Upper Respiratory Infection

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

Researchers are evaluating the safety and immune response of an influenza virus split vaccine in adults aged 60 years and older through a randomized, double-blind, controlled phase I clinical trial. The study includes 120 participants divided into three groups to compare an experimental vaccine dose, a control vaccine dose, and a placebo. This research aims to understand how well the vaccine works and its side effects in this age group. Participants receive one injection of either the experimental influenza vaccine 0.7 mL, a control vaccine 0.5 mL, or a placebo, each administered into the upper arm muscle. Forty individuals are randomly assigned to each group in equal proportions. Laboratory tests are performed before vaccination and on the fourth day after vaccination to monitor immune response and safety. During the study, participants are closely monitored for any side effects for up to 30 days, including both expected and unexpected adverse events. Serious side effects are tracked for six months after vaccination. Researchers measure immune responses 30 days post-vaccination by checking antibody levels and rates of immune reaction. The study involves follow-up visits to assess safety and vaccine effectiveness, with participation lasting several months.

Researchers are conducting a long-term observational study across Europe to understand acute respiratory infections ARI in adults and children visiting primary care. The study aims to describe how ARI presents and is managed in community care, including infections caused by known and emerging respiratory pathogens. This research will help prepare for future clinical trials by building a research-ready infrastructure in primary care settings. Participants in this study may be part of one of three study protocols POS-ARI-PC AUDIT, POS-ARI-PC CORE, or the embedded POS-ARI-PC-001 study. The AUDIT protocol involves anonymous registration of ARI cases presenting at primary care facilities. The CORE protocol includes detailed observational study with patient sampling and 28-day follow-up. The embedded POS-ARI-PC-001 study focuses on older adults or those with long-term health conditions and includes swab collection and follow-up procedures. During participation, patients will complete questionnaires about their symptoms and provide throatnose swabs for analysis. They will be asked to report daily on their health status for up to 14 days using online or paper diaries. Researchers will also review clinical outcomes and hospital referrals up to 28 days after enrollment. Some participants may join optional interviews to share their experiences. The study collects data on illness severity, diagnosis, management, medication use, and return to daily activities to better inform future care and research.

This research aims to develop and test a modified minimally invasive surgical technique for sinus floor augmentation in patients with a residual bone height of 3 to 6 millimeters. The goal is to create a reliable implant bed of at least 10 millimeters in height after a healing period of 3 to 5 months. The study also seeks to reduce patient stress compared to traditional methods. Participants will undergo the sinus floor elevation procedure, which is being evaluated to improve outcomes and comfort. This surgical technique is studied on a pilot group of 12 patients, with no placebo or comparative treatments involved. The procedure targets the maxillary sinus area to enhance bone structure for dental implant placement. During the study, participants will be monitored to measure the height of bone augmentation after 4 to 5 months of healing. The research team will assess the surgical results and patient recovery, including any side effects or complications. The total duration includes the surgery followed by the healing and evaluation period to determine the procedures effectiveness and patient impact.

Researchers are evaluating the LIAISON NES FLU AB, RSV & COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40% possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction RT-PCR to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.

Researchers are evaluating the safety and effectiveness of Onradivir Tablets in adolescents aged 12 to 17 years who have uncomplicated influenza A virus infection. This randomized, double-blind, placebo-controlled Phase III trial aims to compare Onradivir with a placebo to better understand treatment effects during the early stages of influenza A. Participants are randomly assigned in a 21 ratio to receive either Onradivir Tablets at 600 mg once daily or a matching placebo, both taken as 3 tablets per dose for 5 consecutive days. The study includes a screening period, a 5-day treatment period, and a safety follow-up period, with monitoring continuing until Day 14 after the first dose. During the trial, participants will provide nasopharyngeal swabs for viral testing at multiple points including screening and Days 2, 4, 5, and 10. They will also record body temperature, symptom severity, and daily activity using diary cards. Physical exams, vital signs, and lab tests occur at screening, Day 5, and Day 15. Researchers will monitor symptom relief, viral levels, fever resolution, complications, and medication use throughout the study.

Coughing is a common and distressing symptom for people with interstitial lung disease ILD, affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapys impact and participants experiences.

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating the antiviral effects of various treatments in adults aged 18 to 60 with early symptomatic influenza. This phase 2, multi-centre, adaptive platform trial compares several licensed influenza antiviral drugs and others with potential activity against the virus. The study aims to provide clear comparisons of antiviral activity to help guide treatment decisions and policy development. Participants may receive one of several antiviral drugs such as oseltamivir, favipiravir, zanamivir, baloxavir, molnupiravir, peramivir, laninamivir, or combinations of these medications. There is also a control group that receives no antiviral treatment except paracetamol for fever. Dosages and administration routes vary by drug and include oral, inhaled, and intravenous methods. The trial uses randomization to assign treatments, with at least 20% of participants assigned to the no treatment group. During the first five days, researchers will monitor the rate of viral clearance to assess antiviral activity. Additional measures include symptom relief and fever duration over 14 days. Participants will be closely followed up, with assessments including rapid antigen or PCR tests for influenza, symptom tracking, and safety monitoring. The total study period covers initial treatment and observation up to two weeks after starting treatment.

Researchers are evaluating intravenous brincidofovir IV BCV compared to intravenous cidofovir IV CDV for treating adenovirus infection in children and adults who have received allogeneic hematopoietic cell transplants allo-HCT. This Phase 3, multi-center, randomized, open-label study focuses on patients with adenovirus viremia, aiming to assess the effectiveness of these treatments in clearing the virus. The study uses a virologic response-driven approach to determine treatment duration, following ECIL guidelines for high-risk patients. Participants will be randomly assigned to receive either IV BCV or IV CDV. Treatment will continue until adenovirus DNA in plasma is undetectable for two consecutive tests spaced 7 days apart or until a maximum of 12 weeks of therapy is reached, whichever occurs first. Subjects who clear the virus may stop treatment but can be retreated with their assigned drug if adenovirus viremia recurs at defined levels. The study prohibits switching between the two drugs. Safety will be monitored by an independent board during enrollment. Throughout the study, participants will be assessed weekly until the end of treatment, with additional evaluations at 4 weeks after the last dose and at 12 and 24 weeks post-randomization. Researchers will collect plasma samples to measure drug concentrations and monitor viral response and safety. All participants will be followed for a total of 24 weeks regardless of treatment duration, ensuring comprehensive monitoring of efficacy and safety during and after therapy.