Browsing by Author "Le Corre Perez, Monique Nicole"
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- ItemEarly versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial(2021) Balcells Marty, Maria Elvira; Rojas Orellana, Luis Esteban; Martínez Valdebenito, Constanza Pamela; Ceballos Valdivielso, María Elena Andrea; Ferrés Garrido, Marcela Viviana; Chang Rathkamp, Mayling Raquel; Vizcaya Altamirano, María Cecilia; Mondaca Contreras, Sebastián Patricio; Huete Garín, Isidro Álvaro; Castro López, Ricardo Adolfo; Sarmiento Maldonado, Mauricio; Villarroel Del Pino, Luis Antonio; Pizarro Ibáñez, Alejandra Valentina; Ross Pérez, Patricio Daniel; Santander Toro, Jaime Andrés; Lara Hernández, Bárbara Alejandra; Ferrada Koch, Marcela Patricia; Vargas Salas, Sergio Sebastián; Beltrán Pávez, Carolina; Soto Rifo, Ricardo; Valiente Echeverria, Fernando Andrés; Caglevic, Christian; Mahave, Mauricio; Selman Bravo, Carolina Antoniett; Gazitúa, Raimundo; Briones, José Luis; Villarroel Espíndola, Franz; Balmaceda Araque, Carlos Felipe; Espinoza Sepúlveda, Manuel Antonio; Pereira Garces, Jaime; Nervi Nattero, Bruno; Le Corre Perez, Monique NicoleBackground: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression.", "Methods and findings", "The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32-2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19-2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion.", "Conclusions", "In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration.
- ItemIndividualized dose of anti-thymocyte globulin based on weight and pre-transplantation lymphocyte counts in pediatric patients: a single center experience(Springer Nature, 2024) Barriga, Francisco; Wietstruck Pena, Maria Angelica; Schulze Schiappacasse, Clara Edith; Catalan Martinez, Paula Valentina; Sotomayor, Cristian; Zuñiga Contreras, Pamela Alejandra; Aguirre Rioseco, Noemi Doris; Vizcaya Altamirano, Maria Cecilia; Le Corre Perez, Monique Nicole; Villarroel, LuisAnti-thymocyte globulin (ATG) has become a standard in preventing GVHD in related and unrelated donor transplantation, but there is no consensus on the best administration schedule. The PARACHUTE trial reported excellent CD4 immune reconstitution (CD4 IR) using a dosing schedule based on the patient's weight and pre-conditioning absolute lymphocyte count (ALC). In 2015 we introduced the PARACHUTE dosing schedule for pediatric patients at our center. One hundred one patients were transplanted for malignant and non-malignant diseases. In this non-concurrent cohort CD4 IR+, defined by a single CD4 count >50/µL on day 90, was seen in 81% of patients. The incidence of grade II-IV and III to IV aGvHD was 26.6% and 15.3% and 5% for cGvHD with no severe cases. We found no difference in aGvHD between donor type and stem cell sources. Five-year EFS and OS were 77.5% and 83.5%. Grade III-IV GFRS was 75.2%. CD4 IR+ patients had better EFS (93.1% vs. 77.7%, p = 0.04) and lower non-relapse mortality (2.7% vs. 22.2%, p = 0.002). The PARACHUTE ATG dosing schedule individualized by weight and ALC results in good early immune reconstitution, low incidence of cGvHD, and favorable survival for patients with different disease groups, donor types, and stem cell sources.
- ItemSafety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical TrialAbarca Villaseca, Katia; Iturriaga Ortiz, Carolina Alejandra; Urzua, Marcela; Le Corre Perez, Monique Nicole; Pineda Núñez, Augusto Naim; Fernandez Anwandter, Carolina; Domínguez De Landa, María Angelica; González Carbonell, Pablo Andrés; Bueno, Susan M.; Donato, Paulina; Espinoza, Pilar; Fuentes, Daniela; Gonzalez, Marcela; Guzman, Paula; Munoz-Venturelli, Paula; Perez, Carlos M.; Potin, Marcela; Rojas, Alvaro; Gonzalez-Aramundiz, Jose, V; Galvez, Nicolas M. S.; Aguirre-Boza, Francisca; Aljaro, Sofia; Federico Batiz, Luis; Campisto, Yessica; Cepeda, Mariela; Cortes, Aaron; Lopez, Sofia; Loreto Perez, Maria; Schilling, Andrea; Kalergis, Alexis M.Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac (R), an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac (R) in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged >= 60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac (R) is safe, especially in >= 60-year-old participants. Both schedules protected against COVID-19 hospitalization.
- ItemSingle nucleotide variant at the αvβ3 integrin associated to Andes virus infection susceptibility(2018) Martinez Valdebenito, Constanza Pamela; Angulo Troncoso, Jenniffer Alexandra; Le Corre Perez, Monique Nicole; Marco Caceres, Claudia Alejandra; Vial, Cecilia; Miquel Poblete, Juan Francisco; Cerda Lorca, Jaime Rodrigo; Mertz, Gregory; Vial, Pablo; Lopez Lastra, Marcelo Andres; Ferres Garrido Marcela Viviana