Continuous Monitoring of Pooled International Trials of Convalescent Plasma for COVID-19 Hospitalized Patients
As the coronavirus disease (COVID-19) pandemic continues to surge, shifting hotspots have resulted in an emerging problem for clinical trials: there is a mismatch between the location of enrolling sites and the current incidence of COVID-19 outbreaks. As a result, many randomized controlled trials (RCTs) are unable to meet their enrollment target.
The COVID-19 pandemic remains a humanitarian crisis because of the uncontrolled spread of SARS-CoV-2, with hospitalizations and deaths often occurring weeks after exposure. The urgent need for lifesaving therapies is greater than ever. To determine whether a therapy is safe and effective as soon as possible, investigators at NYU Langone propose a real-time pooling of individual patient data from ongoing RCTs.
Led by principal investigator (PI) Andrea B. Troxel, ScD, from NYU Langone Health, Continuous Monitoring of Pooled International Trials of Convalescent Plasma for COVID-19 Hospitalized Patients (COMPILE) has been initiated. COMPILE consists of a secure central repository for the pooled data that will be continuously updated with new data at two-week intervals. Unblinded biostatisticians will conduct the interim analyses and report to an umbrella data and safety monitoring board. When evidence with a high degree of confidence emerges, the data and safety monitoring board will make a joint recommendation to the leadership of all trials.
Below is a schematic representation of the COMPILE project. The data sharing agreement will govern publications and other aspects of the pooling. A secure central data repository will host deidentified individual patient data and an umbrella data and safety monitoring board will regularly monitor the accumulating evidence. The plans for publication and subsequent analyses are shown on the right side of the schema.
Read our recent article in The Journal of the American Medical Association about this project.
Resources for Investigators
If you have questions to discuss with project leadership, email Dr. Troxel at firstname.lastname@example.org.
If you are interested in participating in the pooling project, please submit a signed statement of interest.
Information for Collaborators
If you are involved in a trial of convalescent plasma for patients hospitalized with COVID-19 and would like to participate in the COMPILE pooling project, you will be asked to sign a consortium agreement that sets out the rules for participation and collaboration among the various trial teams. If required by your local institution, the appropriate institutional representative will also need to sign the agreement.
You will also be asked to complete a short survey to capture information about the status of antibody assessment in donor (and, if used, control) plasma and in the trial subject who receives the transfusion.
After we receive the requested documents, we will return the fully executed and countersigned consortium agreement. We will also provide login credentials for the COMPILE consortium website, detailed technical instructions on how to proceed with data transmissions, and a schedule of conference calls and consortium communications.
To begin the process of participating in the COMPILE pooling project, please submit a signed statement of interest.
See below for details about RCT protocol titles, locations, and site PIs.
A Randomized, Open-Label, Adaptive, Proof-of-Concept Clinical Trial of Donated Antibodies Working Against COVID-19 (DAWN-PLASMA)
University Hospitals Leuven (UZ Leuven), Leuven, Belgium: Geert Meyfroidt, MD, PhD
Convalescent Plasma in the Management of Moderate COVID-19 in India: An Open-Label Parallel-Arm Phase II Multicentre Randomized Controlled Trial (PLACID Trial)
Indian Council of Medical Research (ICMR), New Delhi, India: Aparna Mukherjee, MD, PhD
Brasília Covid-19 Convalescent Plasma (BCCP)
Faculty of Medicine of the University of Brasília, Brazil: André Moraes Nicola, MD
Convalescent Plasma from Recovered Patients to Treat Severe SARS-CoV-2 Disease (CONCOVID Study)
Erasmus University Medical Center, Rotterdam, The Netherlands: B.J.A. (Bart) Rijnders, MD, PhD
CONTAIN COVID-19: A Convalescent Plasma To Limit Coronavirus Associated Complications
NYU Langone Health, New York, NY: Mila B. Ortigoza, MD, PhD
Albert Einstein College of Medicine, New York, NY: Liise-anne Pirofski, MD
Yale University, New Haven, CT: Mahalia Desruisseaux, MD
University of Miami, Miami, FL: Ralph Sacco, MD
University of Texas, Houston, TX: David McPherson, MD
ConPlas-19, a Multicenter, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain: Cristina Avendaño-Solá, Rafael Duarte
A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma to Non-Immune Plasma to Limit Coronavirus Associated Complications in Hospitalized Patients
University of California, San Francisco, CA: Annie Luetkemeyer, MD, Priscilla Hsue, MD
An Open-Label, Controlled, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill, Hospitalized Participants with COVID-19 Pneumonia Caused by SARS-CoV-2
University of Pennsylvania, Philadelphia, PA: Katharine Bar, MD