Combination Assessment Trial of COVID-19 Vaccines (COMBAT-COVID)
COVID 19 VaccineThis is a randomized, phase II trial which will be conducted among volunteers aged 18 years and above in Karachi, Lahore and Islamabad, Pakistan. The trial will have nine arms and is an open label study. Trained persons will administer the vaccine and draw blood under strict aseptic measures. The immune responses using pseudo neutralizing antibodies against SARS-CoV-2 in COVID-19 seronegative participants receiving heterologous and homologous COVID-19 vaccines will be assessed. Anti-spike IgG antibodies by ELISA and pseudo neutralizing antibodies against SARS-CoV-2 will also be measured. The safety and reactogenicity will also be assessed by recording serious adverse events (SAE), adverse events of special interest (AESI), solicited local and systemic reactions and medically attended adverse reactions through biochemical and hematological tests or safety measures throughout the study. In most cases the adverse events are mild and self-limiting but can require medication and/or hospitalization in rare cases. Participants suffering from any adverse event causally related to the to the trial intervention will be facilitated and the cost of treatment including laboratory investigations will be provided to them. Data confidentiality will be ensured by delinking names in forms and through password protection.
The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute...
Post-acute COVID-19 SyndromeFood supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. A well-known problem of these substances in their natural form is the low bioavailability. Micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. The clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute COVID-19. This study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long COVID.
Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
COVID-19Background: The COVID-19 pandemic has challenged the health systems worldwide. Many tools have been developed in response to the pandemic, but there is no current way to quickly screen multiple people for the disease. Research has shown that people with COVID-19 have higher levels of some proteins involved in the immune response and inflammation. These proteins can be detected in sweat using a special camera. Researchers want to see if analysis of sweat from fingerprints could be used to detect COVID-19 infection in people. Objective: To test a new technology to detect COVID-19 infection based on an analysis of sweat from fingerprints. Eligibility: Adults ages 18 and older who tested positive or negative for COVID-19 within the last 7 days. Design: Participants will visit the NIH Clinical Center for one day within 7 days from COVID-19 testing. The visit will last for 3 to 4 hours. Participants who show symptoms for COVID-19 with a positive test will give blood samples to correlate with the sweat markers. About 1/2 tablespoon of blood will be drawn. For sweat markers, 10 fingers will be imaged by a camera using a touchless system. This will be repeated 3 times. It will take about 15 minutes. Participants will use the device. They will get instructions and watch a short video on how to use the device.
A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of...
COVID-19Upper Respiratory Infection1 moreBackground: The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. Objective: To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation. Eligibility: Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing. Design: Participants will have a physical exam. Their vital signs will be taken. Participants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks: Rest for 10 minutes. They will repeat this after each task. Hold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times. Pace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times. Breathe air that has 5% of carbon dioxide for 5 minutes. During these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer. Participants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking). Participation will last for 2 to 3 hours.
Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population
Covid19Background and Objective Persistent symptoms after COVID 19 episodes (or referred to as Long COVID) can appear at a certain period and affect the quality of life of the patients, as well as introduce other comorbidities. It is important to address the associated factors of persistent symptoms after the COVID 19 episode. By identifying these factors, a screening method could be deployed to detect individuals that are prone to persistent COVID 19 symptoms. Method: This cohort study recruit COVID 19 patients at all stages in Indonesia (including people who underwent home isolation). Patient-based clinical information is collected from the patient including the demographic information, general health status, COVID 19 vaccination, and COVID 19 treatment. The outcome is the occurrence of persistent COVID 19-related symptoms after being declared as cured. A logistic regression model and Cox Regression are applied to the model to find the associated factors. Machine learning and Deep Learning model will be constructed and deployed into a web-based application for a further screening program. Hypothesis: There is an association between duration of COVID episode, repeated COVID episode, and the presence of persistent COVID 19 Symptoms Vaccinated individual who was infected with Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV2) will have less persistent COVID 19 symptoms Individuals with comorbidities are prone to persistent COVID 19 Symptoms Appropriate medications (including early administration of antiviral therapy) lead to a lower probability of persistent COVID 19 Symptoms
3D Printed Mask Adapter Designed From Facial 3D Scans for Fit Testing.
COVID-19 PandemicHealthcare workers PPE (personal protective equipment) when interacting with patients either infected or, potentially carrying SARS-CoV-2. One of the major routes of transmission is via droplet spread through oral and nasal mucosa therefore respiratory protective equipment (RPE) is an important part of PPE. There are concerns in dentistry that droplet spread can be increased during aerosol-generating procedures (AGP). This poses an increased risk to dentists and allied professionals in a clinical setting. Fit testing is needed to ensure a mask forms a facial seal around the mouth and nose. Using a respirator mask without fit testing can reduce its effectiveness from between 6-88% with an optimal facial seal being more critical than the filtering performance. Commercial respirator masks are mass-produced for ' standard' faces, and often fail to provide a good fit for users thereby compromising the intended respirator filtering capability. Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke 3D printed mask adapter used with a soft FFP3 disposable mask provides an economical solution to address the passing of fit testing. Barts Health NHS Trust staff members who have previously failed the fit test to the first line FFP3 disposable respirator will be invited to enrol in this study. Barts/QMUL scan App will be used to capture the facial scan of the subjects using a research allocated smartphone. Participants will be asked to be clean-shaven without any facial jewellery which could hinder the scan data. The App automatically generates a customized 3D print file (.stl) which will be sent for 3D printing. The mask adapter will be fitted over the first-line FFP3 respirator once it is properly worn and checked as per the procedure.
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19Vaccination1 moreBackground: Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why. Objective: To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2. Eligibility: Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection. Design: Participants will be screened with a medical history and blood and urine tests. Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health. After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH. This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines. ...
Phase 3 Booster Vaccination Against COVID-19
COVID-19Sars-CoV-2 InfectionThe inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine.
Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19
COVID-19 PneumoniaPatients with Coronavirus Disease (COVID-19) experience distressing and challenging to manage respiratory symptoms. Interventions such as Oxygen (O2) therapy, oral opiates, and traditional nebulizers like ipratropium bromide and salbutamol, are variably effective, and therapeutic responses in individual patients are difficult to predict. The purpose of this study is to investigate the efficacy of nebulized fentanyl citrate on dyspnea, cough, and throat pain in patients with COVID-19, as well as evaluate the safety with any potential adverse events. In COVID-19, about 59% of patients will exhibit cough, 35% generalized body ache and sore throat and 31% will have dyspnea. Nebulized Lidocaine, magnesium, and opioids are alternative methods for the management of respiratory symptoms in various patients. Fentanyl nebulization was found to be effective in decreasing dyspnea in chronic obstructive pulmonary disease (COPD) patients by decreasing the rate of spontaneous respiratory rate, modulating cortical activity, and diminishing the brain stem chemoreceptor response to hypoxia and hypercarbia. The investigators hypothesize that nebulized fentanyl is superior to nebulized saline in suppressing cough, respiratory drive, improving breathlessness or dyspnea with the additional advantage of throat pain relief with minimal adverse effects in patients with COVID-19.
A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients
Covid19Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited. Because almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients. Information regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents. Analysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.