Purpose of this Study
We are doing this study to find out if an investigational drug called ensitrelvir (the study drug) is an effective option when it is given along with the current standard treatment for COVID-19.
Who Can Participate?
Eligibility
Adults ages 18+ who are hospitalized with COVID-19.
For more information about who can join this study, please contact the study team at mary.motta@duke.edu.
For more information about who can join this study, please contact the study team at mary.motta@duke.edu.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:
- Get a random assignment (like a coin flip) to receive either the study drug or placebo (sterile saline solution) through an infusion into a vein (IV)
- Have blood draws
- Keep in touch with the study team for about 60 days after you get the study drug
- Get a random assignment (like a coin flip) to receive either the study drug or placebo (sterile saline solution) through an infusion into a vein (IV)
- Have blood draws
- Keep in touch with the study team for about 60 days after you get the study drug
Locations
Duke University Hospital
Duke Regional Hospital
Duke Raleigh Hospital
Pickett Road Research
Visit Timing
Weekdays
Weekends
Evenings
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections
Principal Investigator
Peter
Smith
Protocol Number
PRO00112310
NCT ID
NCT05605093
Phase
III
Enrollment Status
OPEN TO ACCRUAL