Contactless Clinical Trial for COVID-19 Treatment

Researchers at Washington University School of Medicine are testing a medicine for patients who have mild symptoms in the early course of COVID-19 treatment.

What is the purpose of this study?

STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning volunteers may participate without leaving their home. Medication and study supplies are delivered by a courier or shipped overnight. We hope our study will demonstrate whether or not taking a medication, fluvoxamine, will help to prevent worsening of symptoms and prevent hospitalization.

Am I eligible to participate?

You may be eligible if you:

  • Are age 30 or older
  • Recently tested positive for COVID-19
  • Have current symptoms of COVID-19 that started within the past 6 days
  •  Have at least one of the following risk factors for developing serious COVID-19: age 40 or older, African-American, Hispanic/Latino, Native American, obesity, hypertension, or immune disease
  • Have not been vaccinated against COVID-19

You are not eligible if:

  • Your symptoms of COVID-19 started more than 6 days ago
  • You are currently hospitalized
  • You have received an infusion of monoclonal antibodies or convalescent plasma
  • You have received a vaccine for the COVID-19 virus
  • You are unable to take the study medication, fluvoxamine
  • You are taking one or more of the following medications:  sertraline, donepezil, coumadin (warfarin), plavix (clopidogrel)

    What will happen if I choose to participate?

    If you are eligible and choose to participate:

    • You may be asked to take a safe dose of fluvoxamine or placebo for approximately 15 days.
    • You may be asked to log symptoms twice daily.
    • You may be asked to complete additional surveys approximately 3 months after you begin taking the study medication.
    • Your participation may last approximately 3 month.

    You can learn more about the study from our recent segment on 60 Minutes:

    60 Minutes: Finding a possible early treatment for COVID-19 in a 40-year-old antidepressant

    Frequently Asked Questions

    Fluvoxamine is used to treat OCD, why is this medicine being used to treat COVID-19 symptoms?

    Fluvoxamine may benefit COVID-19 patients by slowing the progression of symptoms. It is safe, inexpensive, and FDA-approved.  Using FDA-approved medicines for a new purpose, drug repurposing, is used to test new treatments more quickly compared to developing new medicines.

    I am certain I had/have COVID-19 but was never tested, am I eligible to participate?

    For the purposes of this trial, only individuals who actually tested positive for COVID-19 may be eligible.

    Will I be compensated for being in the study?

    You will be paid up to $50 if you finish the whole study.

    Will the study team be in touch with my physician during the study?

    The study team may notify your primary care provider of your participation. STOP COVID-19 is a  clinical trial and will not replace standard or emergency medical care.

    What does it mean to be a randomized controlled trial or RCT?

    STOP COVID Trial is a randomized controlled trial. This type of study compares the effects of one treatment, safe dosage of fluvoxamine, to a placebo. A placebo is a substance that has no therapeutic effect.

    You and the other study participants will have your treatment assigned randomly, like flipping a coin or rolling the dice. You will not get to choose which treatment to try. Your treatment assignment will also be kept a secret from you and the members of the research team who are evaluating you. This is to keep the expectations about the treatment from influencing the measurement of its effects.

    This study design is necessary to rigorously test a new treatment.

    Is this study open to volunteers anywhere in the U.S.?

    YES! The STOP COVID Trial is only open to volunteers residing in in the United States.

    How do I get tested for COVID-19?

    If you are experiencing symptoms such as a fever, cough, or difficulty breathing and you believe you may have been exposed, start by calling your primary care physician or family physician.

    Additional information is available online through your local health department.

    For residents of Missouri or Illinois, more information can be found at the links below:

    The Missouri Department of Health & Senior Services COVID-19 Outbreak Page

    The State of Illinois Coronavirus Response Page

    Will I experience any side effects from taking Fluvoxamine?

    Uncommon Side Effects of FLUVOXAMINE (1-10%)

    • Dizziness
    • Weight loss or loss of appetite
    • Agitation, nervousness, or anxiety
    • Yawning
    • Trouble sleeping or excessive sleepiness
    • Tremor
    • Headache
    • Palpitations (feeling your heart beating)
    • High heart rate
    • Diarrhea or constipation
    • Sweating
    • Weakness or feeling of malaise
    • Dry mouth
    • Nausea
    • Vomiting
    • Sexual dysfunction (delayed orgasm or reduced libido)

      However, if you experience any of the following rare side effects (<1%) — painful joints, hallucinations, confusion, drop in blood pressure while standing, edema (build up of fluid), rash or itchy skin, main (elevated mood), seizures, abnormal liver function,  light sensitivity— contact your doctor or STOP COVID Trial staff immediately.

      How do I receive the medication in a contactless study?

      The study medication and self-monitoring equipment such as an oxygen saturation monitor (which goes on your fingertip and measures how much oxygen is in your blood), blood pressure monitor, and thermometer will be delivered by a courier or overnight shipping service.

      What are the benefits of participating in this study?

      You may or may not benefit from being in this study. However, we hope that, in the future, other people might benefit from this study because the results will provide more knowledge on the effectiveness of fluvoxamine in the treatment for COVID-19.

      For more information about Washington University in St. Louis’s response to the COVID -19 Pandemic visit