1. 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
- Author
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Michael J. Hirsch-Meillon, Mario Ramírez-Flores, Martha A. Mendoza-Hernandez, Sergio A Zaizar-Fregoso, Luz M. Baltazar-Rodriguez, Iram P. Rodriguez-Sanchez, José Guzmán-Esquivel, Carlos E Barajas-Saucedo, Gustavo Gaytan-Sandoval, Eduardo J. Danielewicz-Mata, Emilio Prieto-Díaz-Chávez, Efrén Murillo-Zamora, Hannah P. Guzman-Solorzano, Fabian Rojas-Larios, Francisco Espinoza-Gómez, Enrique Barrios-Navarro, Valery Melnikov, Laydi Gutierrez-Gutierrez, Pablo J. Mandujano-Diaz, Alejandra E. Hernandez-Rangel, Hector R Galvan-Salazar, Karen A Mokay-Ramírez, Marina Delgado-Machuca, Juan Paz-Garcia, Rodrigo Lopez-Flores, Idalia Garza-Veloz, Fidadelfo Gonzalez-Alcaraz, Jose A. Toscano-Velazquez, Jesus M. Jimenez-Villegaz, Margarita L Martinez-Fierro, Brenda Paz-Michel, Patricia Montes-Diaz, Carlos R. Martinez-Perez, Daniel A. Montes-Galindo, Henry Perez-Martinez, Daniel Tiburcio-Jimenez, Luciano Diaz-Lopez, Carmen Meza-Robles, Ivan Delgado-Enciso, Mireya Walle-Guillen, Osiris G Delgado-Enciso, Josuel Delgado-Enciso, Vladimir Oviedo-Rodriguez, and Ariana Cabrera-Licona
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Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Article ,law.invention ,Immunology and Microbiology (miscellaneous) ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Adverse effect ,Saline ,reactive oxygen species ,treatment ,business.industry ,SARS-CoV-2 ,Cancer ,COVID-19 ,General Medicine ,Articles ,reactive chlorine species ,medicine.disease ,Confidence interval ,Clinical trial ,immune system ,inflammation ,Relative risk ,Ambulatory ,business ,neutral electrolyzed saline - Abstract
Background: Coronavirus disease (COVID-19) is currently the main public health problem worldwide. The administration of neutral electrolyzed saline, a solution that contains reactive species of chlorine and oxygen (ROS), may be an effective therapeutic alternative due to its immunomodulating characteristics, in systemic inflammation control, as well as in immune response improvement, promoting control of the viral infection. The present study evaluated the efficacy of treatment with intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care versus usual medical care alone, in ambulatory patients with COVID-19. Methods: A prospective, 2-arm, parallel group, randomized, open-label, phase I-II clinical trial included 39 patients in the control group (usual medical care alone) and 45 patients in the experimental group (usual medical care + intravenous and/or nebulized electrolyzed saline, with dose escalation). Two aspects were evaluated during the twenty-day follow-up: i) the number of patients with disease progression (hospitalization or death); and ii) the Patient Acceptable Symptom State (PASS), a single-question outcome that determines patient well-being thresholds for pain and function. Biochemical and hematologic parameters, as well as adverse effects, were evaluated in the experimental group. Results: The experimental treatment decreased the risk for hospitalization by 92% (adjusted RR=0.08, 95% CI: 0.01–0.50, P=0.007), with a 43-fold increase in the probability of achieving an acceptable symptom state on day 5 (adjusted RR= 42.96, 95% CI: 9.22–200.0, P
- Published
- 2021