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NCT ID: NCT04490772 Not yet recruiting - Infectious Clinical Trials

Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

Start date: July 2020
Phase:
Study type: Observational

Patients confirmed COVID-19 with gastrointestinal manifestations will be included. Characteristics and outcomes will be described for them.

NCT ID: NCT04483232 Not yet recruiting - Epidemiology Clinical Trials

Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

AERIO
Start date: August 2020
Phase:
Study type: Observational

Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.

NCT ID: NCT04453540 Not yet recruiting - Covid-19 Clinical Trials

FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context

FAP-REA
Start date: July 1, 2020
Phase:
Study type: Observational

The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease. During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods. In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.

NCT ID: NCT04453488 Not yet recruiting - Covid-19 Clinical Trials

Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

Start date: July 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.

NCT ID: NCT04415918 Not yet recruiting - Clinical trials for Clostridium Difficile Infection Recurrence

Bezlotoxumab Efficacy and Tolerability in Cancer Patient

Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Investigation of efficacy and tolerability of bezlotoxumab in patients with cancer diagnosis in terms of preventing CDI recurrence.

NCT ID: NCT04413838 Not yet recruiting - Clinical trials for Obesity, COVID-19 Infection

Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection

NIVISCO
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT ID: NCT04400019 Not yet recruiting - Clinical trials for Coronavirus Infection

Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)

PREVICHARM
Start date: September 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

NCT ID: NCT04391400 Not yet recruiting - SARS-CoV-2 Clinical Trials

The Use of Peripheral Blood Specimens From Patients Suspected of Having SARS-CoV-2 Infections in Research Studies Intended to Support the Development of COVID-19 Detection Methods, Treatments, and/or Vaccines

Start date: June 1, 2020
Phase:
Study type: Observational

Invivoscribe, Inc. and its wholly owned subsidiary LabPMM, LLC are collecting peripheral blood specimens from patients with suspected SARS-CoV-2 viral infections. These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC. Specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel SARS-CoV-2 detection methods and COVID- 19 treatments and/or prevention methods (e.g. drug or vaccine development).

NCT ID: NCT04390607 Not yet recruiting - Clinical trials for Prosthetic Joint Infection

Leukocyte Esterase Sensor Test

Start date: November 1, 2020
Phase:
Study type: Observational

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

NCT ID: NCT04389801 Not yet recruiting - Covid 19 Clinical Trials

Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection

Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images