severe kidney disease, hospitalized patients, and those who've received specific COVID-19 treatments.Check my eligibility
What is being tested?
The trial is testing if Metformin alone or combined with Fluvoxamine or Ivermectin is better than a placebo in preventing COVID-19 progression in non-hospitalized adults. It also examines viral load reduction and long-term effects prevention compared to placebo.See study design
What are the potential side effects?
Possible side effects include digestive issues from Metformin; sleepiness, nausea from Fluvoxamine; dizziness from Ivermectin. There's also a risk of increased bleeding when mixed with blood thinners like warfarin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never tested positive for COVID-19.
Select...
My kidney function is good despite being over 75 or having heart, kidney, or liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count of Participants Who Died
Count of Participants With ED Visit, Hospitalization or Death
Count of Participants With Hospitalization or Death
+1 more
Secondary outcome measures
Clinical Progression Scale
Laboratory Outcome Subsidy
Albumins
+7 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm - Metformin and Ivermectin GroupExperimental Treatment2 Interventions
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin.
Group II: Treatment Arm - Metformin and Fluvoxamine GroupExperimental Treatment2 Interventions
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine.
Group III: Treatment Arm - Metformin Only GroupExperimental Treatment1 Intervention
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone.
Group IV: Treatment Arm - Ivermectin Only GroupExperimental Treatment1 Intervention
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone.
Group V: Treatment Arm - Fluvoxamine Only GroupExperimental Treatment1 Intervention
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone.
Group VI: Treatment Arm - Placebo GroupPlacebo Group1 Intervention
Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Fluvoxamine
2020
Completed Phase 4
~3259230
Ivermectin
2020
Completed Phase 4
~7180

Find a Location

Who is running the clinical trial?

Hennepin County Medical Center, MinneapolisOTHER
21 Previous Clinical Trials
10,997 Total Patients Enrolled
Northwestern UniversityOTHER
1,584 Previous Clinical Trials
916,442 Total Patients Enrolled
University of Colorado, DenverOTHER
1,731 Previous Clinical Trials
2,143,276 Total Patients Enrolled

Media Library

Fluvoxamine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04510194 — Phase 3
Coronavirus Research Study Groups: Treatment Arm - Placebo Group, Treatment Arm - Ivermectin Only Group, Treatment Arm - Fluvoxamine Only Group, Treatment Arm - Metformin Only Group, Treatment Arm - Metformin and Fluvoxamine Group, Treatment Arm - Metformin and Ivermectin Group
Coronavirus Clinical Trial 2023: Fluvoxamine Highlights & Side Effects. Trial Name: NCT04510194 — Phase 3
Fluvoxamine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04510194 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many sites where this experiment is taking place in the city?

"The 8 sites for this trial are situated in Golden, Minneapolis, Sylmar and other locations. To cut down on participant burden, it is best to select a location nearest to you."

Answered by AI

What are the goals that we hope to achieve by conducting this research?

"This study will assess the primary outcome of emergency department utilization over a 14-day period. Secondary outcomes include laboratory outcome subsidy - CRP (self-collected finger stick blood), change in CRP between baseline and follow-up, post-acute sequelae of SARS-CoV-2 infection (PASC) questionnaire, clinical progression scale, and percentage of participants who report PASC any symptoms."

Answered by AI

What is the most popular reason that people are prescribed Metformin?

"Metformin is most often used to treat strongyloidiasis, which is caused by the infection of Strongyloides stercoralis. However, it is also effective in treating a number of other conditions such as obsessive-compulsive disorder and gnathostomiasis."

Answered by AI

What is the desired sample size for this research project?

"This particular trial is no longer recruiting patients. The study was originally posted on January first 2021 but the most recent edit occurred on August fifth, 2022. There are presently 1859 trials actively enrolling patients with infections and 205 studies for Metformin that are still looking for research candidates."

Answered by AI

What are the potential risks associated with taking Metformin?

"Metformin has been given a safety score of three. This is based on the fact that it is a Phase 3 trial, which suggests that not only is there some evidence of its efficacy, but also that multiple rounds of testing have confirmed its safety."

Answered by AI

Does this test require that participants be adults?

"Based on the given information, this trial is for patients aged between 30-85. Out of the 379 clinical trials available for people under 18 and 1708 trials catered to those over 65, this one looks specifically at a middle-aged population."

Answered by AI

If I wanted to, could I join this research project?

"This study is admitting 1350 patients with infections aged 30 and 85. Most notable, candidates should meet the following criteria: Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. +PCR) within 3 days of randomization., No known history of confirmed SARS-CoV-2 infection, BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in South Asian or Latinx background., Willing and able to comply with study procedures (i.e. swallow pills),"

Answered by AI

Are there any vacancies in this trial for new participants?

"According to the information available on clinicaltrials.gov, this particular trial is no longer actively recruiting patients. The first posting was on January 1st, 2021 and the most recent edit was on August 5th, 2022. There are 2064 other trials that are still looking for patients."

Answered by AI

Has Metformin been looked into by other researchers in the past?

"There are currently 205 ongoing studies researching Metformin. 59 of those live studies are in Phase 3, meaning they have completed multiple rounds of data collection supporting efficacy and safety. While the many studies for Metformin are based in Nova Lima, MG, there are 2476 locations running clinical trials for this treatment worldwide."

Answered by AI
~311 spots leftby Apr 2025