- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665245
Symptom-Based Markers for COVID-19 Transmission
Contact Network Transmission Modeling of Healthcare Associated Infections: Symptom-Based Markers for COVID-19 Transmission
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals & Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fluent in English
- Tested positive for COVID-19
Exclusion Criteria:
- Prisoners
- Unable to provide own informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Temperature
Time Frame: 10 days
|
Body temperature taken each morning and evening throughout COVID-19 infection period.
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10 days
|
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COVID-19 Symptoms
Time Frame: 10 days
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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).
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10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alberto M Segre, PhD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202007450
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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