ABOUT THIS STUDY


In this research study we will compare the side effects and benefits of zotatifin compared to a placebo to see if it works better or is safer than not taking anything at all. The placebo is a substance that looks like zotatifin but has no active antiviral medication. In this study we will also see how the body processes zotatifin.

Zotatifin is an "investigational" antiviral treatment because it has not been approved by any government agency, including the U.S. Food and Drug Administration (FDA). It has not been given to people for the treatment of COVID-19 prior to this study but has been given to people in ongoing research studies of other diseases.

Qualified participants in this study will be randomly assigned to receive either zotatifin or placebo. Participants have a 75% (3 in 4) chance of receiving zotatifin and a 25% (1 in 4) chance of receiving placebo.

Participation in this research study will involve 4 study visits to the study center, 3 study visits which will be conducted by a study staff member visiting the participant at home, and 1 follow-up telephone call 30 days after the last dose of zotatifin or placebo. The length of time for study participation will be approximately 5 to 6 weeks.

Approximately 36 people are expected to participate in this research study at about 4 to 5 study sites in the United States.





What to Expect

  • After talking with potential participants, the study staff will give a detailed explanation of this study and its potential risks and benefits to those potential participants who the staff believes may qualify to participate.
  • Those potential participants wishing to proceed will be asked to sign a written informed consent form. The study doctor and staff will review the participant's medical history and conduct tests to determine whether the participant satisfies all study requirements.
  • Once fully qualified, participants will be treated as described above.
  • Participants will be given a study diary to record symptoms.

Participation Costs

All study-related medical examinations and study treatment is provided to qualified participants at no cost. Insurance is not required for participation.