COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray

NCT ID: NCT04878042

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2021-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active

Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide

Group Type EXPERIMENTAL

Hydrogen peroxide

Intervention Type DEVICE

Mouth wash and nasal spray 3 times a day for 3 days

Placebo

Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Mouth wash and nasal spray 3 times a day for 3 days

Interventions

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Hydrogen peroxide

Mouth wash and nasal spray 3 times a day for 3 days

Intervention Type DEVICE

Placebo

Mouth wash and nasal spray 3 times a day for 3 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- recent positive SARS-CoV-2 PCER swab test

Exclusion Criteria

\- severe Covid19 disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EPISTATA

NETWORK

Sponsor Role lead

Responsible Party

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Antonio Lazzarino

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio I Lazzarino, MD PhD

Role: PRINCIPAL_INVESTIGATOR

EPISTATA

Locations

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Clinica Nuova ITOR

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20121617

Identifier Type: -

Identifier Source: org_study_id

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