Study for COVID-19 Positive Patients Recovering at Home
Protocol: STUDY00005142
Full Title
Adaptive Platform Treatment Trial for Outpatients with COVID-19; Protocol A5401
Description
This study enrolls people who have tested positive for COVID-19 but are not hospitalized. The purpose of this study is to learn about how well the study medications improve the symptoms of COVID-19 and keep people from getting so sick that they have to be hospitalized. We will also want to learn how well people tolerate the study medicines.

You may need to go to the study site from time to time and you may do home visits. Visits are frequent in the first couple of weeks, then space out. While you're in the study, you will:
-Record information into a daily diary.
-Give blood samples.
-Complete self-collected nasal swab samples.
-Have deep nasal swabs and saliva collected by a study staff person.

For more information, please visit: https://www.riseabovecovid.org/en/ Study takes place at Kaleida Health Facilities and ECMC Hospital in Western New York.

Technical Description

1.1.1 Phases II and III: To evaluate safety of the investigational agent.1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28.1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with undetectable nasopharyngeal (NP) SARS-CoV-2 RNA at study days 3, 7, 14, and 28.1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of either hospitalization or death through study day 28. Hospitalization is defined as ???24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.

Keyword: COVID-19
Compensation: Yes
?
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18+.
Have tested positive for COVID-19.
Not currently hospitalized.
Age Group: Adults
Principal Investigator: BRIAN CLEMENCY
Contact(s)
Lucy Connery
lucyconn@buffalo.edu
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.