Contact Network Transmission Modeling of Healthcare Associated Infections: Symptom-Based Markers for COVID-19 Transmission
Conditions: Covid19
Sponsor: University of Iowa

Contact Network Transmission Modeling of 
Healthcare Associated Infections:  
 Identifying Effective Symptom-Based Markers for 
COVID-19 Transmission 
Study Protocol 
 
 
Date: 7/23/2020 
Version: 1.0 
 
Principal Investigator: Alberto Maria Segre, PhD 
 
Grant Number: U01CK000594 
 
Project/Grant Period: 8/1/2020 – 7/31/2025 
 
Clinical Trials Number: NCT04665245 
 
 
 

Protocol Version and Amendment Tracking 
 
Study Title: Contact Network Transmission Modeling of Healthcare Associated 
Infections: Identifying Effective Symptom-Based Markers for COVID-19 Transmission 
 
 
Version Number/Amendment 
 
 
Approval Date 
 
Original Protocol, Version 1.0 
 
 
07/23/2020 
 
 
 
 

Protocol Synopsis 
 
 
Protocol Title 
 
 
Contact Network Transmission Modeling of Healthcare 
Associated Infections: Identifying Effective Symptom-Based 
Markers for COVID-19 Transmission  
 
 
Main Criteria for Inclusion 
 
 
Tested positive for COVID-19 
 
 
Study Objective 
 
To further the understanding of COVID-19 symptom 
development throughout the infection period, as well as how 
those symptoms vary at different points of the day.  
 
 
 
 

Table of Contents 
 
 
Protocol Version and Amendment Tracking ..................................................................... 2 
Protocol Synopsis ......................................................................................................... 3 
Table of Contents .......................................................................................................... 4 
1. Introduction........................................................................................................... 5 
1.1 Background ...................................................................................................... 5 
2. Objective and Aim .................................................................................................. 5 
2.1 Objective ......................................................................................................... 5 
3. Subject Inclusion/Exclusion Criteria ........................................................................ 5 
3.1 Inclusion Criteria .............................................................................................. 5 
3.3 Exclusion Criteria ............................................................................................. 6 
4. Study Design ......................................................................................................... 6 
4.1 Overview .......................................................................................................... 6 
4.2 Recruitment/Screening Procedures ................................................................... 6 
4.3 Visit Procedures ............................................................................................... 6 
4.4 Statistical Analysis Plan .................................................................................... 7 
 
 
 
 
 

1. Introduction 
1.1 Background 
 
One important approach for decreasing COVID-19 transmission in healthcare settings is to 
prevent healthcare professionals from working while ill. Currently, facilities are asking screening 
questions and measuring temperatures to help identify symptomatic healthcare professionals 
and exclude them from providing patient care. Simulations can be used to inform the 
effectiveness of different screening approaches, but the results of these simulations depend 
upon the effectiveness of the intervention, e.g., the ability to identify healthcare professionals on 
their way to work, or to study the impact of healthcare professionals returning to work too early. 
Thus, simulations must necessarily depend upon realistic disease parameters: for example, it is 
suspected that a non-trivial proportion of patients with COVID-19 may be asymptomatic or have 
minimal symptoms, but the relative size of the asymptomatic subpopulation is unknown. 
 
The plan for this study is to develop a method for granular measurement of twice-daily 
symptoms from healthcare professionals and other research subjects of similar ages. After 
being diagnosed, the goal is to determine what symptoms participants have and how long they 
have had them. This will be done using a previously developed bidirectional texting platform to 
query participants about symptoms at least twice a day for ten days post diagnosis. Participants 
will be asked about subjective symptoms, including fevers, chills, cough, shortness of breath, 
fatigue, gastrointestinal symptoms, etc. They will also take their temperature twice daily during 
the recovery period, which will help determine the effectiveness of screening based on 
symptoms and/or thermometer readings. 
 
2. Objective and Aim  
2.1 Objective 
 
The goal of this trial is to further the understanding of COVID-19 symptom development 
throughout the infection period, as well as how those symptoms vary at different points of the 
day.  
 
3. Subject Inclusion/Exclusion Criteria 
3.1 Inclusion Criteria  
 
• 
Age 18 – 100 years 
• 
Able to speak and read English 
• 
Have tested positive for COVID-19 

3.3 Exclusion Criteria 
• 
prisoner status 
• 
unable to provide own written informed consent 
 
4. Study Design 
4.1 Overview 
 
In this study, COVID-19 positive patients will be added to a bidirectional texting program to 
receive daily surveys about their symptoms with the infection. This data will further the 
understanding of COVID-19 symptom development throughout the infection period, as well as 
how those symptoms vary at different points of the day. This study will be a single cohort, 
observational study of COVID-19 patients. 
 
4.2 Recruitment/Screening Procedures 
 
The research team will identify potentially eligible subjects by screening the COVID-19 Positive 
Results for Research report that is created in Epic. When a potentially eligible subject is 
identified, they will be contacted using the email address available in Epic. The potentially 
eligible subject will be sent an email with screening questions to determine their full eligibility 
(https://redcap.link/pgpqjs7n). If they are fully eligible, they will be directed to a REDCap 
informed consent document for them to electronically sign and return to the team. 
 
If participants do not respond to the initial email, they will be sent 1 additional email to see if 
they are interested in the study. If they still do not respond, they will not be contacted further. 
 
We will minimize coercion by telling them that their participation in the study is completely 
voluntary and will not have any impact on their treatment. Since the consent process takes 
place remotely, they will easily be able to read the study information and not complete the form, 
if they wish. 
 
4.3 Visit Procedures 
 
We will collect the following data from the patient's medical record: date of birth, date of COVID 
test, type of COVID test, and COVID test number. 
 
Immediately after the participant completes the online REDCap consent form, they will be 

directed to the baseline survey. The baseline survey asks for the participant's cell phone number 
so that we can send them the twice daily survey, the time in the morning they wish to receive 
text messages, the time in the evening they wish to receive text messages, their mailing 
address for the compensation check, sex assigned at birth, if they are pregnant (if female), race, 
ethnicity, if they have any of a list of health conditions that have been shown to be related to 
worse COVID outcomes, if they are a smoker, and if they have a thermometer that they are able 
to use for the study. If they do not have a thermometer, we will drop one off outside their home 
so that they have one to use for the study.  
 
Once that is complete, they will be entered into our bi-directional text messaging platform and 
sent 1 message every morning and 1 message every evening. These messages will remind 
them to measure their temperature and will ask about any current COVID-19 symptoms that 
they are experiencing. They will be sent text message reminders for 10 days.  
 
4.4 Statistical Analysis Plan 
 
We will calculate summary statistics for participants’ demographic characteristics (e.g., mean 
age, counts of comorbidities, percentage of females). We will also determine the progression of 
temperatures and symptoms over time. For example, we will determine when fevers occur, how 
many days fevers last, what symptoms are present, and how long symptoms last. 
This is a descriptive pilot study, so no power analysis was performed or required. 500 was 
chosen as the number to enroll because we need a large sample of participants to learn about 
the various symptoms of this condition. Also, due to the remote nature of the study and the fact 
that the population is already known to be ill, we expect a large number of dropouts during the 
course of the study.