What is the purpose of the Propel study?
The purpose of the Propel study is to see how safe and effective zotatifin is at helping prevent people with mild to moderate COVID-19 from advancing to severe COVID-19.
Who can participate in the Propel study?
You must meet several basic study requirements* to join the study:
- 18 years of age or older, but younger than 65
- Positive test for SARS-CoV-2 (the coronavirus that causes COVID-19)
- At least 2 symptoms of COVID-19 that began no more than 5 days before starting the study drug
- Examples of symptoms include fever or chills, cough, shortness of breath, fatigue, and headache, among others
- Not hospitalized for COVID-19
What will happen during the study?
Study participation lasts about 40 days. You can expect the following:
Review & sign the ICF
The Informed Consent Form (ICF) explains the study in more detail. You must review and sign it before moving forward in the study and having any study procedures.
You will have different study procedures during the Screening period to confirm that you can join the study.
Receive study drug
If you qualify to participate, you will be randomly assigned to receive either zotatifin or placebo (which has no active ingredients). You will have a 25% chance of getting placebo and a 75% chance of getting zotatifin. At the study clinic, you will receive study drug as an intravenous (IV) infusion that lasts about 1 hour at the study clinic on study Days 1 and 8.
Have home health visits
A healthcare professional will visit you at your home to complete different study procedures that monitor your health and the safety and effectiveness of the study drug. You will have to return to the study clinic on study Day 15.
Monitor your symptoms
Every day during your study participation, you are required to record any symptoms in a study diary. You also will need to take daily saliva samples and nose swabs. The study doctor/staff will provide instructions on how to do these collections.