View clinical trials related to Covid19.
Filter by:COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission chains and reduce community transmission. However, Black and Latino/Hispanic populations in lower status frontline essential occupations such as food preparation, retail, building maintenance, personal services, and in-home health care have serious barriers to COVID-19 testing and, therefore, insufficient testing rates. The proposed study will use the multiphase optimization strategy framework to address the problem of low COVID-19 testing rates for this population: We will test the effects of four distinct candidate intervention components and then create an efficient multicomponent made up of the most effective combination of the components that can be rapidly scaled up in community settings to boost COVID-19 testing rates.
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.
Invasive aspergillosis (IA) are difficult to diagnose in the ICU population, as the patients often do not present the conventional risks factors of immunocompromised patients (EORTC/MSG criteria). In the ICU population, patients often present other risk factors, such as cirrhosis, COPD, influenza and currently SARS-Cov2. The clinicians are thus currently missing precise criteria to distinguish colonization from IA in these patients, while they need to decide if an antifungal treatment is necessary or not. A new algorithm, entitled BM ASP ICU, based on investigators field experience and the scientific literature, which takes into account both EORTC/MSG criteria and a combination of fungal biomarkers, was proposed recently by Haman et al, Annals Intensive Care, 2021. Additional serological assays (immunoprecipitation and ELISA) showed since their interest, especially concerning SARS-Cov2 patients, a new population at risk of IA in the ICU, which emerged in the past months. The present study aims at prospectively implementing the BM ASP ICU algorithm during two years in the routine practice of six ICU units distributed in general and teaching hospitals situated northeast of France. The BM ASP ICU algorithm would be completed by serological assays aiming at assessing a sensitization towards Aspergillus fumigatus. The investigators plan to include 400 ICU patients at risk of IA; SARS-Cov2 patients will be part of the cohort. A weekly screening including culture of respiratory samples, galactomannan antigen, fungal qPCRS (targeting A. fumigatus), and A. fumigatus serology will be applied for all included patients. The performance (sensitivity and specificity, likelihood ratios) of each fungal biomarkers, alone and in combination with others, will be assessed, for all patients, and also within subgroups of patients with specific risk factors (such as SARS-Cov2 for example). These results should lead to solid understanding of which combination of tests is optimal to diagnose IA and thus to initiate appropriate antifungal treatment. the investigators hope that this study will result in improved survival rate of ICU patients with IA.
Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.
Covid-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.
The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure. Biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. Preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin). The severity of Vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as D-dimer or prothrombin time/activated partial thromboplastin time. The severity of the disease is mainly driven by diffuse interstitial lung diseases. YKL-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. In ILD, YKL-40 has been described to be associated with the severity of lung diseases and with the risk of death. YKL-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage. .
The phase Ⅱ trial adopts a randomized, double-blind, placebo-controlled design to evaluate the immunogenicity and safety profile of LYB001 in healthy adults aged 18 years and older. This Phase III study adopts a single-arm, open-label design to evaluate the expanded safety of LYB001 in healthy subjects 18 years of age and older. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56. The phase Ⅱ trial will be carried out in an age-sequential enrolment manner: 1. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged 18-59 years in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of younger adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1. 2. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged ≥60 year in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of older adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1. 3. The phase Ⅱ trial will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination. Phase III trial (the expanded safety study): 1. After completion of the 7-day safety observation following the first immunization of all cohorts in the Phase II trial, a DSMB meeting will be held to recommend whether to initiate enrollment of participants in the Phase III trial. A total of 1200 subjects will be enrolled in younger adult and older adults, with older adults accounting for ≥20% of the population, and appropriate doses will be determined based on the results of early clinical trials. 2. The phase III trial will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.
This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research & Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.