View clinical trials related to Covid19.
Filter by:The coronavirus disease 2019 (COVID-19) outbreak, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread globally, representing a serious threat to public health. While waiting for highly effective treatments or the development of an effective vaccine, it is necessary to reactivate key economic activities that are related to leisure and culture in an environment that is safest for the participants. The use of a rapid screening test for SARS-CoV-2 viral antigens with high sensitivity could be a useful tool to detect asymptomatic SARS-CoV-2 infected people, and thus be able to carry out events related to leisure in a safe environment. The aim of this study is to make a mass screening of asymptomatic infection of an (i) experimental group (public attending a massive mass musical show) and (ii) a control group (they will not enter the event) prior to entering to the event. Randomization 1: 1 by random blocks of the participants with a negative antigen test in the experimental group (attending the event) and the control group (they will not enter the event). Control with a new Polymerase Chain Reaction (PCR) test 8 days after the event (D8) in the participants of both randomized groups Control of the appearance of symptoms through a questionnaire 10 days after the event (D10), in the participants of both groups with a negative result on day 8. Validation of a rapid antigen detection test by comparison with the PCR technique. The indoor activity will include an array of measures designed to reducing the contagion risk, including: mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking, enhanced ventilation of the whole indoor area, and avoiding queues. All subjects will have downloaded an app in their smart phones to help contact and place tracing during the event, to trace potential transmissions. This app will remain active for 8 days, until the last virologic control. The inclusion criteria will allow only subjects with an age <60 years, without comorbidities, and who do not live with old adults in their homes, to further reduce the risk of potential complications and transmission to at risk individuals.
Background: Up-to-date, there is no recognized effective treatment or vaccine for the treatment of coronavirus disease (COVID-19) that emphasize urgency around distinctive effective therapies. This study aims to evaluate the anti-parasitic medication efficacy "Ivermectin" plus standard care (Azithromycin, Paracetamol, vitamin C, Zinc, Lactoferrin, Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer > 1000 and/or steroids) in the treatment of mild/moderate and severely ill cases with COVID 19 infection versus Hydroxychloroquine plus standard care, as well as Ivermectin prophylaxis of health care and/ or household contacts. Subject and methods: 600 subjects; 400 symptomatic confirmed COVID-19 patients and 200 health care and household contacts distributed over 6 groups; Group I: 100 patients with Mild/Moderate COVID-19 infection received a 4-days course of Ivermectin plus standard care; Group II: 100 patients with mild/moderate COVID-19 infection received hydroxychlorquine plus standard care; Group III: 100 patients with severe COVID-19 infection received Ivermectin plus standard of care; Group IV: 100 patients with Severe COVID-19 infection received hydroxychlorquine plus standard care. Routine laboratory investigations and real time- polymerase chain reaction (rt-PCR) were reported before and after initiation of treatment. Group V stick to personal protective equipment (PPE) plus Ivermectin, and Group VI stick to PPE only and both groups were followed for two weeks.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection is a pandemic, which has affected approximately 4 lakhs individuals and claimed 16,362 deaths till now. SARS-CoV-2 has been associated with myocarditis and renal dysfunction. Patients hospitalized for Covid-19 severe infection are more prone to excessive coagulation activation leading to thrombotic events both in the venous and arterial circulations, due to excessive inflammation, platelet activation, endothelial dysfunction, and stasis. Nearly 20% of COVID-19 patients present severe coagulation abnormalities, which may occur in almost all of the severe and critical ill COVID-19 cases. Concomitant venous thromboembolism (VTE), a potential cause of unexplained deaths, has been frequently reported in COVID-19 cases, but its management is still challenging due to the complexity between antithrombotic therapy and coagulation disorders. The importance of high D-dimer and Fibrin degradation product level to determine the patient prognostic and the risk of thrombosis is known. In a French study, it was found that a high rate of thromboembolic events in COVID-19 patients treated with therapeutic anticoagulation, with 56% of VTE and 6 pulmonary embolisms. Preliminary reports on COVID-19 patients' clinical and laboratory findings include thrombocytopenia, elevated D-dimer, prolonged prothrombin time, and disseminated intravascular coagulation. COVID-19 patients with acute respiratory failure present a severe hypercoagulability rather than consumptive coagulopathy. Another study highlights this common finding in most COVID-19 patients with high D-dimer levels which are associated with a worse prognosis. Cases showed significantly higher fibrinogen and D-dimer plasma levels versus healthy controls (p < 0.0001). Markedly hypercoagulable thromboelastometry profiles were observed in COVID-19 patients, as reflected by shorter Clot Formation Time (CFT) in INTEM (p = 0.0002) and EXTEM (p = 0.01) and higher Maximum Clot Firmness (MCF). Fibrin formation and polymerization may predispose to thrombosis and correlate with a worse outcome. Global VE tests provide a more physiologic assessment of coagulation and should be considered to guide blood transfusion requirements in liver transplantation and other major surgery. Its application in patients with Covid19 or in a critical care setting requires more data. Viscoelastic tests, which include TEG, ROTEM, and Sonoclot, offer a means of assessing the activity of pro-and anticoagulant pathways, hyperfibrinolysis, and excessive clot lysis. Assessment of clot formation can be performed in 10 to 20 minutes as a point of care (POC) test; however, assessment of clot lysis takes 30 to 60 minutes. SIRS and sepsis trigger the release of endogenous heparinoids, or a heparin-like effect (HLE), due to small endothelium/mast cell-derived glycosaminoglycan's, which can be detected on heparinase-treated viscoelastic assays. Viscoelastic testing of global coagulation such as thromboelastometry and Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products and anticoagulation. it is deemed necessary to determine the influence of Covid 19 on coagulation parameters using point of care coagulation using sonoclot and conventional coagulation tests. In this prospective trial, the investigators aim to evaluate coagulation abnormalities via traditional tests and whole blood Sonclot profiles in a group of 50 consecutive patients with critically ill COVID-19 patients admitted to the Covid ICU OF Nehru Hospital extension, Postgraduate Institute of Medical Education and Research, Chandigarh.
This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older
The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements. Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.
Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study. In December 2021, there was a drop in the number of hospitalizations and the cases of COPD, tuberculosis and HIV associated with COVID-19, which are outside the inclusion criteria of this study. After the initial data of the study, there was a discussion with Anvisa and the size of the sample calculation was revised by amendment 4 (180 participants), and the methodology of statistical analysis for a new sample calculation was "a formula for sample calculation for superiority studies using proportions, according to the book do Chow et al (Chow, S.-C., Shao, J., Wang, H., &Lokhnygina, Y. Eds. 2017. Sample Size Calculations in Clinical Research: Third Edition, Chapman and Hall/CRC). Thus, Anvisa concluded that the adjustments are in accordance with the agency's guidelines, approving E4, which was later also approved by the Ethics Committee.
Chinese medicine has been used for thousands of years in the treatment of epidemic diseases. Through the long-term struggle with the epidemic, Investigators have accumulated and explored a lot of prevention and control experience. According to recent reports, Chinese medicine plays an important role in the treatment of COVID-19. For example. Therefore, it is of great clinical significance to further develop the prevention of COVID-19 by Chinese medicine. According to the 《Diagnosis and treatment of COVID-19》published by National Health Committee and the experience of professional TCM physician, although the disease is generally susceptible, individuals with the body constitution of "deficiency of Qi and Yang" and "deficiency of Qi and Yin" are more prefer to suffer from COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19 in Chinese medicine. After a series of questionnaire surveys and blood sample collection, investigators can estimate subjects with body constitution is more likely to infect COVID-19.
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).
COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation. Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions. On these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.