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NCT04878042 Clinical Trial

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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04878042
Other study ID # 20121617
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 9, 2021
Est. completion date July 2021

Study information
Verified date November 2022
Source EPISTATA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - recent positive SARS-CoV-2 PCER swab test Exclusion Criteria: - severe Covid19 disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hydrogen peroxide
Mouth wash and nasal spray 3 times a day for 3 days
• Placebo
Mouth wash and nasal spray 3 times a day for 3 days

Locations
Country Name City State
Italy Clinica Nuova ITOR Roma

Sponsors (1)
Lead Sponsor Collaborator
EPISTATA

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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