While there is hope that the worst of the pandemic is behind us, hundreds of thousands of cases of COVID-19 are still reported daily around the globe. That is why it’s so important to continue to advance not only prevention, but also the treatment of COVID-19.

This potential oral treatment study is underway for adults with COVID-19 who are at increased risk of worsening symptoms due to underlying medical conditions.

Who may participate

Joining a clinical trial is an important and personal decision. Thank you for considering this study.

This study may be an option for you if you meet all the requirements below:

  • You tested positive for COVID-19 in the last 5 days
  • You recently developed symptom(s)
  • You have one or more of the following symptoms:
    • Feeling Feverish
    • Cough
    • Shortness of Breath or Difficulty Breathing
    • Sore Throat
    • Body Pain or Muscle Pain/Aches
    • Fatigue (Tiredness)
    • Headache
    • Chills
    • Stuffy or Runny Nose 
    • Nausea or Vomiting
    • Diarrhea
    • Temperature Greater Than 38˚C/100.4˚F

There are other requirements for participation in the study. The study doctor will explain these to you.

Condition
COVID-19

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age
18+ years

The age a person must be to participate in a clinical trial.

Sex
Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

The study involves comparing an investigational (study) drug against a placebo. We learn about the effectiveness and safety of the study drug by comparing the experiences of the participants who receive the study drug to those who receive the placebo.  Half of all participants will receive the study drug, and the other half will receive the placebo.  In addition to the study drug or placebo, you will receive treatment for COVID-19 that your doctor recommends.

Your participation in the study will last about 6 months. You will have in-person or remote visits by telemedicine (over the telephone or computer). You will be asked to track any changes in your health in an electronic diary (e-diary).

Length of study treatment
5 days (10 total doses)

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits
10 visits in-person or remote by telemedicine (over the phone or computer)

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

About risk factors and participation

Each clinical study has its own guidelines for who can participate, called eligibility criteria. In this study, you must have at least one risk factor or medical condition to be eligible to participate:   

Some of the risk factors include being,

  • 60 years of age or older
  • Overweight with a Body Mass Index (BMI) greater than 25
  • A current smoker

Some of the medical conditions include,

  • Chronic Kidney Disease (CKD)
  • Type 1 or Type 2 Diabetes
  • Immunosuppressive Disease
  • Heart Disease
  • Chronic Lung Disease
  • Active cancer, other than skin cancer

Only the research study staff can determine if you qualify to enroll in the study.

Frequently asked questions

How often will I have to attend study appointments?

You will be asked to attend 10 study visits over the course of 6 months. Some of these visits may be by telemedicine (over the phone or computer).

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What if I change my mind about participating?

Your participation in this study is completely optional. You can choose to stop participating in the study at any time, for any reason.

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Can I still participate if I do not have an underlying medical condition?

This study requires participants to have at least one of the listed risk factors or medical conditions. If you would like to participate in a COVID-19 clinical trial, please visit COVIDPillStudy.com to see if you may qualify for another clinical trial. 

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What are the possible side effects? What if I have a negative reaction to the study treatment?

Your study doctor will discuss all the possible risks and benefits of participating in this study with you before you choose to enroll. You can choose to no longer participate in the study at any time.

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