Trial Outcomes & Findings for Symptom-Based Markers for COVID-19 Transmission (NCT NCT04665245)

NCT ID: NCT04665245

Last Updated: 2026-01-26

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 214 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2026-01-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	214
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	18

Baseline Characteristics

6 participants did not complete the baseline survey to report their sex.

Baseline characteristics by cohort

Measure	COVID-19 Positive Patients n=214 Participants 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.
Age, Continuous	37.5 years STANDARD_DEVIATION 13.5 • n=214 Participants
Sex: Female, Male Female	128 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their sex.
Sex: Female, Male Male	80 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their sex.
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their ethnicity.
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their ethnicity.
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their ethnicity.
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) Asian	4 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) Black or African American	7 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) White	192 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) More than one race	0 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=208 Participants • 6 participants did not complete the baseline survey to report their race.
Region of Enrollment United States	214 participants n=214 Participants

PRIMARY outcome

Timeframe: 10 days

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

Outcome measures

Measure	COVID-19 Positive Patients n=3 Submitted Temperatures 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.
Body Temperature	98.1 degrees Fahrenheit Standard Deviation 0.85

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	COVID-19 Positive Patients n=8910 Submitted Symptoms 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.
COVID-19 Symptoms Body or muscle aches	956 Submitted Symptoms
COVID-19 Symptoms Cough	1532 Submitted Symptoms
COVID-19 Symptoms Decreased sense of taste and/or smell	1669 Submitted Symptoms
COVID-19 Symptoms Diarrhea	305 Submitted Symptoms
COVID-19 Symptoms Difficulty breathing	141 Submitted Symptoms
COVID-19 Symptoms Headache	1140 Submitted Symptoms
COVID-19 Symptoms Nausea/vomiting	168 Submitted Symptoms
COVID-19 Symptoms Runny nose	1096 Submitted Symptoms
COVID-19 Symptoms Shortness of breath	388 Submitted Symptoms
COVID-19 Symptoms Sore throat	747 Submitted Symptoms
COVID-19 Symptoms None	768 Submitted Symptoms

Adverse Events

COVID-19 Positive Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shelby Francis

University of Iowa

Phone: 319-678-8037

Email: shelby-francis@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place