Symptom-Based Markers for COVID-19 Transmission

NCT ID: NCT04665245

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-05-19

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 Positive Patients

The study only includes one cohort: COVID-19 positive patients. Enrollees will not receive any therapeutic intervention; participants will simply report their temperature and any symptoms experienced twice per day for 10 days.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Fluent in English
• Tested positive for COVID-19

Exclusion Criteria

• Prisoners
• Unable to provide own informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Alberto Maria Segre

Professor, Chair, Department of Computer Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto M Segre, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202007450

Identifier Type: -

Identifier Source: org_study_id