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Multiple Drug Therapy for COVID-19
Study Summary
This trial is to understand if different treatments can prevent Covid-19 disease progression, improve viral load, and prevent long-covid syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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Who is running the clinical trial?
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- You weigh more than what is considered healthy for your height, or if you're of South Asian or Latinx background, you weigh more than a slightly lower healthy weight for your height.I don't have any health conditions or medications that would make it unsafe for me to join.Participants taking certain medications for depression, anxiety, and other conditions may be excluded from the study unless their doses are very low and unlikely to cause problems when combined with the study drug fluvoxamine. These medications include escitalopram, amitriptyline, alprazolam, diazepam, theophylline, clozapine, olanzapine, caffeine, nicotine, melatonin, warfarin, NSAIDs, aspirin, phenytoin, clopidogrel, and St John's wort. Additional treatments for COVID-19 may also be excluded based on a panel's decision.I have a weakened immune system due to a condition like a transplant or AIDS, or I am on high dose steroids.I have severe liver problems.I have severe kidney disease or heart failure that affects my health significantly.I have received an FDA-approved treatment for COVID-19.I am currently hospitalized.My symptoms started more than a week ago.You have a problem with drinking too much alcohol.I have not had typhoid, BCG, or cholera vaccines recently.I am currently infected with loa loa or onchocerciasis.I am not taking any of the listed medications.You have tested positive for active COVID-19 infection in the past 3 days.I have never tested positive for COVID-19.My kidney function is good despite being over 75 or having heart, kidney, or liver issues.You had an allergic reaction to metformin, fluvoxamine, or ivermectin before.I have bipolar disorder or am on medication for it, but my risk for mania is low.
- Group 1: Treatment Arm - Placebo Group
- Group 2: Treatment Arm - Ivermectin Only Group
- Group 3: Treatment Arm - Fluvoxamine Only Group
- Group 4: Treatment Arm - Metformin Only Group
- Group 5: Treatment Arm - Metformin and Fluvoxamine Group
- Group 6: Treatment Arm - Metformin and Ivermectin Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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),"
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."
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."
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