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Determination of the Effectiveness of Oral Chlorine Dioxide in the Treatment of COVID 19

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ClinicalTrials.gov Identifier: NCT04343742
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Eduardo Insignares Carrione, Genesis Foundation

Brief Summary:

Abstract The objective of this study is to review, through prospective case research, the efficacy of oral chlorine dioxide in the treatment of patients with COVID infection 19. The research will be carried out between April and June 2020 with a quasi-experimental design in two health care centers on a sample of twenty (20) patients, through direct intervention, who will measure the changes in the manifest symptoms of infection and negativity. a COVID 19 after administration of the study preparation, to determine the effectiveness of chlorine dioxide in the treated group.

Based on the results that are found and on the evaluation of efficacy on the basis of clinical improvement on a scale of 1 to 5, and of the negativization of COVID 19, we can conclude whether the therapeutic efficacy in this investigation is considered good by verifying whether or not there is efficacy of treatment with chlorine dioxide in COVID 19.

With this research, it is hoped to stimulate the search for new therapeutic options in the treatment of COVID 19 and contribute to the development of NEW options in medications, considering the immense number of deaths and morbidity that currently exists in the present pandemic.

Key words: COVID 19, chlorine dioxide, treatment.


Condition or disease Intervention/treatment
COVID-19 Drug: chlorine dioxide 3000 ppm

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of the Effectiveness of Oral Chlorine Dioxide in the Treatment of COVID 19
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : April 7, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
chlorine dioxide 3000 ppm. Bottle x 150 cc.

Assignment of study medication Each patient will receive, in order of admission to the study, a consecutive patient number and the corresponding study medication. The assignment of this medication was made before the start of the study, using a computer generated list. Patients will receive the 3,000 ppm chlorine dioxide base preparation with written and precise instructions on how to prepare and take the dilutions.

7.1 Dosage and route of administration. Medication: chlorine dioxide 3000 ppm. Fco x 150 cc. 10 ml of 3000 ppm chlorine dioxide are added to 1 liter of water, per day. One part is taken every hour, until the content of the bottle is finished (8 to 12 shots).

Both the original dioxide bottle and the preparation for the day should be kept refrigerated.

Drug: chlorine dioxide 3000 ppm

Each patient will receive the 3,000 ppm chlorine dioxide base preparation with written and precise instructions on how to prepare and take the dilutions.

: 10 ml of 3000 ppm chlorine dioxide are added to 1 liter of water, per day. One part is taken every hour, until the content of the bottle is finished (8 to 12 shots).





Primary Outcome Measures :
  1. negative testing of covid19 [ Time Frame: 7 DAYS ]
    amplification of coronavirus genes by RT-PCR



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population to which the study was directed consisted of a group of patients of medical and health profession with active infection with COVID-19, from various medical care centers, hospitals, in the city of Bogotá, Colombia and Madrid, Spain (multicenter .) The selection of the patients was made based on the self-proposal of the doctors / patients as candidates for research, which refers to the fact that they proposed themselves as cases. Similarly, simultaneity was applied, which means that the patients were obtained in the same period of time in which the cases arose.
Criteria

Inclusion Criteria:

- to. Covid 19 positives b. Some of the characteristic symptoms of covid 19: fever, odynophagia, respiratory distress.

c. Age between 18 years and 80 years

Criteria Exclusion:

  • to. Covid 19 negatives b. Kidney failure IV / VI. c. Congestive heart failure. d. Patients taking anticoagulants, particularly warfarin sodium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343742


Contacts
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Contact: EDUARDO INSIGNARES-CARRIONE, Research Direc. +573007191994 eduardoinsignarescarrione@gmail.com
Contact: BLANCA BOLANO, researcherer +573107970227 blancambolanog@hotmail.com

Locations
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Colombia
Hospital Fhsj Recruiting
Bogota, Cundinamarca, Colombia
Contact: YOHANY ANDRADE    3012629694    yohannyandrade2@gmail.com   
San Carlos Hospital Recruiting
Bogota, Cundinamarca, Colombia
Contact: YOHANNY ANDRADE, INVESTIGATOR    +573012629694    yohanny.andrade2@gmail.com   
Sponsors and Collaborators
Genesis Foundation
Investigators
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Study Chair: yohanny andrade, researcher Genesis Foundation
Study Chair: oswaldo leyva, researcher Genesis Foundation
Publications of Results:
Other Publications:
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Responsible Party: Eduardo Insignares Carrione, research director, Genesis Foundation
ClinicalTrials.gov Identifier: NCT04343742    
Other Study ID Numbers: Genesis AKCOVID- FG-1
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorine dioxide
Dental Disinfectants
Disinfectants
Anti-Infective Agents