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(904) 244-0411

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of Asapiprant in Hospitalized Adults With COVID-19

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

Individuals diagnosed with COVID-19 are being asked to take part in a research study of an investigational drug called Asapiprant (BGE 175).

This drug is being tested for the treatment of COVID-19. “Investigational” means that the drug is currently being tested and has not been approved by the FDA.

During this study, you may be provided with a bottle of study drug or a bottle containing tablets that look like the study drug (Placebo) but may not contain any drug. Both you and your doctor will not know whether or not you are taking an active drug or a placebo drug.

You will be instructed by your study doctor or staff about how many tablets to take from the bottle. If a new bottle is needed, it will be provided to you before your current bottle runs out of study drug. After you completely use a bottle, do not throw it away. Used bottles must be returned to the clinic so that the study team can account for how much study drug was used.

During this study, participants will take study drug doses and complete study visits while in the hospital. If participants are discharged from the hospital 14 days after starting the study drug, participants will continue study visits, which may take place at the study clinic or at the participants home depending on how participants plan these visits with the study doctor. If participants have been discharged to go home, participants will need to visit the clinic 14 days after taking the last tablet of the study drug. In addition, if participants are discharged from the hospital 14 days after starting to take the study drug, participants will be provided with a "Dosing Diary," which participants will need to complete in order to track participants dosing. The participant's doctor and/or a member of the study staff will provide participants with the instructions on how to complete the Dosing Diary.

The Dosing Diary, along with the used/unused bottles of the study drug, will need to be brought back for participants' follow-up visits to the clinic to complete treatment with the study drug.

Details

Protocol number 20210252

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.