Treatments for Patients with Resipiratory Infections/STRIVE (COVID-19)

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.

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:<ul>
<li>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)</li>
<li>Have blood draws</li>
<li>Keep in touch with the study team for about 60 days after you get the study drug</li></ul>

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 Enrollment