803 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.
The present study aims to investigate the safety and immunogenicity of the Novavax JN.1 subvariant vaccine SARS-CoV-2 rS adjuvanted with Matrix-M (NVX CoV2705) in previously vaccinated adults. A descriptive comparison will be made with participants who received the prior authorized vaccine NVX-CoV2601 in an earlier study (2019nCoV-313).
The Coronavirus Disease of 2019 (COVID-19) pandemic has caused an international healthcare crisis and produced a large healthcare burden. Diabetes mellitus is a common disease that can be controlled via pharmacologic agents; however, many patients have poor glycemic control, leading to disease-related complications. Diabetes mellitus has been reported in the literature to be associated with increasing morbidity and mortality in COVID-19 patients, and some hypothesize that this is due to insulin dysregulation propagating a pro-inflammatory state. The investigators aim to contribute to the growing body of literature that assesses the associations between glucose homeostasis and COVID-19 disease severity and mortality.
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.
This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.
The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: * Have completed treatment with nirmatrelvir/ritonavir * Have a rebound in COVID-19 symptoms * Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.
The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to: * Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration * Characterize the immunogenicity of casirivimab and imdevimab in serum over time
The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 years of age with body mass index ≤35 kg/m\^2. Prior studies examined IV administration, and the secondary objective of the present study was to compare PK among the three administration routes. No placebo group was included in the phase 1 randomized design. The exploratory objective was to evaluate disease severity in participants that became positive for SARS-CoV-2.
The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
The primary objectives of the study are: * To characterize the concentrations of casirivimab+imdevimab in serum over time * To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: • To assess the immunogenicity of casirivimab+imdevimab
Clinical trials of prevention modalities for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and coronavirus disease (COVID-19) and pneumonia are underway under separate protocol(s) for close contacts (i.e., household contacts, \[e.g.,3502\]) of infectious (index) individuals (3502-01). Characterizing the index individuals within households will ascertain the risk of exposure for the contact participant. These data will be used to strengthen the precision of efficacy estimates. This ancillary observational study will assess the cofactors for infectiousness among index individuals whose close contacts are enrolled in COVID-19 prevention clinical trials. Additionally, this study will assess post-acute sequelae of SARS-CoV-2 infection in index individuals that are more than two weeks past their initial diagnosis.
The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration The secondary objectives of the study are: * To assess the safety and tolerability of SC or single administration of casirivimab+imdevimab * To assess the occurrence of grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC doses of casirivimab+imdevimab * To assess the immunogenicity of casirivimab+imdevimab
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
The two-part phases will each have a unique patient population, The goal in this application is to see if that carotid bodies are "offline" is correct and to determine whether a cohort of SARS-Cov-2 patients can be identified who fit this profile and would be suitable for drug treatment. The testing will require one group of subjects to hold their breaths for a short period while the investigators monitor vital signs and blood O2 levels. A second group of "healthier" COVID subjects will be asked perform a walk-test inside their rooms for six minutes while vital signs are monitored as well as blood O2 levels. If the subjects are in the healthy control group, they will perform the walk test in a designated hallway at the medical center also while there vitals are being monitored. The goal, using a mild stimulus, is to determine whether respiration increases if blood O2 saturation is decreased. If it does not, that would indicate a failure of the carotid body oxygen sensing system.
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.
Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.
The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as point of care (POC) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.
The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo. The secondary objectives of the study are: * To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time * To assess the immunogenicity of REGN10933 and REGN10987
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois. Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled. Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks. There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.
The primary objectives of this study are: * To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and * To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19
The primary objectives are: * To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: * To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo * To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration * To assess the immunogenicity of REGN10933 and REGN10987
The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 300 people who had COVID-19 based on lab testing or confirmed exposure to participate. An additional 25 participants who have never tested positive for COVID and have not had the vaccine will be enrolled as negative controls. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 12 times over 24 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.
The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) * To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Phase 1 * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 * Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death * Cohort 2 (\<18 Years Old, Not Pregnant at Randomization) * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To further characterize the concentrations of REGN10933 and REGN10987 in serum over time * Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987
Background: Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples. Objective: To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front part of the nostril only, or a saliva sample plus a nasal swab gives results that are as accurate as the NP swab. Eligibility: NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance. Design: The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP swab is collected by OMS. If their NP swab was already collected, their OMS record will be reviewed for the result. If the NP swab result is positive, the participant will have another NP swab. At that time, they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have an NP swab. For the saliva sample, participants will spit into a tube. For the nasal swab, the inside of the front part of the nostril will be swabbed. Participation ends after the study samples are collected. Participants can choose to keep giving saliva and nasal swab samples each time they have an NP swab.
In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine Zero (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10-20ml (according to the rinse instructions) of the assigned solutions 4 times per day, for 30-60 seconds, for 4 weeks.
This study is designed to evaluate a potential mechanism by which a hyperactive immune response may contribute to death from SARS-CoV-2; by an excessive neutrophil-mediated deposition of cell-free DNA in neutrophil extracellular traps (NET). Excessive amounts of NETs can increase rigidity of mucus, clog airways, and be agents for the development of acute respiratory distress (Narasaraju et al., Am J Pathol. 2011). Many aspects of this pathway have been observed in severe SARS-CoV-2 (Zhang et al., Respiratory research. 2020). Dornase alfa (DNAse I; Pulmozyme (Genentech) is a nebulized drug that works by degrading cell-free DNA and thus promoting airway clearance and recovery. The investigators hypothesize that by thinning mucus and degrading these NETs further lung damage may be prevented and a reduction in time to recovery may occur. The two aims of the study are to see if inhaled/nebulized dornase alfa will improve clinical outcome measures in SARS-CoV-2 related acute respiratory distress syndrome (ARDS) and to see if dornase alfa reduces the amount of bronchoalveolar lavage and blood markers of NET activity. The study will recruit patients who are on mechanical ventilation for respiratory failure related to SARS-CoV-2 positive infection and have ARDS based upon Berlin criteria. The investigators aim to recruit 10-20 patients for this study.