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Mouth Rinses for Inactivation of COVID-19 (MOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584684
Recruitment Status : Terminated (The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons)
First Posted : October 14, 2020
Results First Posted : March 25, 2024
Last Update Posted : March 25, 2024
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Covid19
Coronavirus Infection
SARS-CoV-2 Infection
Interventions Other: 0.9% w/v NaCL Saline
Drug: 1.5% w/v Hydrogen Peroxide
Drug: 0.12% Chlorohexidine Gluconate
Drug: 27% Ethanol plus essential oils
Drug: 0.5% w/v Povidone-iodide
Drug: 0.075% Cetylpyridinium Chloride
Enrollment 128
Recruitment Details  
Pre-assignment Details One participant who signed informed consent was unable to provide an adequate amount of saliva at Baseline and subsequently withdrew from the study.
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Hide Arm/Group Description

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

Period Title: Overall Study
Started 21 27 22 19 20 19
Completed 21 27 22 19 19 19
Not Completed 0 0 0 0 1 0
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate Total
Hide Arm/Group Description

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

Total of all reporting groups
Overall Number of Baseline Participants 21 27 22 19 20 19 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 27 participants 22 participants 19 participants 20 participants 19 participants 128 participants
<=18 years
2
   9.5%
0
   0.0%
1
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
3
   2.3%
Between 18 and 65 years
19
  90.5%
27
 100.0%
20
  90.9%
19
 100.0%
20
 100.0%
19
 100.0%
124
  96.9%
>=65 years
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 27 participants 22 participants 19 participants 20 participants 19 participants 128 participants
Female
12
  57.1%
18
  66.7%
13
  59.1%
10
  52.6%
11
  55.0%
10
  52.6%
74
  57.8%
Male
9
  42.9%
9
  33.3%
9
  40.9%
9
  47.4%
9
  45.0%
9
  47.4%
54
  42.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 27 participants 22 participants 19 participants 20 participants 19 participants 128 participants
Hispanic or Latino
2
   9.5%
2
   7.4%
3
  13.6%
1
   5.3%
2
  10.0%
1
   5.3%
11
   8.6%
Not Hispanic or Latino
19
  90.5%
25
  92.6%
19
  86.4%
18
  94.7%
18
  90.0%
18
  94.7%
117
  91.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 27 participants 22 participants 19 participants 20 participants 19 participants 128 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
2
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.5%
8
  29.6%
2
   9.1%
2
  10.5%
3
  15.0%
3
  15.8%
20
  15.6%
White
18
  85.7%
19
  70.4%
18
  81.8%
17
  89.5%
16
  80.0%
16
  84.2%
104
  81.3%
More than one race
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
2
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 27 participants 22 participants 19 participants 20 participants 19 participants 128 participants
21
 100.0%
27
 100.0%
22
 100.0%
19
 100.0%
20
 100.0%
19
 100.0%
128
 100.0%
1.Primary Outcome
Title Change in Salivary Viral RNA Level of SARS-CoV-2
Hide Description Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).
Time Frame Baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants were excluded due to inadequate saliva samples.
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Hide Arm/Group Description:

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

Overall Number of Participants Analyzed 21 27 22 19 18 18
Mean (Standard Deviation)
Unit of Measure: copies/20μL sample
SARS CoV-2 N1 -209759  (856748.68) -6298  (34132.53) -386  (8311.31) -44851  (115895.74) -5319  (24672.60) 8318  (26480.13)
SARS CoV-2 N2 -440282  (1807805.86) -1818  (22088.58) 32  (8030.75) -79681  (209740.80) -7195  (24253.04) -2999  (34067.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 27% Ethanol Plus Essential Oils
Comments SARS CoV-2 N1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.075% Cetylpyridinium Chloride
Comments SARS CoV-2 N1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 1.5% w/v Hydrogen Peroxide
Comments SARS CoV-2 N1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.5% w/v Povidone-iodide
Comments SARS CoV-2 N1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.12% Chlorhexidine Gluconate
Comments SARS CoV-2 N1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 27% Ethanol Plus Essential Oils
Comments SARS CoV-2 N2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.075% Cetylpyridinium Chloride
Comments SARS CoV-2 N2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 1.5% w/v Hydrogen Peroxide
Comments SARS CoV-2 N2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.5% w/v Povidone-iodide
Comments SARS CoV-2 N2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 0.9% w/v NaCl, 0.12% Chlorhexidine Gluconate
Comments SARS CoV-2 N2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments The a priori threshold for statistical significance is <0.05.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Change in Rapid Antigen Test Salivary Protein Levels of SARS-CoV-2
Hide Description Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using rapid antigen test as back-up if qPCR analysis is not possible. If the Rapid Antigen Test is needed and proves infeasible, an alternative test (i.e., sandwich ELISA) will be used.
Time Frame Baseline, 30 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The proposed qPCR method proved feasible with an updated protocol. As a result, the alternative method (i.e., rapid antigen test) was unnecessary and therefore not conducted.
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Hide Arm/Group Description:

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Change in Salivary Protein Antigen Levels of SARS-CoV-2
Hide Description Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using sandwich ELISA assay as back-up if qPCR analysis is not possible. If the sandwich ELISA assay proves infeasible, an alternative test (i.e., Rapid Antigen Test) will be used.
Time Frame Baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The proposed qPCR method proved feasible with an updated protocol. As a result, the alternative method (i.e., sandwich ELISA assay) was unnecessary and therefore not conducted.
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Hide Arm/Group Description:

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Change in Salivary Viral Infectivity of SARS-CoV-2
Hide Description Determination of SARS-CoV-2 viral infectivity using an in vitro infectivity assay.
Time Frame Baseline, 30 Minutes
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Participants' Willingness to Use Mouthrinse
Hide Description The Mouthrinse questionnaire was used to understand the acceptability of mouthrinse use by participants in a clinical setting. It asks participants to respond to 14 questions answering the following: "As I read the following list of situations, please tell me how willing you would be to using a mouth rinse in that situation." Possible responses for each question are: ("Very willing"; "Somewhat willing"; "Somewhat unwilling"; "Very unwilling"; and "NA").
Time Frame After using mouthrinse, between 0-minute and 15-minute saliva collection
Outcome Measure Data Not Reported
Time Frame From the time of signing informed consent through completion of the approximately 1.5-hour visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Hide Arm/Group Description

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl.

0.9% w/v NaCl: Saline placebo rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.

27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.

0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.

1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.

0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse

Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.

0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse

All-Cause Mortality
0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/27 (0.00%)   0/22 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/27 (0.00%)   0/22 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.9% w/v NaCl 27% Ethanol Plus Essential Oils 0.075% Cetylpyridinium Chloride 1.5% w/v Hydrogen Peroxide 0.5% w/v Povidone-iodide 0.12% Chlorhexidine Gluconate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/27 (0.00%)   0/22 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Jacox, DMD, PhD, MS
Organization: University of North Carolina at Chapel Hill
Phone: 847-702-0988
EMail: ljacox@live.unc.edu
Publications:
State Officials Announce Latest COVID-19 Facts Including New Data on Racial Demographics and Expanded Health Care Worker Data. California Department of Public Health (2020).
Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
Pfefferle, S. et al.Low and high infection dose transmission of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany. medRxiv(2020) doi:10.1101/2020.06.11.20127332.
Kirk-Bayley, J., Challacombe, S., Sunkaraneni, V. & Combes, J. The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection. SSRN Electron. J.(2020) doi:10.2139/ssrn.3563092.
COVID-19 Frequently Asked Questions. American Dental Assocation: Center for Professional Sucess(2020).
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04584684    
Other Study ID Numbers: 20-2040
First Submitted: October 9, 2020
First Posted: October 14, 2020
Results First Submitted: January 27, 2023
Results First Posted: March 25, 2024
Last Update Posted: March 25, 2024