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.
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:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
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.
Affiliation:
General Hospital Dr. Enrique Cabrera Cosio, Mexico
Postal address:
Avenue 5 de mayo 3170, Colonia Ex hacienda de Tarango, Alcaldia Alvaro Obregon
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:
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
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:
Health condition(s) code:
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Nidovirales Infections
Betacoronavirus
Disease Prevention
Health condition keyword:
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.
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.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Randomized controlled trial
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
Affiliation:
General Hospital Dr. Enrique Cabrera Cosio, Mexico
Postal Address:
Avenue 5 de mayo 3170, Colonia Ex hacienda de Tarango, Alcaldia Alvaro Obregon
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.
Specialty:
Biomedical Research and Chemical Sciences
Postal Address:
Patricio Sanz 1582, Del Valle, Benito Juarez
Data Sharing Section to complete the data related to the data sharing plan.
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 date of Ethic Committee:
Postal address of Ethic Committee :
Altadena Num. 23, 2do Piso, Colonia Napoles, ZC:03819, Ciudad de Mexico, Mexico
About study completion Section to complete the data related to the study completion.
Results Study Section to complete the data related to the summarized results.
Summary study:
Beef is an excellent source of nutrients; unfortunately, most nutritional recommendations suggest limiting or even avoiding it. Studies have shown that the fatty acid composition of meat influences weight loss. This randomized controlled clinical trial evaluated the anthropometric and serum lipid changes after a food intervention that included frequent beef consumption (120 g consumed four days/week for four weeks). Volunteers were randomly assigned to the commercial or Wagyu-Cross beef groups, with the latter beef possessing higher fat and MUFA contents. Both groups exhibited reductions in body measurements and lipid profiles; however, the Wagyu-Cross group exhibited greater changes in weight (−3.75 vs. −2.90 kg) and BMI (−1.49 vs. −1.03) than the commercial group, without a significant difference between them. No significant group differences in lipid profiles were observed; however, the Wagyu-Cross group exhibited a more favorable change in decreasing the TC concentration (−7.00 mg/dL) and LDL-C concentration (−12.5 mg/dL). We suggest that high MUFA beef could be included in weight-loss programs since it does not affect weight loss and hasn’t a negative influence on lipid metabolism.
Url for Results File:
https://www.spandidos-publications.com/10.3892/br.2021.1494
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
