• A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Vaccine

    July 23, 2021 Alexis Sexton

    Right now there is no medicine proven to treat COVID-19 in people who are not sick enough to be hospitalized. Researchers will be testing different investigational medicines that they believe are most likely to help people with COVID-19.

    They want to see if these investigational medicines:

    • Are safe for those who need them
    • Can help people get better faster
    • Can get rid of the virus
    • Can help keep oxygen levels up
    • Can keep people from getting sicker
    • Can prevent people from having to go to the hospital

    The whole study lasts about 6 months (24 weeks).

    During the study you would have in-person visits with tests to check on your health. Most of these visits happen during the first month of the study.

    You would also have phone calls or videos chats with the researcher from your home.

    The study team will give you a diary to keep track of your temperature each evening and any symptoms you have. You’ll be asked to fill out this diary for the first 28 days.

    If the study is right for you, you will have your first visit, or entry visit, to meet with a researcher for tests and to be placed in a treatment group.

    Each study medicine will be compared to a placebo. A placebo looks like the real drug but doesn’t have any actual medicine in it. This gives researchers something to compare the study medicine to. You would not know if you are receiving the study medicine or placebo until the end of the study. If a standard treatment for COVID-19 is found during the study, that treatment will be used instead of placebo. Different medicines may be tested during the study at the same time. One type of investigational medicine you might receive is called a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the lab and help your body attack invaders, such as viruses, to keep them from entering your cells. Once you are placed in a treatment group, you will receive more information on that investigational medicine being tested, including any possible side effects.


    To learn more about this study click here.

  • A5401: ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies

    July 21, 2020 Alexis Sexton

    Study Description:

    A master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.

    Why is this study being done?

    To rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.

    Who can join?

    • Ambulatory Adult (18 years or older)
    • Active SARS-CoV-2 infection <7 days prior to Entry
    • At least one typical COVID-19 symptom for <10 days prior to Entry, plus one the following symptoms present within 48 hours of entry:

    –Fever or feeling feverish, cough, shortness of breath at rest or with activity, sore throat, body or muscle pain, fatigue, headache, chills

    • Tailored per study agent requirements

    Duration of study: 28 days of intensive follow-up, followed by limited follow-up through 24 weeks.


    To find more information click here and to see our press release relating to this study click here.