Trial Outcomes & Findings for Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19 (NCT NCT04347538)
NCT ID: NCT04347538
Last Updated: 2024-10-15
Results Overview
Perform qPCR Analysis to asses viral shedding over 21 day study period. Data expressed as viral shedding of N1 protein. Viral shedding = log10(change values at first day to the max value of Ct)/days between two values.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Day 1 to day 21
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Saline With Baby Shampoo Nasal Irrigation
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
|
Saline Nasal Irrigation
Nasal irrigation BID with normal saline
Saline Nasal Irrigation: Saline nasal irrigation BID
|
Control Group, No Intervention
control group, no nasal irrigation
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
31
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
7
|
Reasons for withdrawal
| Measure |
Saline With Baby Shampoo Nasal Irrigation
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
|
Saline Nasal Irrigation
Nasal irrigation BID with normal saline
Saline Nasal Irrigation: Saline nasal irrigation BID
|
Control Group, No Intervention
control group, no nasal irrigation
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
7
|
Baseline Characteristics
Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
Baseline characteristics by cohort
| Measure |
Saline With Baby Shampoo Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
|
Saline Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline
Saline Nasal Irrigation: Saline nasal irrigation BID
|
Control Group, No Intervention
n=24 Participants
control group, no nasal irrigation
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
23 Participants
n=24 Participants
|
70 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=72 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 18 • n=24 Participants
|
39 years
STANDARD_DEVIATION 15 • n=24 Participants
|
39 years
STANDARD_DEVIATION 15 • n=24 Participants
|
39 years
STANDARD_DEVIATION 23 • n=72 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
12 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
10 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
37 Participants
n=72 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
|
Sex: Female, Male
Male
|
9 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
12 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
14 Participants
n=24 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
35 Participants
n=72 Participants • Analysis population includes those who were screened, enrolled, and completed follow up. Data on participant sex was only collected for 72 participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
72 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 21Perform qPCR Analysis to asses viral shedding over 21 day study period. Data expressed as viral shedding of N1 protein. Viral shedding = log10(change values at first day to the max value of Ct)/days between two values.
Outcome measures
| Measure |
Saline With Baby Shampoo Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
|
Saline Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline
Saline Nasal Irrigation: Saline nasal irrigation BID
|
Control Group, No Intervention
n=24 Participants
control group, no nasal irrigation
|
|---|---|---|---|
|
Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection
|
.116 Log10 copies/mL/days
Interval -0.031 to 0.333
|
.071 Log10 copies/mL/days
Interval -0.047 to 0.253
|
.118 Log10 copies/mL/days
Interval -0.083 to 0.33
|
SECONDARY outcome
Timeframe: 21 daysIdentify symptom burden at day 5 using the modified Wisconsin Upper Respiratory System Survey 21. Minimum = 0. Maximum =21. Higher scores represent a worse outcomes.
Outcome measures
| Measure |
Saline With Baby Shampoo Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
|
Saline Nasal Irrigation
n=24 Participants
Nasal irrigation BID with normal saline
Saline Nasal Irrigation: Saline nasal irrigation BID
|
Control Group, No Intervention
n=24 Participants
control group, no nasal irrigation
|
|---|---|---|---|
|
Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-2
|
13 score on a scale
Standard Deviation 14
|
16.3 score on a scale
Standard Deviation 17.8
|
16.4 score on a scale
Standard Deviation 11.8
|
Adverse Events
Control Group, No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Nasal Irrigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline With Baby Shampoo Nasal Irrigation
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
Justin H. Turner, MD, PhD
Vanderbilt University Medical Center
Phone: 615-343-8848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place