Revisiones para Oropharyngeal sanitization with electrolyzed superoxidation solution with neutral pH to prevent COVID-19 | Registro Público Cubano de Ensayos Clínicos

--- 16 Marzo 2021 - 10:01am por Gladys
+++ 22 Marzo 2021 - 7:46am por lazara
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+/03/22
-/03/16
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Revisión de 22 Marzo 2021 - 7:46am

Oropharyngeal sanitization with electrolyzed superoxidation solution with neutral pH to prevent COVID-19

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

PreveCOVID-19

Scientific title:

Evaluation of the potential in disinfecting or sanitizing the nose and mouth with an electrolyzed superoxidation solution with a neutral pH, as a treatment to reduce or avoid the spread of COVID-19 in health personnel at Hospital Enrique Cabrera during a period of four weeks. (COVID-19)

Acronym of Scientific Title:

PreveCOVID-19

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

General Hospital Dr. Enrique Cabrera Cosio, Mexico.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rafael

Last name:

Gutierrez-Garcia

Medical Specialty :

Otorhinolaryngology

Affiliation:

General Hospital Dr. Enrique Cabrera Cosio, Mexico

Postal address:

Avenue 5 de mayo 3170, Colonia Ex hacienda de Tarango, Alcaldia Alvaro Obregon

City:

Mexico city

País:

Mexico

Zip Code:

01618

Telephone:

+52-5512857100 ext. 5083

Email address:

prosemed@yahoo.com.mx

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

24/09/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Disease Prevention

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Experimental group: Additional to the corresponding protective equipment, they will perform intranasal and oral disinfection with 0.0015%, Neutral Electrolyzed Water (SES). Intranasal disinfection consists of applying four shots of SES in each nostril (approximately 0.4 mL in each nostril), 3 times a day; Oral disinfection will be with mouthwashes that will be performed 3 times a day, with 10 mL of SES, for 60 seconds each. Both procedures will be performed during 4 weeks, which is the study follow-up period. Control group: Will wear the corresponding protective equipment, without performing oral / intranasal disinfection. Protective equipment: All health professionals enrolled in the study belong to the first line of care for patients with COVID-19 and will wear the corresponding protective equipment, being a surgical uniform, N95 mask, eye-sealing glasses and plastic wallet, disposable cap, gloves made of latex, rubber footwear for hospital use, disposable shoe covers. Additionally, health professionals from the third level of care will wear a full protective mask, Dermacare® overalls with 70 / polyethylene and 30 / polypropylene zipper with integrated hood with elastic cuffs and ankle, double disposable boot covers and double latex gloves. Likewise, frequent hand washing with liquid soap with 2% chlorhexidine gluconate and disinfection with a hand sanitizer solution with 0.05% chlorhexidine gluconate and 60-80% ethyl alcohol, and disinfection of secondary uniform and footwear with 80% ethyl alcohol and bath at the end of the working day, were performed.

Intervention code:

Saline Solution

Administration, Oral

Administration, Intranasal

Intervention keyword:

electrolyzed superoxidation solution, mouthwashes

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Absence of symptoms associated with COVID-19 in health professionals on the first line of care of COVID-19 patients (Yes, No). Measurement time: At baseline and, daily over the course of 4 weeks.

Key secondary outcomes:

Adverse effects (oropharyngeal irritation, intolerance to application). Measurement time: At baseline and, throughout the course of the study (four weeks)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

Inclusion criteria:

1. Volunteer health professionals, over 18 years of age and belonging to the first line of care for COVID-19 patients. 2. Health professionals belonging to the Dr. Enrique Cabrera Cosio Hospital. 3. Negative diagnosis for SARS-CoV-2 by PCR. 4. Sign informed consent in writing of the volunteer.

Exclusion criteria:

1. Over 70 years of age. 2. Positive diagnosis for SARS-CoV-2 by PCR. 3. Presence of symptoms compatible with COVID-19. 4. Other pathologies at the discretion of the researcher.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

170

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rafael

Last Name:

Gutierrez-Garcia

Specialty:

Otorhinolaryngology

Affiliation:

General Hospital Dr. Enrique Cabrera Cosio, Mexico

Postal Address:

Avenue 5 de mayo 3170, Colonia Ex hacienda de Tarango, Alcaldia Alvaro Obregon

City:

Mexico city

País:

Mexico

Zip Code:

01618

Telephone:

+52-5512857100 Ext. 5083

Email :

prosemed@yahoo.com.mx

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Brenda

Middle Name:

Astrid

Last Name:

Paz-Michel

Specialty:

Biomedical Research and Chemical Sciences

Affiliation:

Esteripharma SA de CV

Postal Address:

Patricio Sanz 1582, Del Valle, Benito Juarez

City:

Ciudad de Mexico

País:

Mexico

Zip Code:

03100

Telephone:

+52-5550613500

Email :

brendapazmichel@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Research Ethics Committee of the Secretariat of Health of Mexico City (CONBIOETICA-09-CEI-004-20180213)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/08/2020

Postal address of Ethic Committee :

Altadena Num. 23, 2do Piso, Colonia Napoles, ZC:03819, Ciudad de Mexico, Mexico

Telephone:

+52-5132 1200 ext. 1335

Correo electrónico:

ceic.sedesa@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

170

Study completion date:

20/11/2020

Date of available results:

01/04/2021

Date of first publication:

03/05/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000357

Date of Registration in Primary Registry:

16/03/2021

Record Verification Date:

2021/03/22

Next update date:

2022/03/22

Link to the spanish version:

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Oropharyngeal sanitization with electrolyzed superoxidation solution with neutral pH to prevent COVID-19

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