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The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.
A research team member will brush the inferior surface of the subjects' middle turbinate (nasal cavity) using a cytology brush to obtain the cells needed to perform our functional respiratory assays. An individual trained in phlebotomy will draw one 3 ml lavender top tube of blood to test c-reactive protein, calprotectin, and lactoferrin. They will also draw a 5 ml gold top serum separator tube of blood to test fibroblast growth factor-19. The participant will answer questions from the baseline survey and report their current medications interview-style with the research team member.
Coronaviruses (CoVs) have caused the severe acute respiratory syndrome (SARS) outbreak, the Middle East Respiratory Syndrome (MERS) outbreak, and now the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Although there are several approved or authorized vaccines for SARS-CoV-2, there are currently no vaccines approved to prevent diseases caused by multiple different coronaviruses. Two countermeasures with promise for controlling coronavirus outbreaks are recombinant neutralizing antibodies and vaccines directed against the virus. Between these two countermeasures, the ultimate solution to control the current COVID-19 pandemic and future CoV outbreaks is a pancoronavirus vaccine. In particular, a vaccine that can induce broader protection and can prevent severe disease caused by current SARS-CoV-2 variants of concern would help mitigate significant morbidity and mortality following SARS-CoV-2 infection. Additionally, an optimal pancoronavirus vaccine would prevent severe disease from other SARS-related viruses in the genus of coronaviruses-betacoronavirus-that are responsible for past outbreaks or could cause the next major outbreak in humans. Such a broadly active coronavirus vaccine would be an impactful first step towards preventing all life-threatening coronavirus human disease. The proposed vaccine immunogen (Cov-RBD-scNP-001) is composed of an engineered receptor binding domain (RBD) of SARS-CoV-2 WA-1 covalently linked in vitro to the surface of a Helicobacter pylori ferritin protein nanoparticle (RBD-scNP). The RBD has been engineered at two sites to improve its expression. The protein nanoparticle is composed of 24 individual ferritin subunits each of which can have a SARS-CoV-2 WA-1 RBD attached to it via a nine amino acid linker. The protein nanoparticle will be delivered with 3M-052-AF adjuvant - a TLR 7/8 agonist.
The current standard of care for diagnostic of SARS-CoV-2 infection involves sample collection which is then prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is time consuming and dependent on expensive instrumentation and trained technicians to perform both the sample preparation and assay. In many cases, sample turn-around times can take hours to several days. There are no established monitoring nationwide protocols for COVID-19 prevention of infection. Due to the lack of such protocols, this study will provide the proper experience to design a safe monitoring schema of asymptomatic cases of COVID-19. Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness. Therefore, we intend to use these RDT (Rapid diagnostic tests) for other use. There are several studies that point to the importance of the use of RDTs to monitor COVID-19 (3). The recent metadata indicate that the performance of the antigen test is crucial for obtaining good results to detect positive cases. We have already validated in the laboratory and using relevant clinical samples several different labels of antigen tests and we have compared them with already approved USA FDA antigen tests to confirm their performance prior to using them in this study. This project aims to monitor once a week the presence of SARS CoV-2 antigens using anterior nares (AN) swab self-process, executing the test and recording of the result, immediately after. The lack of affordable diagnostic tests which can detect the presence of SARS-CoV-2 in the general population which can give near real-time results is one critical missing control intervention in USA for the control of the pandemic and the spread of this disease. As public health restrictions begin to ease and people return to normal activities, while the COVID-19 pandemic is still a threat, a rapid diagnostic assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to screen asymptomatic individuals. The routine use of such rapid tests is a key element to show efficacy of protocol. We adjusted to once a week testing based on the medium to low risk of the elderly population of this study. The list of rapid nucleoprotein tests utilized in the current study are: NETO Corona test, Novir INSTA-TM COVID-19 Rapid Antigen test, COVICHEK COVID-19 Ag Test, SpectraBiotech COVID-19 track antigen test, Blandford Biotech AS-15™ Rapid Antigen Detection Kit SARS-CoV-2 Test (Colloidal Gold Method), Abbott BinaxNow tests. BACKGROUND The SARS-CoV-2 Direct Antigen Rapid Test ("Lateral flow") is an immunoassay developed for the qualitative detection of SARS-CoV-2 viral particles/secreted protein in anterior nasal swabs and/or saliva samples from both asymptomatic and suspected participants with COVID-19 infection. Lateral flow strips are printed with a monoclonal antibody that binds the signature SARS-CoV-2 viral particles/protein (Test line) and a control antibody (Control line) for quality control. A second monoclonal antibody is attached to gold nanoparticles (conjugate) and quencher buffer, and mixed with the nasal sample. The SARS-CoV-2 nucleocapsid protein attach to both antibodies resulting in a visual line on the test strip within 15 minutes. Prior experience in the detection of virus and viral proteins via antibody binding using lateral flow have been done through IDx20, Inc. The Housing Authority and the Public Health Department of the City of Chelsea will be overseeing this study.
The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization. To meet the objective and execute the deliverables for this program of effort, the A\&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings. Goals: 1. Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A\&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19, Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19, Flu, and/or RSV. The hypotheses are: (H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their usability between the devices. (H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic Respiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those not infected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR and molecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their captured traces in the early identification of disease/illness analyzed by the devices built in algorithms. (H3) In the mid to long-term, this approach will also be explored as a diagnostic system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments. Participants will: * Be consented; * Be screened for COVID-19, Flu, and/or RSV symptoms according to BAMC's current screening procedures; * Have study data collected; * Complete a symptoms questionnaire; * imPulseTM Una and TOR e-stethoscopes examination will be conducted; * Participants will be compensated for completing all study requirements. (Active-Duty personnel must complete the study procedures while off-duty in order to receive compensation.)
OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.
The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be important in the understanding cardiac function and prediction of cardiopulmonary symptoms, physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research will allow us to identify the causes of lasting cardiopulmonary symptoms and begin developing cardiac and lung directed therapies accordingly.
A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).