Treatment-Control Study

On April 3, 2020 the Expanded Access Program (EAP) went live in the United States. On August 23, 2020 the FDA authorized emergency use of convalescent plasma. 

One key goal of the data collected through the EAP is to complete a treatment-control study, in which we match patients with COVID-19 to treated patients on risk characteristics, so that we might better understand the impact of convalescent plasma. This page serves to provide updates and materials for investigators participating in the treatment-control study or who would like to undertake their own treatment-control study.

GENERAL UPDATES - October 22 

  • The Technical Guidance has been updated to include guidance on Phase 2 data submission. Please see important note about Phase 2 below. 
  • Timetable: We would like to have all Phase 1 data submitted by the end of October 2020. Please just do your best to expedite the movement of the required information to the Mayo SharePoint in as timely a fashion as possible. Our findings will be important to treatment policies and practices for COVID, and the FDA is very interested in what we learn from this study.  
  • When submitting data to the SharePoint, please include the following in your file title: date, a version control of your choosing, and institution name. 
  • A note about site reimbursement has been added below. 

Important Note About Phase 2: 

  • If your hospital has already submitted Phase 1 data:  
    • We are working hard to match treated to controls from Phase 1 data. Once we have completed matching for your institution, you will recieve an email with the IDs of those we were able to successfully match. You can then pull Phase 2 variables on these matches. 
    • If you submitted Phase 1 data early on (ie. June or early July), and have a significant number of participants from the date you submitted until August 20, please consider submitting Phase 1 data on these participants before extracting Phase 2 data. 
  • If your hospital has not yet submitted Phase 1 data: If your hospital has not yet submitted Phase 1 data, you have two options for data submission. We recommend the first option listed below, but will accept either. 
    • Option 1: If your institution has not yet submitted Phase 1 data, we recommend your institution submits Phase 1 and 2 data on all participants in one data pull. This way, we can match based on your Phase 1 variables, and will have the Phase 2 data readily available.  
    • Option 2: If one data pull with Phase 1 and 2 data is not feasible for your institution, we ask that you submit Phase 1 data on your participants by October 31st so our team can successfully match and send the IDs for the Phase 2 request by November 16th. 

Updated Treatment-Control Study Protocol: Version 1.0 of our most recent study protocol is now available.  

Technical Guide for Electronic Health Record Data Retrieval: Our team has worked together to provide participating institutions with a technical guide (v1.4) for the data acquisition and transfer. Participating institutions can reach out to Breanna Kornatowski at kornatow@msu.edu for the SharePoint link mentioned in 2.8 Step 8. Technical guidance for Phase 2 will be posted the week of October 5.

Data Use Agreements: For information and materials on data use agreements, please email uscovidplasma@mayo.edu .

Site Remuneration: The Mayo Clinic has approved a modification to the EAP Treatment-Control study to include site remuneration for the administrative and technical time in the treatment-control study at the rate of $100 per each patient record used as either a treatment case or a non-treatment control in the analysis.

IRB: On June 11th, the Mayo Clinic IRB approved a modification to the original approval that allowed the EAP to be set up, to include the case-control data collection from de-identified electronic medical records. Mayo Clinic Notice of Approval.

Office Hours: An advisory team which will include expertise from the research team at MSU, the EPIC EMR, and the MITRE corporation will hold virtual "office hours" twice a week to address questions regarding the protocol, data transfer, technical issues, and any other questions you may have. These sessions will be held on Tuesdays and Thursdays from 11am-12pm Eastern Time. Please email Breanna Kornatowski at kornatow@msu.edu for a Zoom link for virtual office hours.

Questions: For questions pertaining to the treatment-control study, please email Breanna Kornatowski at kornatow@msu.edu.