COVID-19

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

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 diseases effects over time.

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, 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 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 bodys 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 1x106 to 1x1010 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 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 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 Paxlovids role in COVID-19 treatment.

Researchers are evaluating the safety and immune response of OCU500, a chimpanzee adenovirus-based COVID-19 vaccine targeting the Omicron XBB1.5 spike protein. This phase 1 trial involves healthy adults aged 18 to 64 who have already completed their primary COVID-19 vaccination series and received at least one booster. The study aims to assess how safe and reactive a single dose of OCU500 is when given to these previously vaccinated adults. Participants are assigned randomly to one of four groups to receive a single dose of OCU500. The vaccine is given either via inhalation or intranasally at two different dose levels 1x1010 or 5x1010 viral particles. Each participant receives only one dose on Day 1. The trial includes 80 participants, with 20 individuals in each group, to compare the effects of the different doses and delivery methods. During the study, participants undergo safety monitoring for adverse events through Day 29 and up to 6 months after vaccination. Researchers also measure immune responses including anti-Spike antibodies in blood and nasal mucosa over 181 days. Participants complete study visits and lab tests to monitor health and immune reactions. The total study duration for each participant extends through 6 months following vaccine administration to evaluate both short- and longer-term safety and immunogenicity.

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.