ABSTRACT
As lactoferrin is a nutritional supplement with proven antiviral and immunomodulatory abilities, it may be used to improve the clinical course of COVID-19. The clinical efficacy and safety of bovine lactoferrin were evaluated in the LAC randomized double-blind placebo-controlled trial. A total of 218 hospitalized adult patients with moderate-to-severe COVID-19 were randomized to receive 800 mg/die oral bovine lactoferrin (n = 113) or placebo (n = 105), both given in combination with standard COVID-19 therapy. No differences in lactoferrin vs. placebo were observed in the primary outcomes: the proportion of death or intensive care unit admission (risk ratio of 1.06 (95% CI 0.63–1.79)) or proportion of discharge or National Early Warning Score 2 (NEWS2) ≤ 2 within 14 days from enrollment (RR of 0.85 (95% CI 0.70–1.04)). Lactoferrin showed an excellent safety and tolerability profile. Even though bovine lactoferrin is safe and tolerable, our results do not support its use in hospitalized patients with moderate-to-severe COVID-19.
ABSTRACT
As lactoferrin is a nutritional supplement with proven antiviral and immunomodulatory abilities, it may be used to improve the clinical course of COVID-19. The clinical efficacy and safety of bovine lactoferrin were evaluated in the LAC randomized double-blind placebo-controlled trial. A total of 218 hospitalized adult patients with moderate-to-severe COVID-19 were randomized to receive 800 mg/die oral bovine lactoferrin (n = 113) or placebo (n = 105), both given in combination with standard COVID-19 therapy. No differences in lactoferrin vs. placebo were observed in the primary outcomes: the proportion of death or intensive care unit admission (risk ratio of 1.06 (95% CI 0.63-1.79)) or proportion of discharge or National Early Warning Score 2 (NEWS2) ≤ 2 within 14 days from enrollment (RR of 0.85 (95% CI 0.70-1.04)). Lactoferrin showed an excellent safety and tolerability profile. Even though bovine lactoferrin is safe and tolerable, our results do not support its use in hospitalized patients with moderate-to-severe COVID-19.
Subject(s)
COVID-19 , Adult , Humans , Lactoferrin , Double-Blind Method , Antiviral Agents/therapeutic use , Treatment OutcomeABSTRACT
BACKGROUND The role of tracheostomy during the coronavirus disease 2019 (COVID-19) pandemic is still to be determined, and the complication rate of the tracheostomy in COVID-19 patients is still unknown. Postintubation tracheal stenosis is a well-known risk of prolonged endotracheal intubation, but it is too early to define the existence of any difference among the COVID-19 cohort of patients and non-COVID-19 patients. This report is of 2 cases of COVID-19 pneumonia that required tracheostomy and prolonged endotracheal intubation, which were followed by delayed tracheal stenosis. CASE REPORT Case 1. A 54-year-old male was admitted to our hospital (Biella, Italy) for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. The patient underwent orotracheal intubation, progressively improving his breathing function, and was discharged after 20 days. Ten days later, the patient presented with severe respiratory distress. Computed tomography (CT) scan and bronchoscopy showed signs of tracheal stenosis. We administered intravenous steroids for 10 days. The patient showed increasing improvement in his breathing function and was discharged with no other signs of respiratory distress. Case 2. A 43-year-old male was admitted to our hospital for SARS-CoV-2 infection. The patient underwent orotracheal intubation, progressively improving his breathing function, and was discharged after 25 days. Eighteen days later, the patient came to our emergency room with severe respiratory distress. CT scan and bronchoscopy showed signs of tracheal stenosis. The patient had to undergo tracheal resection. CONCLUSIONS The 2 cases presented in this report have shown that even when patients recover from severe COVID-19 pneumonia requiring tracheostomy and mechanical ventilation, tracheal stenosis should be recognized as a potential complication and careful follow-up is required.