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Clinical Trial Details

Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of Asapiprant in Hospitalized Adults With COVID-19
Study Description

Individuals diagnosed with COVID-19 are being asked to take part in a research study of an investigational drug called Asapiprant (BGE 175).

This drug is being tested for the treatment of COVID-19. “Investigational” means that the drug is currently being tested and has not been approved by the FDA.

During this study, you may be provided with a bottle of study drug or a bottle containing tablets that look like the study drug (Placebo) but may not contain any drug. Both you and your doctor will not know whether or not you are taking an active drug or a placebo drug.

You will be instructed by your study doctor or staff about how many tablets to take from the bottle. If a new bottle is needed, it will be provided to you before your current bottle runs out of study drug. After you completely use a bottle, do not throw it away. Used bottles must be returned to the clinic so that the study team can account for how much study drug was used.

During this study, participants will take study drug doses and complete study visits while in the hospital. If participants are discharged from the hospital 14 days after starting the study drug, participants will continue study visits, which may take place at the study clinic or at the participants home depending on how participants plan these visits with the study doctor. If participants have been discharged to go home, participants will need to visit the clinic 14 days after taking the last tablet of the study drug. In addition, if participants are discharged from the hospital 14 days after starting to take the study drug, participants will be provided with a "Dosing Diary," which participants will need to complete in order to track participants dosing. The participant's doctor and/or a member of the study staff will provide participants with the instructions on how to complete the Dosing Diary.

The Dosing Diary, along with the used/unused bottles of the study drug, will need to be brought back for participants' follow-up visits to the clinic to complete treatment with the study drug.

Open Enrollment
Contact Name: Morgan Howard
Contact Phone: (904) 244-9633
Contact Email: morgan.howard@jax.ufl.edu
Investigators

Principal Investigator
Carmen L. Isache, M.D.
Medicine