Trial Outcomes & Findings for Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients (NCT NCT04410159)
NCT ID: NCT04410159
Last Updated: 2020-07-21
Results Overview
Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 6
Results posted on
2020-07-21
Participant Flow
All patients were recruited 2 to 3 days after date of diagnosis (nasophryngeal swab postive for SARS-C0V-2. All patients were asymptomatic and admitted to the hospital for observation
No significant event occurred after enrollment
Participant milestones
| Measure |
Povidone-iodine
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group received the standard treatment protocol without any additional intervention
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 12.50 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 3.77 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 2.68 • n=4 Participants
|
30.6 years
STANDARD_DEVIATION 7.91 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Malaysia
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 6Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart
Outcome measures
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Number of Participants With Early Viral Clearance
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 12RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12
Outcome measures
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Number of Participants With Negative RT-PCR Results
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 12Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation
Outcome measures
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Number of Patients That Progress to More Severe Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0-14abnormal chest x-ray or CT scan
Outcome measures
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Radiological Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0-14Abnormal absolute lymphocytic count Abnormal C-reactive protein
Outcome measures
| Measure |
Povidone-iodine
n=5 Participants
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle
|
Essential Oils
n=5 Participants
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle
|
Tap Water
n=5 Participants
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle
|
Control
n=5 Participants
This group will receive the standard treatment protocol without any additional intervention
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Laboratory Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Povidone-iodine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Essential Oils
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
Control
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
NURUL AZMAWATI MOHAMED
UNIVERSITI SAINS ISLAM MALAYSIA
Phone: +603 42892400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place