Browsing by Author "Perez-Mateluna, Guillermo"

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    Safety, Tolerability, Bioavailability, and Biological Activity of Inhaled Interferon-& alpha;2b in Healthy Adults: The (INCOVID)-C-2 Phase I Randomized Trial
    (2023) García-Huidobro Munita, Diego Nicolás; Iturriaga, Carolina; Perez-Mateluna, Guillermo; Fajuri, Paula; Severino Cuevas, Nicolás Felipe; Urzua, Marcela; Fraga, Juan Pablo; Cruz, Javiera de la; Poli, Cecilia; Castro Rodríguez, José Antonio; Fish, Eleanor; Borzutzky, Arturo
    Background and ObjectivesInterferons have been identified as a potential treatment alternative for coronavirus disease 2019. This study assessed the safety, tolerability, bioavailability, and biological activity of inhaled interferon-& alpha;2b (IFN)-& alpha;2b in healthy adults.MethodsA double-blind, randomized, phase I clinical trial was conducted with two cohorts of healthy subjects aged 18-50 years. The first cohort received 2.5 MIU of inhaled IFN-& alpha;2b twice daily for 10 days (n = 6) or placebo (n = 3); the second cohort received 5.0 MIU of inhaled IFN-& alpha;2b in a similar scheme (n = 6) or placebo (n = 3). The first two doses were administered in an emergency department, then participants completed their treatment at home. Safety was measured through vital signs, new symptoms, and laboratory tests. Tolerability was measured as participants' treatment acceptability. Bioavailability and biological activity were measured from serum IFN & alpha; concentrations and real-time quantitative polymerase chain reaction of interferon-induced genes in blood before and after treatments.ResultsExposure to inhaled IFN-& alpha;2b at 2.5-MIU or 5-MIU doses did not produce statistically significant changes in participant vital signs, or elicit new symptoms, and standard hematological and biochemical blood measurements were comparable to those recorded in individuals who received placebo. A total of 58 adverse events were observed. All were mild or moderate and did not require medical care. All participants reported very high tolerability towards a twice-daily nebulized treatment for 10 days (98.0, 97.0, and 97.0 in the placebo, 2.5-MIU, and 5-MIU groups, respectively, on a 0- to 100-mm visual analog scale). A dose-dependent mild increase in serum IFN-& alpha; concentrations and an increase in serum RNA expression of IFN-induced genes were observed 11 days after treatment (p < 0.05 for all between-group comparisons).ConclusionsInhaled IFN-& alpha;2b was preliminarily safe and well tolerated, and induced systemic biological activity in healthy subjects.
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    Weekly Vitamin D Supplementation to Prevent Acute Respiratory Infections in Young Children at Different Latitudes: A Randomized Controlled Trial
    (2024) Reyes, Maria Loreto; Vizcaya, Cecilia; Le Roy, Catalina; Loureiro, Carolina; Brinkmann, Karin; Campos, Laura; Arancibia, Monica; Iturriaga, Carolina; Perez-Mateluna, Guillermo; Rojas-McKenzie, Maite; Dominguez, Gonzalo; Camargo Jr, Carlos A.; Borzutzky, Arturo
    Objective: To evaluate the effectiveness of weekly vitamin D supplementation in reducing the number of acute respiratory infections (ARI) in preschool children. Study design: Randomized, double-blind, placebo-controlled trial in 303 children aged 1.5-3.5 years from 2014 to 2105 in 3 Chilean cities at different latitudes: Santiago (33 degrees S, n = 101), Talcahuano (37 degrees S, n = 103), and Punta Arenas (53 degrees S, n = 99). Participants were allocated (1:1:1) to receive placebo, cholecalciferol (vitamin D3 (VD3)) 5600 IU/week (low-dose), or 11 200 IU/week (high-dose) for 6 months. Primary outcome was parent-reported number of ARI; secondary outcomes included number of ARI hospitalizations, change of serum 25-hydroxyvitamin D (25(OH)D) and LL-37/cathelicidin levels, and adverse events. Results: The mean age of participants was 26 +/- 6 months; 45% were female. Baseline 25(OH)D was 24.9 +/- 6.1 ng/ml, with 23% having 25(OH)D <20 ng/ml. No significant baseline clinical or laboratory differences were observed among groups. Overall, 64% (n = 194) completed study participation, without baseline differences between subjects lost to follow-up vs those completing participation or differences in completion rates across groups. After 6 months, a dose-dependent increase in serum 25(OH)D was observed from the VD3 intervention (P < .001), with a higher proportion of subjects ending the trial with 25(OH)D <20 ng/ml in the placebo group (30.8%) vs the low-dose (7.4%) and high-dose groups (5.1%). However, no group differences were observed in number of ARI (P = .85), ARI hospitalizations (P = .20), LL-37/cathelicidin change (P = .30), or adverse events (P = .41). Conclusions: While weekly VD3 supplementation, in doses equivalent to 800 IU and 1600 IU daily, was associated with improved 25(OH)D levels in preschoolers, we did not find a reduced number of ARI in this sample.