Evidence map›Paper›PMID 34306189›Full record

ArticleExperimental and therapeutic medicine2021

Safety and efficacy of a COVID-19 treatment with nebulized and/or intravenous neutral electrolyzed saline combined with usual medical care vs. usual medical care alone: A randomized, open-label, controlled trial.

Ivan Delgado-Enciso, Juan Paz-Garcia, Carlos E Barajas-Saucedo, Karen A Mokay-Ramírez, Carmen Meza-Robles, Rodrigo Lopez-Flores, Marina Delgado-Machuca, Efren Murillo-Zamora, Jose A Toscano-Velazquez, Josuel Delgado-Enciso and 34 more

Open access · diamondAbstract read
In one paragraph

Article in Experimental and therapeutic medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

44 authors at 4 institutions in 1 country.

Ivan Delgado-EncisoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Juan Paz-GarciaDepartment of Internal Medicine and Surgery, Union Hospital Center, Villa de Álvarez, Colima 28970, México.
Carlos E Barajas-SaucedoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Karen A Mokay-RamírezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Carmen Meza-RoblesDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Rodrigo Lopez-FloresDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Marina Delgado-MachucaDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Efren Murillo-ZamoraDepartment of Research, General Hospital of Zone No. 1 and Family Medicine Unit No. 19 IMSS, Villa de Alvarez, Colima 28984, México.
Jose A Toscano-VelazquezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Josuel Delgado-EncisoDepartment of Research, Foundation for Cancer Ethics, Education and Research of the Cancerology State Institute, Colima 28085, México.
Valery MelnikovDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Mireya Walle-GuillenDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Hector R Galvan-SalazarDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Osiris G Delgado-EncisoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Ariana Cabrera-LiconaDepartment of Research, Esteripharma S.A. de C.V., Ciudad de México 03100, México.
Eduardo J Danielewicz-MataCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Pablo J Mandujano-DiazCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
José Guzman-EsquivelDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Daniel A Montes-GalindoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Henry Perez-MartinezCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Jesus M Jimenez-VillegazCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Alejandra E Hernandez-RangelDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Patricia Montes-DiazPrivate Medical Office Xochitepec, Xochitepec, Morelos 62795, México.
Iram P Rodriguez-SanchezLaboratory of Molecular and Structural Physiology, School of Biological Sciences, Universidad Autónoma de Nuevo León, San Nicolas de los Garza, Nuevo León 66455, México.
Margarita L Martinez-FierroMolecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas 98160, México.
Idalia Garza-VelozMolecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas 98160, México.
Daniel Tiburcio-JimenezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Sergio A Zaizar-FregosoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Fidadelfo Gonzalez-AlcarazCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Laydi Gutierrez-GutierrezCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Luciano Diaz-LopezCOVID-19 Respiratory Care Clinic INSABI Poliforum, Tuxtla Gutierrez, Chiapas 29040, México.
Mario Ramirez-FloresDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Hannah P Guzman-SolorzanoDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Gustavo Gaytan-SandovalDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Carlos R Martinez-PerezDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Francisco Espinoza-GómezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Fabián Rojas-LariosDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Michael J Hirsch-MeillonDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Luz M Baltazar-RodriguezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Enrique Barrios-NavarroDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Vladimir Oviedo-RodriguezDepartment of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, México.
Martha A Mendoza-HernandezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Emilio Prieto-Diaz-ChavezDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Brenda A Paz-MichelDepartment of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, México.
Universidad de Colima · MXTuxtla Gutierrez Institute of Technology · MXUniversidad Autónoma de Zacatecas "Francisco García Salinas" · MXUniversidad Autónoma de Nuevo León · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Coronavirus disease 2019 (COVID-19) is currently the major public health problem worldwide. Neutral electrolyzed saline solution that contains reactive chlorine and oxygen species may be an effective therapeutic. In the present study, the treatment efficacy of intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care vs. usual medical care alone was evaluated in ambulatory patients with COVID-19. A prospective, 2-arm, parallel-group, randomized, open-label, multi-center, phase I-II clinical trial including 214 patients was performed. The following two outcomes were evaluated during the 20-day follow-up: i) The number of patients with disease progression; and ii) the patient acceptable symptom state. Serial severe acute respiratory syndrome coronavirus 2 naso/oro-pharyngeal detection by reverse transcription-quantitative (RT-q) PCR was performed in certain patients of the experimental group. Biochemical and hematologic parameters, as well as adverse effects, were also evaluated in the experimental group. The experimental treatment decreased the risk of hospitalization by 89% [adjusted relative risk (RR)=0.11, 95% confidence interval (CI): 0.03-0.37, P<0.001] and the risk of death by 96% (adjusted RR=0.04, 95% CI: 0.01-0.42, P=0.007) and also resulted in an 18-fold higher probability of achieving an acceptable symptom state on day 5 (adjusted RR=18.14, 95% CI: 7.29-45.09, P<0.001), compared with usual medical care alone. Overall, neutral electrolyzed saline solution was better than usual medical care alone. Of the patients analyzed, >50% were negative for the virus as detected by RT-qPCR in naso/oro-pharyngeal samples on day 4, with only a small number of positive patients on day 6. Clinical improvement correlated with a decrease in C-reactive protein, aberrant monocytes and increased lymphocytes and platelets. Cortisol and testosterone levels were also evaluated and a decrease in cortisol levels and an increase in the testosterone-cortisol ratio were observed on days 2 and 4. The experimental treatment produced no serious adverse effects. In conclusion, neutral electrolyzed saline solution markedly reduced the symptomatology and risk of progression in ambulatory patients with COVID-19. The present clinical trial was registered in the Cuban public registry of clinical trials (RPCEC) database (May 5, 2020; no. TX-COVID19: RPCEC00000309).

Indexed as

COVID-19immune systeminflammationneutral electrolyzed salinereactive chlorine speciesreactive oxygen speciesSARS-CoV-2treatment

Identifiers

PMID34306189
PMCPMC8281484
OpenAlexW3176771029

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.