Convalescent Plasma to Limit Coronavirus Associated Complications in Hospitalized Patients, A Randomized, Double-Blinded, Placebo-Controlled Trial
COVID-19 convalescent plasma (CCP) is a blood product containing anti–SARS-CoV-2 antibodies and is obtained from people who have recovered from COVID-19. This product is rapidly available from people who have recovered and can be administered to patients recently diagnosed with COVID-19. The hope is that it will provide immediate passive immunity and help patients recover more quickly from this devastating disease. However, there are no randomized clinical trial data demonstrating a beneficial effect of CCP administration to patients hospitalized with COVID-19.
The National Institutes of Health’s National Center for Advancing Translational Sciences has funded the CONTAIN COVID-19 Trial to answer this important clinical question. This is a multicenter collaboration led by principal investigators (PIs) Mila B. Ortigoza, MD, PhD, from NYU Grossman School of Medicine/NYU Langone Health, and Liise-anne Pirofski, MD, and Hyunah Yoon, MD, from Albert Einstein College of Medicine/Montefiore Medical Center. The trial was launched on April 17, 2020, at NYU Langone and Albert Einstein College of Medicine/Montefiore Medical Center during the peak of the COVID-19 pandemic. Since then, the trial has expanded to multiple collaborating centers.
Patients must meet the following criteria to be included in the study:
- at least 18 years of age
- hospitalized with laboratory-confirmed COVID-19
- one or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation less than or equal to 94 percent, abnormal CXR/CT imaging
- hospitalized for 72 hours or less, or within 7 days from first signs of illness
- on supplemental oxygen, noninvasive ventilation, or high-flow oxygen
Patients may be participating in other randomized controlled trials of pharmaceuticals for COVID-19; patients who meet eligibility criteria will not be excluded on this basis.
Patients who meet any of the following criteria cannot be included in the study:
- receipt of any COVID-19 vaccine or participation in a COVID-19 vaccine study as a subject
- receipt of pooled immunoglobulin in the past 30 days
- invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- volume overload secondary to congestive heart failure or kidney failure
- unlikely to survive past 72 hours from screening based on the assessment of the investigator
- unlikely to follow up, or clinical assessment will be hindered by the patient’s poor functional status
Collaborating centers and PIs are listed below.
NYU Grossman School of Medicine/NYU Langone Health: Mila B. Ortigoza, MD, PhD
Albert Einstein College of Medicine/Montefiore Medical Center: Liise-anne Pirofski, MD, Hyunah Yoon, MD
Yale University School of Medicine: Mahalia Desruisseaux, MD
University of Miami Hospital and Clinics: Dushyantha Jayaweera, MD
The University of Texas Health Science Center, Houston: Luis Ostrosky, MD
The University of Texas Health Science Center, Tyler: Julie Philley, MD
The University of Texas, Rio Grande Valley: Andrew Dentino, MD
Johns Hopkins University: Christian Merlo, MD
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital: Reza Shaker, MD
St. Luke’s Advocate Aurora Health: Charles Brummitt, MD
National Center for Advancing Translational Sciences Clinical and Translational Science Awards:
- UL1 TR001445
- UL1 TR002556
- UL1 TR001863
- UL1 TR002736
- UL1 TR003167
- UL1 TR003098
CONTAIN Coordinating Center
Mila B. Ortigoza, MD, PhD, IND Holder, CONTAIN PI
Liise-anne Pirofski, MD, CONTAIN PI
Hyunah Yoon, MD, CONTAIN Co-PI
Gia Cobb, Project Manager
Monica Taveras, Data Manager
Keith Goldfeld, DrPH, Study Statistician
Yinxiang Wu, MA, Unblinded Assistant Research Scientist
Payal Patel, Programmer Daniel T. Stein, MD, Einstein Biorepository Director
Andrea Asencio, Unblinded Serology Data Manager
Resources for Current Investigators
Current investigators can login to access study materials.
To request more information about the trial, please email firstname.lastname@example.org.
Donate Convalescent Plasma
If you have recovered from COVID-19, you could help save the lives of others fighting this disease. Learn more about donating convalescent plasma.