COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hydrogen peroxide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- recent positive SARS-CoV-2 PCER swab test
Exclusion Criteria:
- severe Covid19 disease
Sites / Locations
- Clinica Nuova ITOR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide
Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide
Outcomes
Primary Outcome Measures
The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test
A repeated SARS-CoV-2 PCR nose swab test after a previous positive SARS-CoV-2 PCR nose swab test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04878042
Brief Title
COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray
Official Title
The Negativisation Rate of Positive PCR Swab Tests for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Treatment With Hydrogen Peroxide: a Double-blind Placebo-controlled Randomised Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
EPISTATA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hydrogen peroxide is produced physiologically by oral bacteria and plays a significant role in the balance of oral microecology since it is an important antimicrobial agent. In the epithelial cells, the enzyme superoxide dismutase catalyzes a reaction leading from hydrogen peroxide to the ion superoxide. The induced oxidative stress stimulates a local innate response via activation of the toll-like receptors and the NF-κB. Those kinds of reactions are also activated by viral infections. Virus-induced oxidative stress plays an important role in the regulation of the host immune system and the specific oxidant-sensitive pathway is one of the effective strategies against viral infections. Therefore, nose/mouth/throat washing with hydrogen peroxide may enhance those local innate responses to viral infections. The investigators hypothesised that a treatment with a mouth wash and a nasal spray containing a diluted solution of hydrogen peroxide may accelerate the negativisation rate of a positive PCR swab test for SARS-CoV-2 (COVID-19).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide
Intervention Description
Mouth wash and nasal spray 3 times a day for 3 days
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Mouth wash and nasal spray 3 times a day for 3 days
Primary Outcome Measure Information:
Title
The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test
Description
A repeated SARS-CoV-2 PCR nose swab test after a previous positive SARS-CoV-2 PCR nose swab test
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- recent positive SARS-CoV-2 PCER swab test
Exclusion Criteria:
- severe Covid19 disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio I Lazzarino, MD PhD
Organizational Affiliation
EPISTATA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Nuova ITOR
City
Roma
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray
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