| Autor: |
Delgado-Enciso I; Universidad de Colima Facultad de Medicina., Paz-Garcia J; Centro Hospitalario Unión, Villa de alvarez, colima., Barajas-Saucedo CE; Universidad de Colima Facultad de Medicina., Mokay-Ramírez KA; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Meza-Robles C; Departament of research Cancerology State Institute of Colima., Lopez-Flores R; Departament of research Cancerology State Institute of Colima., Delgado-Machuca M; Departament of research Cancerology State Institute of Colima., Murillo-Zamora E; Departament of research General Hospital of Zone No. 1 IMSS, Villa de alvarez, Colima., Toscano-Velazquez JA; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Delgado-Enciso J; Departament of research Foundation for Cancer Ethics, education and Research of the Cancerology State Institute., Melnikov V; Universidad de Colima Facultad de Medicina., Walle-Guillen M; Universidad de Colima Facultad de Medicina., Galvan-Salazar HR; Departament of research Cancerology State Institute of Colima., Delgado-Enciso OG; Departament of research foundation for Cancer Ethics, Education and Research of the Cancerology State Institute., Cabrera-Licona A; Departament of research, Esteripharma., Guzman-Esquivel J; Departament of research, General Hospital of zone no. 1 IMSS, Villa de Alvarez, Colima., Montes-Galindo DA; Institute of Cancerology: Instituto de Cancerologia., Hemandez-Rangel AE; Universidad de Colima Facultad de Medicina., Montes-Diaz P; Private medical office Xochitepec., Rodriguez-Sanchez IP; Departament of research Hospital of zone no.1 imss Villa de alvarez, Colima., Martinez-Fierro ML; Molecular medicine laboratory: Academic unit of human medicine and health sciences., Garza-Veloz I; Molecular medicine laboratory, Academic unit of Human medicine and health sciences., Tiburcio-Jimenez D; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Zaizar-Fregoso SA; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Ramirez-Flores M; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Gaytan-Sandoval G; Departament of research Cancerology State Institute of Colima., Martinez-Perez CR; Departament of research Cancerology State Institute of Ciolima., Espinoza-Gómez F; Universidad de Colima Facultad de Medicina., Rojas-Larios F; Universidad de Colima Facultad de Medicina., Hirsch-Meillon MJ; Departament of research Cancerology State Institute of Colima., Barrios-Navarro E; Universidad de Colima Facultad de Medicina., Oviedo-Rodriguez V; Departament of research Cancerology State Institute of Colima., Baltazar Rodriguez LM; Universidad de Colima Faculty of Medicine: Universidad de Colima Facultad de Medicina., Paz-Michel BA; Autonomous University of Nueo León. |
| Abstrakt: |
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<0.001). Intravenous + nebulized administration was better than nebulized administration alone, but nebulized administration was better than usual medical care alone. Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets. Cortisol and testosterone levels were also evaluated, observing a decrease in cortisol levels and an increment of testosterone-cortisol ratio, on days 2 and 4. Conclusions: The experimental treatment produced no serious adverse effects. In conclusion, intravenous and/or nebulized neutral electrolyzed saline importantly reduced the symptomatology and risk of progression (hospitalization and death), in ambulatory patients with COVID-19. Trial registration: Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000309. Registered: 05. May 2020. https://rpcec.sld.cu/en/trials/RPCEC00000309-En. |
