A Phase 2, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults with COVID-19
Study for Critically ill Inpatients at Columbia University Irving Medical Center Who Want to Participate in the Convalescent Plasma Trial
Sponsor: Columbia University & Amazon Coronavirus Gift
Enrolling: Male and Female Patients
IRB Number: AAAS9924
U.S. Govt. ID: NCT04359810
Contact: COVID Convalescent Plasma Trial Critically-Ill Patients: / covid_odonnell_trial@cumc.columbia.edu
Additional Study Information: If you want to be a plasma donor please go to (https://recruit.cumc.columbia.edu/clinical_trial/1929). 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 or death in people with COVID-19. This research treatment is also known as convalescent plasma. If you choose to take part in this research study, designed by Dr. Max O'Donnell and Dr. W. Ian Lipkin, and your medical tests show that you are eligible, you will receive one dose of convalescent plasma through an infusion (via IV drip) along with standard treatment or standard treatment with infusion of control plasma. Two patients will receive convalescent plasma treatment for every one patient who receives the control plasma. The selection process is known as randomization. Randomization is like a coin toss; however, chances are twice as high that you will receive the convalescent plasma than the normal plasma. During this study we will ask you questions and collect information about your health, collect blood, conduct physical exams, perform a pregnancy test if you are a woman of child-bearing potential and perform mouth and throat swabs. We will also monitor the progression of your disease.
This study is closed
Max O'Donnell, MD, MPH
Do You Qualify?
Is the patient 18 years of age or older? Yes No
Did the patient test positive for SARS-CoV-2 with a confirmed PCR test within the past 14 days? Yes No
Does the patient have an oxygen saturation of less than or equal to 94%? Yes No
Is the patient currently hospitalized at Columbia University Irving Medical Center? Yes No
Does the patient have a history of IgA deficiency or transfusion reactions? Yes No
You may be eligible for this study

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For more information, please contact:
COVID Convalescent Plasma Trial Critically-Ill Patients