Study Stopped
No participants
COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray
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.
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2021
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 23, 2022
November 1, 2022
2 months
May 4, 2021
November 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
4 days
Study Arms (2)
Active
EXPERIMENTALMouth wash and nasal spray containing a diluted solution of hydrogen peroxide
Placebo
PLACEBO COMPARATORMouth wash and nasal spray not containing a diluted solution of hydrogen peroxide
Interventions
Eligibility Criteria
You may qualify if:
- \- recent positive SARS-CoV-2 PCER swab test
You may not qualify if:
- \- severe Covid19 disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EPISTATAlead
Study Sites (1)
Clinica Nuova ITOR
Roma, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio I Lazzarino, MD PhD
EPISTATA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
April 9, 2021
Primary Completion
June 1, 2021
Study Completion
July 1, 2021
Last Updated
November 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share