Common Cold

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 throat/nose 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 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 drug's 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 safety and tolerability of intravenous brincidofovir (BCV) in adults and children with adenovirus (AdV) or cytomegalovirus (CMV) infections. This Phase IIa, open-label study aims to confirm the effects of multiple ascending doses of BCV in subjects with AdV viremia or CMV, addressing an important need for treatment options in these viral infections. Participants receive BCV through continuous intravenous infusion over 2 hours at doses of 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg twice weekly, or 0.4 mg/kg once weekly for 4 weeks. The study includes four cohorts to assess different dosing regimens and monitors both adenovirus and cytomegalovirus infections. Throughout the study, researchers will monitor safety by tracking adverse events and laboratory tests for up to 19 weeks after starting BCV treatment. They will also evaluate antiviral effects up to 9 weeks. Participants undergo blood sampling for viral load assessments and safety labs. The total participation duration varies depending on follow-up assessments after treatment.

Researchers are evaluating intravenous brincidofovir (BCV) compared to intravenous cidofovir (CDV) for treating adenovirus infection in both adult and pediatric patients who have received allogeneic hematopoietic cell transplantation (allo-HCT). This Phase 3, multi-center, randomized, open-label study focuses on subjects with adenovirus viremia, assessing treatment efficacy and safety. The study follows guidelines for high-risk patients and aims to determine which treatment better clears the virus from the bloodstream. Participants are randomly assigned to receive either IV BCV or IV CDV. Treatment continues until adenovirus DNA is undetectable in plasma for two consecutive tests seven days apart or until a maximum of 12 weeks, whichever happens first. If the virus recurs, subjects may be re-treated with their original assigned drug, but crossover to the other drug is not allowed. Safety is monitored throughout, with an independent board reviewing data to ensure participant safety. During the study, participants undergo weekly assessments until the end of treatment. Additional evaluations occur four weeks after the last dose and at weeks 12 and 24 post-treatment start. The primary outcome is measured at week 5 day 1, with ongoing monitoring of viral levels and safety events through week 24. Subjects remain on study until the final follow-up visit, regardless of treatment duration.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

Researchers are evaluating the safety and effectiveness of a drug called AP1189 in people with respiratory insufficiency expected to be caused by respiratory viral infections such as influenza, respiratory syncytial virus, and coronavirus. This randomized, double-blind, placebo-controlled, multicenter proof-of-concept clinical trial aims to add AP1189 to the standard care and observe its impact compared to a placebo. The study plans to enroll 96 participants and is sponsored by SynAct Pharma Aps. Participants will be randomly assigned to one of two groups: one group receives 100 mg of oral AP1189 once daily for 14 days alongside standard care, while the other group receives a matching placebo under the same conditions. This treatment period lasts for 14 days, and the study is designed to measure outcomes up to 28 days after treatment begins. During the study, participants will undergo various assessments to track their health and response to treatment. Researchers will monitor key outcomes such as death, the need for invasive mechanical ventilation, use of extracorporeal membrane oxygenation (ECMO), cardiovascular organ support, and renal failure up to 28 days from baseline. The study includes hospital assessments and close monitoring to evaluate safety and efficacy, lasting through the treatment and follow-up periods.

Researchers are investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.

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 body's 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.

Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial sponsored by Tasly Pharmaceutical Group Co., Ltd. It aims to assess how well Antiwei granules work and how safe they are in adults aged 18 to 65 with recent onset of common cold symptoms. Participants will be randomly assigned to receive either Antiwei granules or a matching placebo. The treatment involves taking one sachet of granules (6 grams) orally three times a day, for three days. Both groups follow the same dosing schedule, taking nine sachets total. The study compares outcomes between the Antiwei granule group and the placebo group over this short treatment period. Throughout the trial, participants will be closely monitored with assessments focusing on the cure rate after three days of treatment. Researchers will also track symptom recovery time, remission rate, disappearance of individual symptoms, traditional Chinese medicine syndrome efficacy, changes in symptom severity, occurrence of complications, emergency medication use, and overall cure of cough and cold symptoms. The total participation time includes the three-day treatment and monitoring period to evaluate treatment effects and safety.