A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment/Prevention of COVID-19
Sponsor: |
Amazon |
Enrolling: |
Male and Female Patients |
Study Length: |
90 Days |
Clinic Visits: |
9 |
IRB Number: |
AAAT0052 |
U.S. Govt. ID: |
NCT04390503 |
Contact: |
Jessica Justman MD: (347) 590-7280 / cpccstudy@cumc.columbia.edu |
The purpose of this research study is to find out whether antibodies collected from the blood of people, who have been infected with the virus SARS-CoV-2 and recovered from COVID-19, can be used to reduce the risk of severe disease in people who have been recently exposed to COVID-19 or have confirmed COVID-19 infection with no or mild symptoms. This research treatment is also known as convalescent plasma."If you chose to take part in this research study, and your medical tests show that you are eligible, you will either receive a one-time infusion of convalescent plasma from people recovering from COVID-19 or a placebo. Your study group (plasma or placebo) will be chosen for you randomly, like flipping a coin. During this study we will ask you questions and collect information about your health, collect blood, conduct physical exams, laboratory tests and any symptoms or problems participants may experience during the study. There will be a total of 7 visits in- person and 2 phone visits over the course of 90 days.
This study is closed
Investigator
Jessica Justman, MD
Are you age 18 or older? |
Yes |
No |
Are you a close contact of a person with COVID-19 OR did you have a positive PCR test for SARS-CoV-2 within the past 7 days? |
Yes |
No |
Do you have no symptoms or no more than 5 days of mild symptoms? |
Yes |
No |
Are you a resident of a long term or skilled nursing facility? |
Yes |
No |