Covid-19 living Data

Neutral electrolyzed saline vs Standard care (RCT)

Mild outpatients

FOREST PLOTS -2022-04-29

Studies description

Trial RPCEC00000309
Publication Delgado-Enciso I, Exp Ther Med (2021) (published paper)
Dates: 2020-05-01 to 2020-06-30
Funding: Mixed (Consejo Estatal de Ciencia y Tecnología del Estado de Colima; Esteripharma S.A. de C.V.)
Conflict of interest: Yes

Methods
	RCT Blinding:
	Location : Multicenter / Mexico Follow-up duration (days): 20
Inclusion criteria	Men and non-pregnant women ≥18 years of age presenting with COVID-19 and a positive diagnosis of SARS-CoV-2 by RT-PCR that had a medical consultation due to their illness and were indicated for at-home ambulatory treatment.
Exclusion criteria	Pregnant or breastfeeding women and patients presenting with any of the following conditions, prior to the diagnosis of COVID-19: cancer, ischemic heart disease, chronic decompensated systemic disease, creatinine 1.25 times higher than the normal value or creatinine clearance below 50 milliliters/minute (Cockcroft-Gault method), blood hemoglobin below 10 g/dl, drug addiction (illegal drugs), or known liver disease with a doubling of liver function test values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin). Additionally, the following elimination criteria were used: patients that voluntarily decided to abandon the study, patients that, at some point of the study presented with severe toxicity (grade 3 or higher, according to the common terminology criteria for adverse events, CTCAE v5.0, U.S. Department of Health and Human Services), that was attributable to the administration of the experimental drug.
Interventions
	Treatment N-electrolyzed saline 5 mL nebulization 4 times a day for 10 days. IV injections with different doses and frequencies could also be administered.
	Control Standard care
Participants
	Randomized NR Analyzed 214 participants N-electrolyzed saline =110 Standard care=104
	Characteristics of participants N= 214 Mean age : NR 108 males Severity : Mild: n= 214/ Asymptomatic: n=0
Primary outcome
	In the register Disease progression (hospitalization or deaths) until 14th day.
	In the report Number of patients with disease progression (hospitalization or death); Patient Acceptable Symptom State (PASS); change from the baseline in the patient overall self-assessment (score 0-10)
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to available version of the journal and pre-print articles, the study registry was used in data extraction. The study achieved the target sample size (n=100) specified in the registry. There was no change from the trial registration in the intervention and control treatments. Some co-primary outcomes detailed in the report were not specified in the registry (Patient Acceptable Symptom State (PASS) and the change from the baseline in the patient overall self-assessment). The same applies to a secondary outcome stated in the report that was not in the registry, such as changes from the baseline in different types of body pain (arthralgia, myalgia, headache, and sore throat), or more exactly, the difference between the values at enrollment and on days 3, 5, and 7 of follow-up. Pain was measured on the 0–10 VAS. This is the report of data on the effect of the experimental treatment on “Patients treated at home”. Adverse events and viral negative conversion events among the control group were not reported. This trial was updated on September 29th, 2021 with data from the peer-reviewed journal publication.