COVID-19

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are conducting a long-term observational study to understand the characteristics and outcomes of people infected with the Omicron variant of COVID-19, including those without symptoms and those diagnosed with the disease. The study aims to explore how the virus affects various organs like the heart and lungs and to monitor changes in social and psychological health over time. Participants in this study are individuals who have tested positive for SARS-CoV-2 RNA. The study involves a follow-up period extending up to 10 years, during which participants' health status is observed without any specific treatment interventions. This extended observation allows researchers to gather detailed information on the progression and long-term impact of COVID-19. Throughout the study, participants will be monitored for changes in their clinical conditions and social and psychological well-being. The main focus is on assessing long-term outcomes and shifts in health characteristics over a decade. Data will be collected regularly to track these aspects, helping to provide a comprehensive understanding of the disease's effects over time.

Researchers are evaluating the LIAISON NES FLU A/B, 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.

This research focuses on caregivers in the Bronx who are experiencing increased psychological distress due to the COVID-19 pandemic and related social challenges. It aims to evaluate how the CARE program and the Valera Health app can reduce this distress, improve access to healthcare, and support vulnerable caregivers, including those of children with psychiatric or autoimmune conditions and frontline healthcare workers. The study is a randomized controlled trial designed to assess these interventions' effects on caregiver stress, mood, anxiety, and healthcare engagement. Participants will be randomly assigned to one of three groups: the CARE program alone, the Valera Health app alone, or a combination of both. The CARE program involves 12 weekly one-hour group sessions lasting 12 weeks, while the Valera Health app offers parent education materials and connection to their child's treatment team. Smartphones and internet connectivity will be provided if needed to support participation. During the 24-week study period, caregivers will complete surveys at enrollment, 6 weeks, 12 weeks, and 24 weeks to measure perceived stress, reflective functioning, mood, anxiety, suicidality, and healthcare access. The study also explores how providing technology affects outcomes and uses machine learning to analyze various personal and social factors. The trial includes follow-ups and ongoing monitoring to understand the interventions' impact over time.

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 two investigational COVID-19 booster vaccines called CoTend-s3BXBB and CoTend-BXBB in healthy adults aged 40 to 64. The CoTend-s3BXBB vaccine includes a component named "s3" designed to enhance the body's immune response, while CoTend-BXBB is the same vaccine without this component. The study aims to determine if the vaccines are safe and whether the "s3" component generates a stronger, broader, and longer-lasting immune response. Participants will receive a single injection of one of the vaccines at varying doses, or a placebo. The vaccines are delivered as intramuscular shots, with doses ranging from 1x10^6 to 1x10^10 viral particles in a 0.5 mL volume. There are multiple study groups receiving different doses of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be randomly assigned to these groups in a blinded manner. During the study, participants will be closely monitored for any side effects for up to 28 days after dosing and for serious events through longer follow-up visits up to 104 weeks. Samples of saliva, nasal secretions, and blood will be collected to measure immune responses, including antibody levels and T cell responses, through various timepoints up to two years. Safety assessments include tracking local and systemic reactions, adverse events, and medically attended issues.

Researchers are evaluating the use of Astepro4 0.15% nasal spray to manage early SARS-CoV-2 infection in vaccinated adults. This pilot clinical trial aims to confirm whether this medication can reduce viral load, lessen symptoms, lower infectivity, and improve quality of life in people recently diagnosed with mild Covid-19. The study is conducted at the University of Chicago and involves participants who test positive by home antigen or PCR tests. Participants will be randomly assigned to receive either the Astepro nasal spray or a placebo, both provided with instructions for proper use. The study is double-blind, meaning neither participants nor researchers know who receives the medication or placebo. Treatment follows standard dosing for allergic rhinitis, and supportive care recommendations are standardized for all. If severe disease develops, participants will be guided on how to seek further care. During the study, participants will provide saliva samples every other day over a 10-day period to measure viral load and report symptoms using validated surveys. Researchers will also collect data on side effects, patient satisfaction, and tolerability through contactless methods. The primary outcome focuses on viral load changes from baseline to day 10, while secondary outcomes evaluate infectivity rates among close contacts and changes in respiratory symptoms and quality of life.

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 studying how well and how safely Paxlovid works for treating patients hospitalized with COVID-19. This real-world study collects medical records from patients visiting Huashan Hospital affiliated to Fudan University between 2022 and 2027. The research aims to understand the effects of Paxlovid and factors that may influence the outcomes for COVID-19 patients. The study compares two groups: patients receiving Paxlovid therapy and those receiving routine therapy without Paxlovid. The exact use of Paxlovid is based on patients' medical history as recorded in their treatment. Data on demographics, clinical features, lab tests, treatment history, adverse reactions, and treatment results will be gathered and analyzed. Participants will have their viral shedding time and disease progression tracked for up to 28 days. Researchers will also monitor adverse events and recovery times. Data on how many patients test negative for the virus and their clinical recovery will be measured. The study collects information from medical records without altering patients’ usual care, and results will help understand Paxlovid's role in COVID-19 treatment.

Researchers are evaluating the safety and immune response of OCU500, a new COVID-19 vaccine using a chimpanzee adenovirus vector to deliver the Omicron XBB1.5 spike protein. This phase 1 open-label trial involves healthy adults aged 18 to 64 who have completed their primary COVID-19 vaccination series and received at least one booster. The study aims to assess how well the vaccine is tolerated and its ability to stimulate immune protection in previously vaccinated individuals. The trial tests two dose levels of OCU500 (1x10^10 and 5x10^10 viral particles) delivered either intranasally or by inhalation. Participants are randomly assigned to one of four groups, each receiving a single dose of the vaccine on Day 1. There are 80 participants in total, with 20 in each group. The study is carefully monitoring safety and immune responses over time. Participants will attend study visits for up to six months after vaccination. Researchers will collect blood and nasal samples to measure antibody responses, including IgA and IgG levels against the spike protein. They will also record any adverse events, including local and systemic reactions, serious side effects, and new medical conditions. Safety labs and clinical assessments will be done through Day 8 and follow-up continues through Day 181. The study includes tests to track immune responses to the vaccine vector and overall immune stimulation.