View clinical trials related to SARS-CoV-2.
Filter by:The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.
The rapid spread of SARS-CoV-2 (also known as 2019-nCoV and HCoV-19 1), a novel beta coronavirus B lineage (βCoV), has sparked a global coronavirus disease (COVID-19) pandemic. It has been suggested that RRAR, a unique furin-like cleavage site (FCS) in the spike protein (S) that is absent in other B βCoV lines such as SARS-CoV, is responsible for its high infectivity and transmissibility. Furin is a protein with a special function of a fermentative biocatalyst: which recognizes the degree of maturity of a group of amino acids Functionally, Furin works to renew the body, but it is also a path to the introduction of the SARS-CoV virus into a living human cell, HIV virus, Ebola virus, and others that penetrate a human cell using the Furin protein, sending a conditioned signal from the extracellular matrix, and gives the virus the opportunity to merge the protein of the coronavirus spike and the protein content of the cut cell, which activates the phase of virus replication in the body. We hypothesize that measuring the quantitative indicators of Furin protein expression in patients (at the onset of the disease) who have recovered from SARS-CoV-2 and vaccinated (with all types of vaccines) against coronavirus can provide an understanding of the molecular-cellular mechanisms of the virus's cellular invasion. This means that it will be possible to find new ways to prevent the fusion of the membranes of infected cells with normal ones (this mechanism allows the virus to spread throughout the body without leaving the affected cells). Protein identification will be carried out by Enhanced Chemiluminescence (ECL) (the method of enhanced chemiluminescence differs from the method of immunochemical staining using chromogenic substrates by a much greater sensitivity)
Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.
Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) - Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy - Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy - Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy
Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.
SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.
The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab. Secondary objectives - To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay. - Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms. - Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test. - The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.
This study is clinical trial (intervention study with external comparison group) to test vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years from Viana city - Espírito Santo (ES)/Brazil, on the incidence of new cases over 12 months following treatment, compared to an external group from same state and adjusted for socio-demographic and epidemiological variables.
Our current focus is to reduce the spread of COVID through distribution of Rapid Antigen Test Kits (ATKs) to low-income, high-risk communities across Bangkok. Hospitals across Thailand have been operating over capacity for many months, both in receiving the high number of cases as well as in testing for COVID. RT PCR, although highly sensitive, requires potentially infectious people to travel to testing sites, wait in line, and takes 1-2 days to return results, leading to further spread of COVID through increased contact with other high-risk individuals. On the contrary, testing via an Antigen Test Kit (ATK) can be done by everyone at home with the potential to test more frequently than the PCR test due to much cheaper cost. This means that ATK testing can be mixed into people's daily lifestyle, but another underlying reason is that ATKs only show test results as positive only when an infected person is contagious. Another key advantage is the rapid results, which helps people identify risks quickly, limiting spread even faster. Our trial therefore aims to achieve the following primary objective: To monitor the results of freely distribute ATKs in real environments to measure its effectiveness in reducing COVID spread in communities by comparing the incidence of COVID-19 between communities with rapid antigen tests and without rapid antigen tests. Secondary objectives are: 1. To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests. 2. To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests. 3. To study factors affecting community-acquired COVID-19 in these communities. 4. To campaign for the government to recognize the importance and effectiveness of weekly testing, and propose suitable strategies to fight COVID.
This study will collect information on the safety of BNT162b2 products for at least 15,000 subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).