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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Body Temperature | Body temperature taken each morning and evening throughout COVID-19 infection period. | 10 days |
| COVID-19 Symptoms | 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). | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alberto M Segre, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Temperature | Body temperature taken each morning and evening throughout COVID-19 infection period. | Posted | Median | Standard Deviation | degrees Fahrenheit | 10 days | Submitted Temperatures | Submitted Temperatures |
|
|
10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelby Francis | University of Iowa | 319-678-8037 | shelby-francis@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2020 | Jan 8, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2024 | Jan 8, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| years |
|
| Sex: Female, Male | 6 participants did not complete the baseline survey to report their sex. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 6 participants did not complete the baseline survey to report their ethnicity. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 6 participants did not complete the baseline survey to report their race. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Submitted Temperatures |
|
|
| Primary | COVID-19 Symptoms | 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). | Posted | Count of Units | Submitted Symptoms | 10 days | Submitted Symptoms | Submitted Symptoms |
|
|
|
| 0 |
| 214 |
| 0 |
| 214 |
| 0 |
| 214 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Diarrhea |
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| Difficulty breathing |
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| Headache |
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| Nausea/vomiting |
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| Runny nose |
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| Shortness of breath |
|
| Sore throat |
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| None |
|