NCT04343742

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

6 days

First QC Date

April 7, 2020

Last Update Submit

May 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • negative testing of covid19

    amplification of coronavirus genes by RT-PCR

    7 DAYS

Study Arms (1)

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

Interventions

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).

chlorine dioxide 3000 ppm. Bottle x 150 cc.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Fhsj

Bogota, Cundinamarca, Colombia

RECRUITING

San Carlos Hospital

Bogota, Cundinamarca, Colombia

RECRUITING

Related Publications (5)

  • Schijven J, Teunis P, Suylen T, Ketelaars H, Hornstra L, Rutjes S. QMRA of adenovirus in drinking water at a drinking water treatment plant using UV and chlorine dioxide disinfection. Water Res. 2019 Jul 1;158:34-45. doi: 10.1016/j.watres.2019.03.090. Epub 2019 Apr 1.

    PMID: 31015141BACKGROUND
  • Kingsley DH, Perez-Perez RE, Niemira BA, Fan X. Evaluation of gaseous chlorine dioxide for the inactivation of Tulane virus on blueberries. Int J Food Microbiol. 2018 May 20;273:28-32. doi: 10.1016/j.ijfoodmicro.2018.01.024. Epub 2018 Feb 1.

    PMID: 29558681BACKGROUND
  • Montazeri N, Manuel C, Moorman E, Khatiwada JR, Williams LL, Jaykus LA. Virucidal Activity of Fogged Chlorine Dioxide- and Hydrogen Peroxide-Based Disinfectants against Human Norovirus and Its Surrogate, Feline Calicivirus, on Hard-to-Reach Surfaces. Front Microbiol. 2017 Jun 8;8:1031. doi: 10.3389/fmicb.2017.01031. eCollection 2017.

    PMID: 28642746BACKGROUND
  • Ma JW, Huang BS, Hsu CW, Peng CW, Cheng ML, Kao JY, Way TD, Yin HC, Wang SS. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution. Int J Environ Res Public Health. 2017 Mar 22;14(3):329. doi: 10.3390/ijerph14030329.

    PMID: 28327506BACKGROUND
  • Zhu Z, Guo Y, Yu P, Wang X, Zhang X, Dong W, Liu X, Guo C. Chlorine dioxide inhibits the replication of porcine reproductive and respiratory syndrome virus by blocking viral attachment. Infect Genet Evol. 2019 Jan;67:78-87. doi: 10.1016/j.meegid.2018.11.002. Epub 2018 Nov 3.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • yohanny andrade, researcher

    Genesis Foundation

    STUDY CHAIR
  • oswaldo leyva, researcher

    Genesis Foundation

    STUDY CHAIR

Central Study Contacts

EDUARDO INSIGNARES-CARRIONE, Research Direc.

CONTACT

BLANCA BOLANO, researcherer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research director

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 13, 2020

Study Start

April 1, 2020

Primary Completion

April 7, 2020

Study Completion

June 1, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations