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

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.

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 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 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.

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 treatment's 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 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 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.