Villahermosa

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years with asthma. This Phase 3, double-blind, randomized, active-controlled, two-period, two-treatment cross-over study focuses on children with asthma who have lung function (FEV1) at or above 50% of the predicted normal value. The study aims to show whether QMF149 is superior to budesonide in improving asthma control. The study lasts up to 37 weeks and includes several phases: a screening period of up to 3 weeks, a 3-week run-in period where all participants receive fluticasone propionate, a first 12-week treatment period with either QMF149 or budesonide delivered once daily via Breezhaler, a 3-week washout period with fluticasone propionate, a second 12-week treatment period where participants switch treatments, and a 4-week safety follow-up where patients return to standard care as appropriate. The treatments are given once daily through an inhaler device. Participants attend scheduled visits every 3 weeks during screening and run-in, every 6 weeks during treatment periods, and a follow-up visit after safety monitoring. Assessments include lung function tests (FEV1), inhaler technique checks, symptom questionnaires, and monitoring of side effects. Researchers evaluate changes from baseline in trough FEV1 after each 12-week treatment to measure lung function. Safety information and survival status are collected at the end of the follow-up period.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating immunity against COVID-19 in healthcare workers (HCW) through a multi-country observational study called EuCARE-HCW. The study collects both past and ongoing data and samples from HCW who have either been vaccinated or had confirmed SARS-CoV-2 infection. The goal is to analyze how different virus variants affect immune response, including how well vaccines and natural immunity protect against these variants. Participants are grouped based on their first known immunization event, which may be vaccination or infection. Follow-up lasts up to 24 months from this event. For those infected naturally, virus variants are identified through swab analysis or inferred from local data. Samples, including serum and whole blood, are collected every four months and sent to central labs for detailed analysis of neutralizing antibodies, cellular immunity, and viral sequences. Throughout the study, HCW provide biological samples and data from 8 countries. Researchers measure immune responses to understand the magnitude, duration, and cross-reactivity against different variants. The primary outcome is the number of HCW involved over an average of three years. The study continuously monitors participants' immunity, contributing valuable information about vaccine and natural infection protection dynamics over time.

Researchers are conducting an observational multicenter study involving hospitalized COVID-19 patients across 12 clinics in 11 countries on 4 continents. The study aims to better understand how different SARS-CoV-2 variants and vaccination schedules affect the clinical course and outcomes of COVID-19. This includes analyzing the impact of viral variants and vaccines on disease severity, treatment responses, and clinical outcomes like mortality and ventilation needs. Patients will receive the standard of care treatment as practiced in each participating hospital. In addition to clinical data collection, biological samples such as peripheral blood and viral isolates are gathered from some patients to study immune responses and viral characteristics. These samples will be analyzed using biostatistics and artificial intelligence to explore links between viral variants, vaccines, and patient outcomes. Participants will be monitored for outcomes including severity of COVID-19 infection, in-hospital mortality, ICU admissions and discharges, and use of mechanical ventilation over an average follow-up of four years. Data and biological materials will support deeper studies on viral behavior and immune responses, aiming to improve clinical management and treatment strategies for hospitalized COVID-19 patients.

Researchers are evaluating the use of local thermotherapy, a treatment that applies heat to the body, in patients with mild-to-moderate COVID-19. COVID-19 is caused by the SARS-CoV-2 virus, an RNA virus responsible for the current pandemic with varying fatality rates worldwide. The study explores thermotherapy as a potential way to reduce viral load by interfering with viral replication, which could help the immune system control and eliminate the infection, especially in high-risk patients. The treatment involves the use of an electric pad placed on the patient's back to provide controlled heat at a temperature of 40-42 °C for two hours. This device, commonly used for muscle pain relief, delivers heat at its lowest intensity level to avoid discomfort. The study applies this thermotherapy mainly as an additional treatment to prevent progression to severe disease. Participants will be monitored for disease progression over 28 days. They will be evaluated for symptoms, oxygen saturation levels, and other clinical signs. Researchers will track the effectiveness of thermotherapy in preventing worsening of COVID-19 and measure safety outcomes. The study includes randomization and follows participants closely during and after the treatment period to assess outcomes and any side effects.

Researchers are studying COVID-19 patients who have recovered from the initial illness to understand how common and what factors predict post COVID-19 condition, which involves symptoms lasting or appearing at least three months after infection. This study is part of the larger EuCARE project involving multiple countries and experts from various fields to explore immunity, long-term outcomes, and control strategies related to COVID-19 and its variants. The study focuses on the natural course and long-term effects of COVID-19, especially the persistence of symptoms and organ damage over an average of three years. Participants will be followed in post COVID-19 outpatient clinics where they will receive routine blood tests and medical evaluations by infectious disease specialists. Depending on their needs, they may also be seen by other specialists such as pulmonologists, cardiologists, neurologists, physiatrists, or psychologists. The study includes both retrospective analysis of previously collected data from patients seen since March 2020 and prospective follow-up of new patients. During their participation, patients will undergo various assessments to monitor symptoms, organ function, and immune responses over time. Researchers will measure the occurrence and persistence of post COVID-19 condition symptoms, long-term damage to lungs, heart, and nervous systems, and study the relationship between viral variants and outcomes. The total follow-up period averages about three years to capture long-term effects and predictors of post COVID-19 condition.