Work

Efficacy and Safety of Nebulized Sodium Bicarbonate in Adults with COVID-19 (SODIC): A Randomized, Single-Center, Double-Blinded, Controlled Trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Rationale Entry of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into a host cell is pH-dependent. So, intracellular alkalinization by nebulized Sodium Bicarbonate (NSB) could elevate endosomal pH and then block viral entry into the host cells. Objective Study the efficacy of nebulized SB as an adjuvant treatment for COVID-19. Methods A prospective, randomized, double blinded trial conducted in Mansoura University Hospital, Egypt. Eligible patients aged above 18 years old with all COVID-19 severities Patients were electronically randomly assigned (1:1) to receive standard treatment only (control group) (274 patients) or standard treatment plus NSB (272 patients). The primary endpoints were time to clinical improvement defined as number of days from diagnosis until reporting a better feeling by the patients, the length of hospital stay for admitted patients and mortality. This study was registered at ClinicalTrials.gov, NCT05035524 on Sep 2 nd , 2021, and has been completed. Results Between September 2nd, 2021 and April 30th, 2022, 546 patients (215 men and 331 women) were enrolled and randomly allocated for treatment. Mean age was 50·7±16·8 years. Study showed a significantly shorter duration to clinical improvement and hospital stay in the study group (P < 0·001), while the number of deaths is significantly less only in the severe grade of the study group (11 cases in the study group versus 22 cases in the control group, p = 0·014). CRP and d-dimer levels measured at one week are significantly lower in the severe cases of the study group (p = 0·001). The overall median CT score is significantly better in the study group at all points of follow-up (p < 0·05). All patients reported mild irritative cough initially with SB inhalation. No serious treatment adverse events were observed. Interpretation NSB (8·4%) could be a possible adjuvant therapy for patients with moderate and severe COVID‑19.

Source: Current Therapeutic Research

DOI: 10.1016/j.curtheres.2025.100801