Clinical trial NCT04665245: Symptom-Based Markers for COVID-19 Transmission
Official title: Contact Network Transmission Modeling of Healthcare Associated Infections: Symptom-Based Markers for COVID-19 Transmission
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Covid19
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients at the University of Iowa Hospitals \& Clinics (UIHC). Approximately 5,000 people have already tested positive for COVID-19 in Johnson County alone, and numbers are continuing to increase. The University of Iowa Hospitals \& Clinics see many patients from outside of Johnson County as well.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Tested positive for COVID-19

Exclusion Criteria:

* Prisoners
* Unable to provide own informed consent

Primary outcomes:
measure: Body Temperature
timeFrame: 10 days
measure: COVID-19 Symptoms
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Alberto M Segre, PhD
role: PRINCIPAL_INVESTIGATOR
References: