Treatment-Control Study

On April 3, 2020 the Expanded Access Program went live in the United States. The goal of this program was to infuse patients with convalescent plasma for compassionate use. 11,106 physicians have infused 38,605 patients with convalescent plasma as of July 20, 2020.

One key goal 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 - June 25

  • A new tech guide (v1.3) can be found below. 
  • Dates: We realize that the language in the technical guide was ambiguous in its definition of the start date of the study.To calculate the start date of the study, choose the earliest admission date of all patients in the data set who received convalescent plasma, regardless of when plasma was administered. Consider this example:
    • Patient A is admitted April 1. She receives plasma on April 7. 
    • Patient B is admitted April 3. He receives plasma on April 5.
    • The start date of the study should be April 1.  
  • Timetable: Please just do your best to expedite the movement of the required information to the Mayo website 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.  

 

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 (v1.3) 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. 

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

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.