PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19
COVID-19COVID-19 Pandemic3 moreA galectin antagonist prevents viral entry of Sars-CoV-2 virus by blocking the specific terminal on the surface receptors that enables the virus to enter human cells. This inhibitor - ProLectin M is a novel substance that is given orally to individuals who have an infection with Sars-CoV-2 or its subsequent mutations causing COVID19 disease. The oral tablet is chewed every hour, for 8 hours daily, for 7 days. We hypothesize that patients receiving the active investigational product (ProLectin M), irrespective of their vaccination status, or underlying medical conditions, will have a faster recovery from COVID19 compared to those receiving its matching placebo. The trial is approved by an Institutional Review Board for safety and all participants will need to provide written informed consent to participate in this trial. The safety of ProLectin M is established as the drug substance is recognised as a safe substance. However, its benefits in relieving patients from the COVID19 infection and providing the patients faster recovery from its clinical symptoms and prevention of delayed sequelae of the infection has not been proven yet.
Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary...
COVID-19 Respiratory InfectionPulmonary TuberculosesSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the Coronavirus disease (COVID-19). Tuberculosis (TB) is the foremost cause of infectious deaths globally. In 2025, an additional 1.4 million TB deaths could occur as direct consequence of the COVID-19 pandemic. It is postulated that individuals with latent or active TB are more susceptible to SARS-CoV-2 disease and that COVID-19 disease rate is high in patients with active TB, although the evidence is still scarce. TB and SARS-CoV-2 are both infectious diseases which primarily attack the alveolar region of the lungs and share common symptoms. SARS-CoV-2 disease can induce innate and adaptive immunity, but uncontrolled inflammatory innate immunity and impaired adaptive immune responses may be associated with severe tissue damage, both locally and systemically. People with coinfection (COVID-19 and TB disease) might potentially have impaired protective immune responses and treatment outcomes, specifically as far as anti-tuberculosis treatment is concerned. However, very little is known about the immunological underpinnings in this interface between TB and COVID-19 on the effect of SARS-CoV-2 disease on disease severity, response to treatment and treatment outcomes in pulmonary tuberculosis. Investigators hypothesize that altered immunity due to prior or present asymptomatic disease with SARS-CoV-2 virus can lead to altered immune responses and systems biology, increased severity and altered treatment outcomes in TB disease. The main objective of the study would be to evaluate the baseline differences in immune cells populations immune cell responses at baseline and at the time of treatment (2nd month) and end of treatment. Further, Investigators would be evaluating the changes in proteomic profiles in a subset of these individuals. In addition, immunological assays examining differences in T cell populations, measuring levels of various cytokines and by immunophenotyping as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross-talk between active TB patients with or without SARS-CoV-2. The secondary objective would be to study the clinical features, disease severity, mycobacterial burden and treatment outcomes in a cohort of SARS-CoV-2 infected (asymptomatic PCR or Antibody+) and non-infected patients with active pulmonary TB.
Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal...
Respiratory Tract; InfectionUpper (Acute)2 moreRationale: Respiratory tract infections (RTI) are a major cause of morbidity in young children in high- income countries and the major cause of mortality in developing countries. Causative bacteria and viruses are regular residents of the nasopharynx of asymptomatic individuals (colonization) and live there together with other presumed harmless commensals, without causing disease. These non-pathological infections/colonization episodes are important for transmission, intermediate step to disease and boost immune responses. The investigators recently validated the use of minimally-invasive nasal sampling methods that can be done at home for the study of host and microbial parameters in adults and children. In this study the investigators will focus on the daily microbial and immunological composition of the nasopharynx during health in relation to symptoms. Primary objective: Associate acquisition of pneumococcal colonisation with levels of pre-existing polysaccharide specific memory B cells. Secondary objectives include: Validate the use of synthetic absorptive matrices (SAM) for detection of respiratory pathogens versus nasopharyngeal swabs (NPS) and saliva; Assess dynamics of URT infection/colonisation and examine its relationship with symptoms, host responses and microbiota; Measure transmission between children and parents and immune responses in parents. Study design: Prospective community-based cohort study.total of 45 children, aged 1-5 years old attending daycare or (pre-)school, will be included, including a pilot of 10 children to assess tolerability. If there are insufficient pneumococcal acquisitions in the study to assess the primary outcome, additional children can be recruited in groups of 3 or 4 children (up to 10). For a subset of participating children, both parents will be asked to self-collect daily saliva during the study. Primary study parameters: Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised Secondary study parameters: Dynamics of respiratory bacteria and viruses during URT infection/colonisation. Presence and load for bacteria and viruses in children in SAM versus saliva and NPS. Local microbiota and immune profiles and association with infection/colonisation and symptomology. For a subset of parents, daily presence and load of bacteria and viruses as well as host immune factors measured in saliva.
Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma...
Human Papilloma VirusRecurrent Respiratory PapillomatosisThis research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP). The names of the study drugs involved in this study are: Pembrolizumab Lenvatinib
University Hospital of Ioannina COVID-19 (Coronavirus Disease 2019) Registry
COVID-19 (Coronavirus Disease 2019)COVID-19 Pandemic6 moreCOVID-19 (Coronavirus Disease 2019) Registry of University Hospital of Ioannina. Retrospective datasource registry with quantitative and qualitative patient data from the hospital medical records. Epidemiological, clinical and laboratory parameters are recorded on 7 different time points (day: 1, 3, 5, 7, 9, 11, 15) concerning 793 variables of interest in an electronic (computerised) database. Patients are also followed-up after 90 days from hospital discharge (number of visits of follow-up depends on patient's health status) at the Post-COVID and Long-term effects of coronavirus (long COVID) outpatient clinic of University Hospital of Ioannina. Data from this outpatient clinic are also recorded in an electronic database (189 variables of concern for each patient)
Respiratory Muscles Electromyography in Patients With Covid-19
COVID-19 Respiratory InfectionThis research is characterized as a cross-sectional observational study, which follows the recommendations of the STROBE instrument. Therefore, it is being performed at the Intensive Care Unit of Hospital Otávio de Freitas (HOF) in Recife/PE, with patients over 18 years of age who have a clinical diagnosis of COVID-19, using two methods of oxygen therapy (Nasal Oxygen Catheter and mask without rebreathing). That through clinical assessments of the disease, degree of severity of COVID-19, perception of respiratory effort and electromyography of respiratory muscles. The hypothesis of this study is that the higher the level of muscle activation and fatigue, the greater the risk of intubation and length of stay in the ICU. The rationale for the study is that Surface Electromyography is a widely used resource to analyze and compare respiratory muscle responses and thus provide prior treatment. Identifying which muscles undergo changes in patients with COVID-19 is essential to analyze and understand the likely functional changes of the respiratory system in COVID-19 and how they reflect according to their level of respiratory support and disease severity.
Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )
COVID-19 Respiratory InfectionSotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. As the clinical trial results are too preliminary for the drug to enter routine use in UAE the drug approved only for emergency use, until further evidence shows Sotrovimab is effective, so we thought about this study as a tool to assess the success of Emirats Health service (EHS) strategy for fighting against COVID-19 outside the hospital setting.
Follow-up of Covid-19 Long Term Sequelae
COVID-19 PneumoniaCOVID-19 Respiratory Infection16 moreThe protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae. The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.
SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
COVID-19SARS-CoV-2 Virus4 moreThe goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ for the detection of COVID-19 in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19 screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19. The hypotheses are: (H1) The imPulse™ Una e-stethoscope has 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. Based on these promising studies, we will operationalize and deploy the imPulseTM Una e-stethoscope and other associated technology form factors into DoD use-cases. (H2) 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 symptoms according to BAMC's current screening procedures; Have study data collected; Complete a COVID-19 symptoms questionnaire; imPulseTM Una e-stethoscope 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.)
Daily Vitamin D for Sickle-cell Respiratory Complications
Sickle Cell DiseaseAnemia13 moreThis study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease. This study is funded by the FDA Office of Orphan Products Development (OOPD).