Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04665245 |
| Other study ID # |
202007450 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2020 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Iowa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
