Patient-Reported Health Outcomes After Treatment of COVID-19 with Nebulized and/or Intravenous Neutral Electrolyzed Saline Combined with Usual Medical Care Versus Usual Medical care alone: A Randomized, Open-Label, Controlled Trial.

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<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

Neutral Electrolyzed Water (SES) for Nasopharyngeal and Oropharyngeal Rinses Prevented COVID-19 in Front-Line Health Professionals: A Randomized, Open-Label, Controlled Trial in a General Hospital in Mexico City.

“…Additionally, the use of SES by sick people may help to locally inactivate the viral loads in mouth and nose, and thus to reduce the transmission rates. With respect to this point, it has been reported that the administration of SES to ambulatory patients by nebulization, in combination with conventional therapy, reduced the disease progression and improved the signs and symptoms after 24-72 hours of the rst administration [29]. So, this report agrees with the hypothesis of an e cient inactivation of the virus, in the mouth and respiratory tract.…”

Interventions for treatment of COVID-19: second edition of a living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)

“…This trial also showed evidence of a harmful effect of rhG-CSF on non-serious adverse events ( p = 0.0001) [85]. One single trial randomizing 84 participants compared electrolyzed saline versus standard care and showed evidence of a beneficial effect of electrolyzed saline on all-cause mortality ( p = 0.019) [100]. One single trial randomizing 78 participants compared bromhexidine hydrochloride versus standard care and showed evidence of a beneficial effect of bromhexidine hydrochloride on admittance to intensive care ( p = 0.013) and receipt of mechanical ventilation ( p = 0.014) [104].…”

Essentials in saline pharmacology for nasal or respiratory hygiene in times of COVID-19

“…These complex interactions are beyond the scope of this review but have received substantial attention in the context of (severe) COVID-19 [see Supplement 3]. The effects of NaCl on MPO may be clinically relevant in less severe presentations as well, as a pilot study using aerosols of electrolyzed saline (so containing HOCl) proved to be highly ALF alveolar lining fluid, CFTR cystic fibrosis transmembrane conductance regulator, Cl − chloride − HOCl hypochlorous acid, IC 50 inhibitory concentration to inhibit 50%, IC 100 inhibitory concentration to inhibit 100%;MCC mucociliary clearance, MIC minimum inhibitory concentration, MPO myeloperoxidase, Na x sodium channel x, Na + sodium effective in the treatment and viral clearance of SARS-CoV-2 in ambulatory patients with COVID-19 [126].…”