Influenza (Flu)

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.

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.

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 the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo aluminum hydroxide adjuvant injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccines impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are evaluating INNA-051, an intranasal powder designed to boost the innate immune system, to see if it can safely reduce the occurrence, severity, or duration of respiratory viral infections in generally healthy adults aged 18 to 45 who are at risk of exposure due to their living or work environments. This Phase 2a trial focuses on viral respiratory infections, which are a major health concern worldwide and cause significant illness and death. Toll-like receptors targeted by INNA-051 play a key role in the bodys immune defense against viruses. The study has two parts Part A tests the safety and tolerability of INNA-051 when self-administered once weekly for 4 weeks during the respiratory virus season, compared to placebo. Part B evaluates safety, tolerability, and effectiveness over 12 weeks of weekly INNA-051 use in preventing symptoms from laboratory-confirmed respiratory viral infections. Both parts use a randomized, double-blind, placebo-controlled design, with participants using the nasal spray at home. Participants will be monitored through clinical assessments, questionnaires on nasal symptoms, and laboratory tests including blood counts and liver function over the treatment periods and follow-up weeks. In Part B, researchers will track the number of symptomatic infections confirmed by RT-qPCR, symptom severity scores, time to symptom resolution, infection duration, and quality of daily living. Safety is assessed by recording any adverse events throughout the study, which lasts up to 16 weeks depending on the part enrolled.