STOP COVID 2 Canada

Study Design

STOP COVID 2 Canada is a placebo controlled randomized trial. This means that participants are randomized (like flipping a coin) to receive with the active drug fluvoxamine or a placebo (sugar pill or vitamin).

We are "repurposing" this drug for COVID-19 based on animal studies which show that it can reduce lung injury in experimental infections and on an earlier (smaller) human randomized controlled trial in COVID-19 (paper). In the STOP COVID trial, 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group had clinical worsening. This study STOP COVID 2 seeks to confirm those results are true in a larger and more representative sample of people living in the United States and Canada. Ours is a partner study with the STOP COVID 2 trial underway in the United States.

The key objectives are to determine if 15 days of fluvoxamine:

  1. Reduces the risk for developing severe shortness of breath, needing oxygen, and being hospitalized due to COVID-19.

  2. Reduces the risk for reduced functioning or long term symptoms due to COVID-19.

The study features CONTACTLESS ENROLLMENT whereby you register online and, if you are eligible, you receive all study materials via courier at your house. You measure your temperature and oxygen twice a day (with tools we give you) and then follow up via BRIEF internet surveys twice a day for 15 days. We also send you one more survey on day 90.

Drug Information

Fluvoxamine is an antidepressant medication which has commonly been used worldwide. It belongs to a class of drugs called Selective Serotonin Reuptake Inhibitors (SSRIs). It is approved in Canada for the treatment of depression and obsessive-compulsive disorder and has decades of safety data.

You will start the drug at 50mg for a test dose. If well tolerated, you will begin the next day at 100mg twice a day. This is below the maximum dose for this drug when normally used.

Participant Information

In general this study is open to patients who are not hospitalized who are:

  1. Age 30 and older;

  2. With proven SARS-CoV-2 positive (per lab, physician report, or self-report)

  3. Who are currently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnea (<=3/10 on visual analog score), chest pain, diarrhea, nausea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, nasal congestion.

  4. Who have 6 or fewer total days of symptoms

  5. And who have one of the following risk factors for clinical deterioration:

    • age≥40

    • self-identified racial/ethnic group African-Canadian, Hispanic, or Indigenous (including more than one race)

    • 1 or more of the following medical conditions which increase the risk for developing moderate-severe COVID illness:

      • Obesity

      • Hypertension

      • Diabetes

      • Heart disease (e.g. coronary artery disease, history of myocardial infarction, or heart failure)

      • Lung disease (e.g. asthma, COPD)

      • Immune disorder (e.g. rheumatoid arthritis, lupus)

There are also a number of exclusions meant to insure the safe use of fluvoxamine.

To fully determine your eligibility you would need to complete the screening questionnaire.

Our Team

PRINCIPAL INVESTIGATORS

Canadian Lead

Emily G. McDonald MD MSc FRCPC

Quebec Lead

Todd C. Lee MD MPH FIDSA

Ontario Lead - Women's College Hospital Site

Simone Vigod MD MSc FRCPC

QUEBEC RESEARCH TEAM

Soham Rej MD MSc, Collaborator and Study Psychiatrist

Sarah Elsayed, Study Manager

Kristen Moran, Research Assistant

Louisa Smyth, Research Assistant

Alek Lefebvre, Database Manager

Kathleen Normandin, Research Pharmacist

ONTARIO RESEARCH TEAM - Women's College Hospital Site

Payal Agarwal MD , Co-Inverstigator

Maria Michalowska, Site Coordinator

Aysha Butt, Research Assistant

Swati Atale, Research Assistant

FAQ

How can I know if I am eligible for the study?

Please consult the section participant information.

I need information about the study that is not included in the FAQ or in other sections on the website.

Please email us at stopcovid2@idtrials.com.

How do I take the medication?

You will take 50mg the day you receive your study kit. Afterwards, starting the next day, you will take 100mg twice a day.

What happens if I want to stop taking the medication?

You can decide to stop the study medication at any time during the study, for any reason. Please advise us on the next survey you will receive that you stopped the medication as it will help us analyze the final results. Please tell us if you are stopping because of side effects as we can suggest some ways to deal with them. If you agree, we will continue following you and sending you questionnaires until the end of the study. You may also decide to withdraw from the project at any time, without giving any reason, by informing the study doctor or a member of the research team.

Will I be compensated?

You will not receive financial compensation for participating in this research study. The research drug, fluvoxamine or placebo, plus a thermometer and finger oxygen saturation meter will be provided to you free of charge for the duration of this research study.

Do I stop taking the medication if I feel better?

No. Please continue your medication for its total duration (14 days) even if you feel your symptoms are improving.

What happens if I feel worse/my symptoms get worse?

If your symptoms of COVID-19 are worsening and you are concerned about your health, you need to let us know via phone or email (see contact information). As this is a distance study with online follow up, if you need urgent or emergent care, you will need to go through routine health procedures (i.e., contact your doctor, emergency department, call 911).

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 Health Canada-approved for the treatment of depression & OCD. Health Canada has no objection to the use of fluvoxamine in this study looking to determine its usefulness in treating COVID-19. Using 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 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 2 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 the study open to volunteers anywhere in Canada?

At this time, STOP COVID 2 Trial is open to volunteers residing anywhere in Quebec.

In Ontario, the trial is open to those who are part of the Women’s College Hospital CovidCare@home program ( https://covidcareathome.ca/). We are working to make it available across the country.

Will I experience any side effects from taking fluvoxamine?

There are NO common (>10% risk) side effects from taking fluvoxamine.

Uncommon side effects of fluvoxamine (1-10%) include:

  • 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

  • Temporary, reversible 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, rash or itchy skin, mania (elevated mood), seizures, abnormal liver function, light sensitivity— contact your doctor or STOP COVID 2 trial staff immediately.

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.