Post-Acute Sequelae of SARS-CoV-2 (PASC)

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 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 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 the safety and effectiveness of oral Apabetalone combined with background dapagliflozin treatment for up to 12 weeks in adults with type 2 diabetes mellitus T2DM who have experienced probable or confirmed COVID-19 infection. Participants must have symptoms of Long COVID lasting at least 2 months within 3 months from the start of COVID-19, which cannot be explained by other diagnoses. This phase II, open-label multicentre trial aims to better understand treatment options for this group of patients. Participants will take oral Apabetalone 100 mg capsules twice daily with meals while continuing their daily dapagliflozin 10 mg therapy for diabetes. The study involves seven in-person clinic visits where data will be collected to assess the treatments effects. After screening and consent, eligible participants begin Apabetalone treatment on Day 1 and continue it at home under study supervision. During the trial, participants will undergo various assessments including symptom evaluations and functional status tools related to Long COVID. The primary outcome is the patient acceptable symptom state at 90 days. Secondary measures include fatigue, dyspnea, and post-exertional malaise assessments. Safety and adherence will be monitored throughout, with the total study duration covering treatment and follow-up visits over approximately 12 weeks.

Researchers are investigating why some people experience lasting effects like shortness of breath and fatigue after severe COVID-19 infection. The study focuses on people who had severe COVID-19 requiring hospitalization and those with mild cases who fully recovered. Its goal is to understand the clinical, imaging, immune, molecular, and viral factors linked to long-term lung problems after COVID-19. Participants will visit the Mayo Clinic three times over about a year around 2-3 months, 6 months, and 12 months after their COVID-19 diagnosis. During these visits, they will undergo lung imaging with CT scans, pulmonary function tests, heart electrical activity checks with ECG, and 6-minute walk tests. Bronchoscopies with bronchoalveolar lavages BAL will be done at the first and third visits to collect lung samples. Blood samples will also be collected at all visits to study immune and molecular changes over time. Participants will complete quality of life questionnaires and receive comprehensive clinical evaluations at each visit. Researchers will analyze lung images, lung function, and biological samples to identify markers related to chronic lung conditions post-COVID-19. The study lasts about 12 months per participant, with ongoing monitoring of lung health and symptoms. The main outcome is to uncover traits linked to long-term lung problems following COVID-19 infection.

This observational study evaluates the safety and effectiveness of PAXLOVID in patients at high risk of severe COVID-19 in Korea. It focuses on individuals with mild-to-moderate COVID-19 symptoms who are at increased risk of hospitalization or death. The study aims to observe real-world outcomes rather than results from controlled clinical trials. Participants in this study are those who have received, are currently receiving, or will receive PAXLOVID according to the locally approved label. All treatments follow routine medical practice without any additional interventions or scheduled study visits. The study monitors participants for 28 days after their last PAXLOVID dose to gather safety and effectiveness data. Throughout the study, participants health is observed with no required extra visits. Researchers collect information on adverse events, drug reactions, hospitalizations related to COVID-19, deaths, and changes in COVID-19 symptoms during the follow-up period. The total follow-up lasts up to 33 days from baseline to assess these outcomes in a real-world setting.

Researchers are evaluating the safety and tolerability of Anktiva, an interleukin-15 superagonist called Nogapendekin Alfa Inbakicept, in patients experiencing Long Covid symptoms. This is a Phase 2 clinical trial sponsored by ImmunityBio, Inc. The study focuses on adults aged 18 to 70 who have confirmed Long Covid characterized by specific symptoms lasting at least 60 days and impacting quality of life. Participants will receive up to two subcutaneous doses of N-803 IL-15 Superagonist during the treatment period, which lasts approximately 75 days. All patients are in a single treatment arm. The study includes follow-up visits to monitor safety, collect laboratory tests including blood counts and chemistry, and assess patient-reported outcomes related to health and quality of life. Throughout the study, participants will undergo clinical exams, laboratory assessments such as CBC and CMP, and questionnaires including PROMIS-29 and EuroQoL quality of life measures. Researchers will track adverse events, vital signs, and viral markers in blood and stool over the treatment period and up to 30 days post final dose. The total duration of participation spans around 75 days, with safety and tolerability as the main focus.