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

Not Applicable

Withdrawn

• Conditions: COVID-19
• Interventions: Device: Hydrogen peroxide; Device: Placebo

• Registration Number: NCT04878042
• Lead Sponsor: EPISTATA

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Primary Completion: 2021-06
• Study Completion: 2021-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-20
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• recent positive SARS-CoV-2 PCER swab test

Exclusion Criteria

• severe Covid19 disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Hydrogen peroxide	Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide
Placebo	Placebo	Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide

Primary Outcome Measures

Name	Time	Method
The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test	4 days	A repeated SARS-CoV-2 PCR nose swab test after a previous positive SARS-CoV-2 PCR nose swab test

Trial Locations

Locations (1)

Clinica Nuova ITOR; 🇮🇹 Roma, Italy