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
Neutral electrolyzed saline 5 mL nebulization 4 times a day for 10 days. IV injections with different doses and frequencies could also be administered. |
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| Control
Standard care Definition of Standard care: The patients receiving only usual medical care continued with the usual treatment prescribed by their family physician or specialist. Usual care is the care the targeted patient population would be expected to receive as part of normal practice (42). This is a valid strategy as a reference treatment in clinical trials, including various therapy trials against COVID‑19 (43‑45). It consisted of the administration of paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, azithromycin, chloroquine, ivermectin, and/or antiviral drugs, etc., with the indication to return to the emergency service if there was respiratory difficulty or worsening of symptomatology. The researchers did not intervene in drug prescription or lifestyle indications (usual medical care). | |
| Participants | |
| Randomized * participants (n1=* / n2= *) | |
| Characteristics of participants N=* Mean age : NR 108 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: 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 available |
Protocol NR Statistical plan NR Data-sharing stated
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| 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 |
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| General comment |