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: single 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. |
|
| 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 avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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. |