Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers
Phase: NA
Conditions: SARS-CoV 2, COVID-19
Sponsor: Mayo Clinic

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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IRB Minimal Risk Protocol Template  
 
General Study Information 
 
Principal Investigator:      Mark Parkulo, MD  
 
 
 
 
 
 
 
 
Study Title:    Seroprevalence of SARS CoV 2 Antibodies in Previously undiagnosed Healthcare Workers 
 
Protocol version number and date:    Version 1.0 04/17/2020  
 
Research Question and Aims 
 
Hypothesis: Healthcare workers with suspected COVID-19 exposure and negative test demonstrate 
seroprevalence of SARS CoV 2 Antibodies. 
 
Aims, purpose, or objectives: To identify healthcare workers with SARS CoV 2 antibodies who have not been 
previously diagnosed and are presumed COVID-19 negative and determine the level of immunity in this 
population which could inform further decisions about widespread antibody testing in a healthcare worker 
population.  
 
Background:   
Very little is known about the seroprevalence of SARS CoV-2 Antibodies in a healthcare employee population.  
Some are recommending antibody testing for healthcare workers on a broad scale to determine immunity.  
Antibody testing is now available at Mayo Clinic in Florida. 
 
Study Design and Methods 
 
Methods:  Describe in lay terms, completely detailing the research activities that will be conducted by Mayo 
Clinic staff under this protocol. 
 
Healthcare workers in surgical and procedural areas will be contacted to participate in this study. Those 
employees, who were identified as potentially being exposed to COVID-19 and were screened with PCR testing 
twice (with negative results), will be asked to participate in this study to check for antibodies presence in their 
blood. Principal Investigator and Co-Investigators will reach out to those employees and offer them 
participation in this study. A list of employees will be obtained from the Employee Health and Principal 
Investigator already confirmed that this list will be available as soon as study is approved by IRB. 
 
Upon agreement to participate in this study, the participants will complete a brief survey (attached). 
 
Responses to questions will be directly entered into REDCap and captured by the study team members.  
 
Study participants will be asked to have a blood test for antibodies performed at Mayo Clinic Florida. 
Approximately 5ml of blood will be obtained for this test. The charge for this test is being covered by the 
participants’ insurance per CARES Act.  

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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Official letter from Mayo Clinic to Medica included in the IRB application. Per email discussion with Cathryn 
Fraser, Christina Zorn, and Mark Parkulo, MD, the antibodies testing will be paid for by Medica for employees 
covered by this insurance. 
 
Should results come back with presence of antibodies; the employees will be notified and instructed to follow 
up with their PCP. The test is not aimed at detecting presence of COVID-19, only antibodies.  
 
Subject Information 
 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources.    
 
Target accrual: 300 
 
Subject population (children, adults, groups):  Adults 
 
Inclusion Criteria:  
 
• Age ≥ 18 years old 
• Mayo Clinic employee in procedural and surgical area 
• Suspected COVID-19 exposure 
• Completed PCR test twice with negative results 
 
 
Exclusion Criteria:   
 
• Refusal to participate in this study 
• Subject not covered by Medica insurance 
 
 
 
Biospecimens 
 
Collection of blood samples. When multiple groups are involved copy and paste the appropriate section below 
for example repeat section b when drawing blood from children and adults with cancer.  
 
a. From healthy, non-pregnant, adult subjects who weigh at least 110 pounds. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed 550ml in an 8 week period 
and collection may not occur more frequently than 2 times per week. 
Volume per blood draw: 5 ml   
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) single draw 
 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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b. From other adults and children considering age, weight, and health of subject. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed the lesser of 50 ml or 3 ml 
per kg in an 8 week period, and collection may not occur more frequently than 2 times per week.   
Volume per blood draw: ml 
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) ___ ________  
 
Prospective collection of biological specimens other than blood: _____ _________________________ 
 
 
Review of medical records, images, specimens  
 
 
Check all that apply (data includes medical records, images, specimens).  
 
  Only data that exists before the IRB submission date will be collected.   
 
Date Range for Specimens and/or Review of Medical Records:   
Examples: 01/01/1999 through 12/31/2015, or all records through mm/dd/yyyy.  
 
Note: The Date Range must include the period for collection of baseline data, as well as follow-up data, 
if applicable. 
 
  The study involves data that exist at the time of IRB submission and data that will be generated after IRB 
submission. Include this activity in the Methods section.  
Examples 
• The study plans to conduct a retrospective chart review and ask subjects to complete a questionnaire.  
• The study plans to include subjects previously diagnosed with a specific disease and add newly 
diagnosed subjects in the future.  
 
  The study will use data that have been collected under another IRB protocol. Include in the Methods section 
and enter the IRB number from which the research material will be obtained. When appropriate, note when 
subjects have provided consent for future use of their data and/or specimens as described in this protocol.  
 
Enter one IRB number per line, add more lines as needed 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 
Data Analysis 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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Power analyses may not be appropriate if this is a feasibility or pilot study, but end-point analysis plans are 
always appropriate even if only exploratory. Provide all information requested below, or provide justification if 
not including all of the information.  
 
Power Statement:   
This is an exploratory study and power statement is not applicable at this time. 
 
Data Analysis Plan:  
Descriptive statistics and mean, median will be reported for the entire data set. The information will be 
deducted based on the frequency of identified healthcare workers with demonstrated immunity to COVID-19. 
 
Endpoints 
Primary:  
Secondary: