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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 - 100 Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

To help combat COVID-19, this clinical trial will evaluate if repurposed from other Food and Drug Administration (FDA) indication medications can make participants feel better faster and reduce death and hospitalization.

Details

Protocol number CED000000537

Eligibility

Inclusion:

  • Greater than 30 years old

  • Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening

  • Two or more current symptoms of acute infection for = 7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, the new loss of sense of taste or smell.

Exclusion:

  • Current or recent (within 10 days of screening) hospitalization for COVID-19.

  • Current use of study drug or study drug/device combination.

  • Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo.

  • Known contraindication(s) to the study drug including prohibited concomitant medications. Participation in the study will last about 3 months (90 days). All study visits can be remote (not in person). Participants will complete surveys online or by phone if they do not have access to a computer/tablet/smartphone or internet

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.