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Corona Virus Infection clinical trials

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NCT ID: NCT04910971 Recruiting - Inflammation Clinical Trials

Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year

Start date: January 31, 2021
Phase:
Study type: Observational

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity. SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates. In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpotā„¢ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLDā„¢ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination.

NCT ID: NCT04797091 Recruiting - Clinical trials for Corona Virus Infection

Kidney in Coronavirus Disease 2019 Registry

KidneyCOVID19
Start date: April 20, 2020
Phase:
Study type: Observational

The SARS-CoV-2 virus is a virus newly identified in January 2020. The WHO defined COVID-19 as a health emergency of international importance. The clinical manifestation of the COVID-19 disease cannot be fully described in the short time. First insights in patients suffering from acute kidney injury (AKI) during COVID-19 indicate severe course with high mortality. The locally varying spread of SARS CoV-2 infection requires a better understanding of clinical course of COVID-19 in order to be able to establish future treatment approaches. The examination of attributable mortality and costs of COVID-19 will need to be studied on a multinational basis and therefore Kidney in COVID-19 Registry will particularly use a matched case control design.

NCT ID: NCT04707833 Recruiting - Clinical trials for Corona Virus Infection

Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

SeroCOV
Start date: November 26, 2020
Phase: N/A
Study type: Interventional

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months. In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.

NCT ID: NCT04707820 Recruiting - Clinical trials for Corona Virus Infection

Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

ImmuCoV
Start date: April 16, 2020
Phase: N/A
Study type: Interventional

The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France. Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it. To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary. In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.

NCT ID: NCT04705766 Recruiting - Covid19 Clinical Trials

KIDney Injury in Times of COVID-19 (KIDCOV)

KIDCOV
Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

NCT ID: NCT04636021 Recruiting - Clinical trials for Corona Virus Infection

Restoring Non-Emergent Cardiovascular Care in the Peri- COVID-19 Era

RECIPE
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures

NCT ID: NCT04627623 Recruiting - Covid19 Clinical Trials

Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration

EpiSARS2
Start date: June 22, 2020
Phase:
Study type: Observational

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

NCT ID: NCT04609865 Recruiting - COVID-19 Clinical Trials

Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia

LidoCovid
Start date: November 4, 2020
Phase: Phase 3
Study type: Interventional

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia. Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.

NCT ID: NCT04583566 Recruiting - Clinical trials for Corona Virus Infection

Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients

Start date: October 4, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.

NCT ID: NCT04579588 Recruiting - Clinical trials for Corona Virus Infection

Understanding Immunity to the Flu Vaccine in COVID-19 Patients

Start date: October 29, 2020
Phase:
Study type: Observational

The purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.