|drug442||Biological Sample Collection Wiki||0.41|
|drug787||Clinical interview Wiki||0.41|
|drug471||Blood collection Wiki||0.41|
|drug2836||Remote Problem Management Plus Wiki||0.41|
|drug2419||Patient Education Wiki||0.41|
|drug2846||Respiratory Exercise Training Wiki||0.41|
|drug490||Blood samples collection Wiki||0.41|
|drug171||Aerobic Exercise Training Wiki||0.29|
|drug783||Clinical assessment Wiki||0.24|
|drug3173||Standard Medical Treatment Wiki||0.18|
|D001008||Anxiety Disorders NIH||0.06|
|D018352||Coronavirus Infections NIH||0.06|
There are 6 clinical trials
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to : 1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis; 2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital; 3. and to have a method compatible with screening extended to populations at risk.
Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution
Description: Blood sampleMeasure: Number of increased immune population Time: Month 4
Description: Blood sampleMeasure: Number of decreased immune population Time: Month 4
Description: Blood sampleMeasure: Number of statically different phenotypes compared to control patients Time: Month 4
Description: Qualitative identification of immune subpopulations showing a significant variation compared to controls and quantification of this variation (at D1 and/or D14)Measure: Gain or loss of functional phenotypic markers between D1 and D14 Time: Day 14
Description: Qualitative identification of immune subpopulations showing a significant variation between acute and mild COVID-19 and quantification of this variation (at D1 and/or D14)Measure: Gain or loss of functional phenotypic markers between between acute and mild infections Time: Day 14
Description: Qualitative identification of immune subpopulations showing a significant variation between acute stage and recovery (at 4 months) and quantification of this variationMeasure: Gain or loss of functional phenotypic markers between D1 and month 4 Time: Month 4
Description: Blood sampleMeasure: Evaluation of V, D, J gene usage alterations in the immunoglobulin and T cell receptor (TCR) repertoires during ARDS linked to COVID-19 Time: Day 14
Description: Blood sampleMeasure: Identification of the Ig classes and of V, D, J sequences of anti-CoV-2 antibodies Time: Month 4
Description: Blood sampleMeasure: Characterization of a new set of human antibodies from patients who have recovered of COVID-19 Time: Month 4
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff. A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic. Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool. Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding. The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
Description: The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.Measure: Induced SARS-CoV2 immunity Time: At day 21 (compared to enrollment [Day 0])
Description: The presence of induced immunity will be identified on serology analysis at 6 months.Measure: Long-term protection of induced SARS-CoV2 immunity at 6 months Time: 6 months following enrollment
Description: The presence of induced immunity will be identified on serology analysis at 1 year.Measure: Long-term protection of induced SARS-CoV2 immunity at 1 year Time: 1 year following enrollment
Description: Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollementMeasure: Anti-SARS-CoV2 antibodies kinetics in blood throughout the study Time: From enrollment (Day 0) to 1 year after enrollement
Description: Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollementMeasure: Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study Time: From enrollment (Day 0) to 1 year after enrollement
Description: Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.Measure: Kinetics of serum neutralization in blood throughout the study Time: From enrollment (Day 0) to 1 year after enrollement
Description: Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 0.Measure: Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0 Time: At enrollment (Day 0)
Description: Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 21.Measure: Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21 Time: At Day 21
Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables). In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR. The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.
Description: The development of this test is based on machine learning techniques, which involve "training" a mathematical model, in which the results of the mass spectrometry analysis of saliva samples and clinical data will be used to determine the information needed to distinguish a saliva sample from a SARS-CoV2-infected participant from a healthy saliva sample.Measure: Development of a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample. Time: Day 30
Description: For each saliva sample, the status ("correct" or "incorrect") of the classification of the sample ("infected" or "not infected") by the test (MALDI-TOF MS profiling) will be determined. Then the rate of correct classification will be calculated. The test will be considered efficient when it has reached a correct classification rate of more than 95%.Measure: Rate of correct classification by the test (MALDI-TOF MS profiling) from saliva sample Time: Day 30
Description: For each saliva sample, the status ("correct" or "incorrect") of the classification of the sample ("infected" or "not infected") by RT-PCR will be determined. Then the rate of correct classification by RT-PCR will be calculated.Measure: Rate of correct classification by RT-PCR from saliva sample Time: Day 30
Description: On each saliva sample, the expression of proteins will be determined using mass spectrometry. By comparison between SARS-CoV2 infected saliva samples and non-infected saliva samples, the presence of proteins that are specifically expressed in SARS-CoV2 infected saliva samples will be determined.Measure: Identification of proteins specific to the SARS-CoV2 infection Time: Day 30
Description: On each SARS-CoV2 infected saliva sample, the presence of anti-SARS-CoV2 antibodies, by RT-PCR, will be determined.Measure: Presence of a positive anti-SARS-CoV2 antibody response by RT-PCR Time: Day 30
Description: In SARS-CoV2 infected participants (Covid+ hospitalization group and Covid+ outpatient group), the presence of a correlation between the presence of proteins specific to the SARS-CoV2 infection and the clinical evolution of patients will be determined.Measure: Correlation between the identified protein markers and the clinical course of the participants. Time: Day 30
Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.). Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media. In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal. An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.
Description: Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.Measure: Qualitative result of molecular tests for the SARS-CoV-2 virus. Time: At enrollment (day 1)
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.
Description: We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.Measure: The clinical evaluation of saliva as specimen for COVID-19 molecular test Time: 1 hour
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports