Trial Outcomes & Findings for The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients (NCT NCT04941131)
NCT ID: NCT04941131
Last Updated: 2025-06-12
Results Overview
Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Chlorhexidine Digluconate Mouthwash
This is a mouth wash that can be used over the counter.
|
Chlorhexidine Digluconate Lozenges
This is a mouth wash that can be used over the counter.
|
Povidone Iodine Mouthwash
This is a mouth wash that can be used over the counter.
|
Tap Water
It is regular tap water
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
Baseline characteristics by cohort
| Measure |
Chlorhexidine Digluconate Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Chlorhexidine Digluconate Lozenges
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Povidone Iodine Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Tap Water
n=15 Participants
It is regular tap water
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.80 Year
STANDARD_DEVIATION 11.24 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
36.20 Year
STANDARD_DEVIATION 13.21 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
33.86 Year
STANDARD_DEVIATION 10.29 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
41.73 Year
STANDARD_DEVIATION 17.14 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
37.40 Year
STANDARD_DEVIATION 13.21 • n=60 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
3 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
4 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
4 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
18 Participants
n=60 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
12 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
11 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
11 Participants
n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
42 Participants
n=60 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
E genes
|
26.23 Cycle
STANDARD_DEVIATION 7.37 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
26.14 Cycle
STANDARD_DEVIATION 5.98 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
25.85 Cycle
STANDARD_DEVIATION 6.33 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
27.59 Cycle
STANDARD_DEVIATION 5.01 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
26.44 Cycle
STANDARD_DEVIATION 6.01 • n=60 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
|
S genes
|
25.03 Cycle
STANDARD_DEVIATION 6.63 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
24.83 Cycle
STANDARD_DEVIATION 5.13 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
25.18 Cycle
STANDARD_DEVIATION 6.35 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
26.11 Cycle
STANDARD_DEVIATION 4.04 • n=15 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
25.24 Cycle
STANDARD_DEVIATION 5.53 • n=60 Participants • We have 15 participants per group assigned in the protocol. The range was between 12 to 15 max. We were able to get the max in each group
|
PRIMARY outcome
Timeframe: 6 monthsGene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.
Outcome measures
| Measure |
Chlorhexidine Digluconate Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Chlorhexidine Digluconate Lozenges
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Povidone Iodine Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Tap Water
n=15 Participants
It is regular tap water
|
|---|---|---|---|---|
|
E Genes
|
28.50 Cycle
Standard Deviation 5.21
|
27.33 Cycle
Standard Deviation 4.9
|
30.28 Cycle
Standard Deviation 6.33
|
27.80 Cycle
Standard Deviation 4.33
|
SECONDARY outcome
Timeframe: 6 monthsGene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the S gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.
Outcome measures
| Measure |
Chlorhexidine Digluconate Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Chlorhexidine Digluconate Lozenges
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Povidone Iodine Mouthwash
n=15 Participants
This is a mouth wash that can be used over the counter.
|
Tap Water
n=15 Participants
It is regular tap water
|
|---|---|---|---|---|
|
S Genes
|
27.86 Cycle
Standard Deviation 5.89
|
26.74 Cycle
Standard Deviation 5.27
|
28.09 Cycle
Standard Deviation 6.37
|
27.87 Cycle
Standard Deviation 3.83
|
Adverse Events
Chlorhexidine Digluconate Mouthwash
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine Digluconate Lozenges
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Povidone Iodine Mouthwash
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tap Water
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place