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(904) 244-0411

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

  • Status
    Accepting Candidates
  • Age
    30 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

In general, what is the purpose of the research, how long will you be involved? You are being invited to participate in ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications. About 15,000 participants from around 280 sites across the United States will be involved. The study is funded by The National Center for Advancing Translational Sciences (NCATS), a division of The National Institutes of Health (NIH). Duke Clinical Research Institute (DCRI) is the clinical coordinating center and Vanderbilt University Medical Center (VUMC) is the data coordinating center for this study. Please consider the following information in making your decision. You are being asked to participate in this study because you have been diagnosed with the SARS-CoV-2 virus, you currently have some symptoms of COVID-19, the disease caused by the virus, and you are at least 30 years old. As part of this study, you will be given either a study medication or a placebo to see what types of effects the study medication or the placebo may have on your ability to get better and recover from the infection. You may benefit, but there is no guarantee. Others may benefit from the information learned.

Details

Protocol number 20211467

Eligibility

Inclusion:

You are at least 30 years old. You have the results of a SARS-CoV-2 test (COVID-19test) dated within the last 10 days for infection or reinfection.

You have at least two of the following symptoms of acute infection for less than or equal to 7 days: fatigue, dyspnea (shortness of breath), fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell.

Exclusion:

Current or recent (within 10 days of screening) hospitalization for COVID-19 infection. Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI) Current or recent use (within the last 14 days) of study drug or study drug/device combination. Previously enrolled in the ACTIV-6 trial.

Lead researcher

  • Carmen Isache, MD
    Internal Medicine Physician (Internist), Infectious Disease Physician

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.