COVID-19 Infection Control Using H2O2 Mouth Wash and Nasa... | NCT04878042

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

NCT04878042

Sponsor

EPISTATA

Status

Withdrawn

Last Update Posted

Nov 23, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

Hydrogen peroxide
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants

Expanded Access Info

Start Date

Apr 9, 2021Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

May 4, 2021

First Submission Date that Met QC Criteria

May 6, 2021

First Posted Date

May 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2022

Last Update Posted Date

Nov 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide	Device: Hydrogen peroxide
Placebo	Placebo Comparator	Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide	Device: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrogen peroxide	Device	Mouth wash and nasal spray 3 times a day for 3 days	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- recent positive SARS-CoV-2 PCER swab test

Exclusion Criteria:

- severe Covid19 disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio I Lazzarino, MD PhD	EPISTATA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Nuova ITOR		Roma			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided