Symptom-Based Markers for COVID-19 Transmission

Sponsor
University of Iowa (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04665245
Collaborator
(none)
500
1
23.5
21.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Contact Network Transmission Modeling of Healthcare Associated Infections: Symptom-Based Markers for COVID-19 Transmission
    Actual Study Start Date :
    Dec 15, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Body Temperature [10 days]

      Body temperature taken each morning and evening throughout COVID-19 infection period.

    2. COVID-19 Symptoms [10 days]

      Any symptoms experienced throughout COVID-19 infection period (aches, cough, decreased sense of taste and/or smell, diarrhea, difficulty breathing, headache, nausea, runny nose, sore throat, shortness of breath).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Fluent in English

    • Tested positive for COVID-19

    Exclusion Criteria:
    • Prisoners

    • Unable to provide own informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • University of Iowa

    Investigators

    • Principal Investigator: Alberto M Segre, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alberto Maria Segre, Professor, Chair, Department of Computer Science, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT04665245
    Other Study ID Numbers:
    • 202007450
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2022