Covid 19 Research using Clinical Trials (Home Page)
Blood sampleWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1092 | Stool collection or fecal swab Wiki | 0.58 |
| drug1046 | Sputum sample Wiki | 0.58 |
| drug405 | End tidal breath sample Wiki | 0.58 |
| drug177 | Blood sample for whole genome sequencing Wiki | 0.58 |
| drug1371 | phone call Wiki | 0.58 |
| drug656 | Low or upper respiratory tract sample Wiki | 0.58 |
| drug1142 | Tests Wiki | 0.58 |
| drug1209 | Urine sample Wiki | 0.58 |
| drug741 | Nasopharyngeal swab Wiki | 0.41 |
| drug347 | Data collection Wiki | 0.33 |
| drug506 | Hydroxychloroquine (HCQ) Wiki | 0.33 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000856 | Anorexia Nervosa NIH | 0.58 |
| D000855 | Anorexia NIH | 0.58 |
| D012120 | Respiration Disorders NIH | 0.22 |
| D012140 | Respiratory Tract Diseases NIH | 0.18 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D007239 | Infection NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.03 |
There are 3 clinical trials
Clinical Trials
1 Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly
The aim of this study is to generate epidemiological data to further explore determinants of Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral pathogens to Acute Exacerbation of COPD (AECOPD) episodes.
NCT01360398 Respiratory Disorders Procedure: Blood sample Procedure: Sputum sample Procedure: Nasopharyngeal swab Procedure: Urine sample Procedure: End tidal breath sample Other: Data collection Other: Tests MeSH:Respiration Disorders Respiratory Tract Diseases
Primary Outcomes
Description: An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.
Measure: Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) Time: During year 1Description: Bacterial pathogens assessed were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Steptococcus pneumoniae (Sp), Staphylococcus Aureus (Sta), Pseudomonas aeruginosa (Psa), any or other. For each bacteria, the means and CIs were estimated from Negative Binomial model taking into account the follow up time.Estimated exacerbations were presented as mean number of exacerbations/ subject/ year.
Measure: Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens Time: During Year 1Description: Bacterial pathogens assessed, by culture, were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Streptococcus pneumoniae (Sp), Staphylococcus aureus (Sta), Pseudomonas aeruginosa (Psa), any bacteria or other bacteria. Overall exacerbation rate is the average number of exacerbations for each subject during their time in the study.
Measure: Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum Time: During Year 1Secondary Outcomes
Description: Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for any bacteria and Hi.
Measure: Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi Time: During Year 1Description: Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Mcat and Sp.
Measure: Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp Time: During Year 1Description: Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Sta, Psa and other bacteria.
Measure: Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria Time: During Year 1Description: The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date.
Measure: Mean Number of Days Between 2 Consecutive AECOPDs Time: During Year 1Description: The exacerbations of chronic pulmonary disease tool version 1.0 (EXACT) is a validated self-administered instrument that evaluates the effects of pharmacologic treatment on acute exacerbations of COPD. Analyses of exacerbations in relation to morning or evening EXACT-PRO e-diaries were presented as follows: descriptive statistics on the EXACT daily scores tabulated at enrolment, at any stable and at any, mild, moderate or severe exacerbation visit. EXACT-PRO contains 14 questions with scores ranging from 0 to 4, where 0= best outcome while 4= worse outcome.
Measure: Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit Time: During Year 1Description: The COPD assessment test (CAT) is a validated self-administered instrument designed to provide a simple and reliable measure of health status in COPD patients. Its properties have been shown to be similar to the St George's respiratory questionnaire (SGRQ). The CAT comprises 8 items and has a scoring range of 0-40, 0= most positive answer and 40= most negative answer. In this study, the subjects were to complete the CAT questionnaire every 3 months.
Measure: Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit Time: During Year 1Description: The NEADL assessed (quarterly in the present study) the ease or difficulty in performing extended activities of daily living. The NEADL scale contains 22 items, each measured on a 4-point Likert scale. There are four dimensions: mobility (6 items); kitchen (5 items); domestic (5 items); leisure (6 items). These are summed producing a total score reflecting general functioning. Each of the 22 individual items had 2 possible scores (0 or 1). Therefore, the range of the NEADL score was 0 to 22. Lower scores indicate greater levels of disability while higher scores indicate greater independence.
Measure: Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit Time: During Year 1Description: The EQ-5D is an established measure of generic health outcome that provides a simple descriptive profile and a single index value that can be used in clinical and economic evaluation of healthcare and in population surveys. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 100 (best health state). The negative numbers presented represent a decrease from baseline values and a worsening of health.
Measure: Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit Time: During Year 1Description: AECOPD health care type included: general practitioners (other than the study doctor), pneumologists, other specialists, hospital emergency department, home care nurses, pulmonary rehabilitation programs and/or nutrition advices.
Measure: Number of Subjects Receiving Various Health Care Types During AECOPD Time: During Year 1Description: Serious adverse events (SAEs) include medical occur-rences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disabil-ity/incapacity.
Measure: Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal Time: During Year 1Description: Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria.
Measure: AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay Time: During Year 1Description: Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus.
Measure: AECOPD Rate With Overall and Specific Viral Pathogens in Sputum Time: During Year 1Description: Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Mild exacerbations were defined as worsening symptoms of COPD that were self-managed by the patient.
Measure: Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum Time: During Year 1Description: Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Moderate exacerbations were defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics.
Measure: Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum Time: During Year 1Description: Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Severe exacerbations were defined as worsening symptoms of COPD that required treatment with in-patient hospitalisation or home care intervention.
Measure: Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum Time: During Year 1Description: An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD. AECOPD severity was assessed as: any, mild, moderate and severe. Any = any COPD symptom regardless of severity. Mild = Worsening symptoms of COPD that are self-managed by the patient. Moderate = Worsening symptoms of COPD that require treatment with oral corticosteroids and/or antibiotics. Severe = Worsening symptoms of COPD that require treatment with in-patient hospitalisation or home care intervention.
Measure: AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity Time: During Year 12 Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients. The objectives of this study are : - To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients. - To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support. - To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.
NCT04354766 COVID Other: Blood sample
Primary Outcomes
Description: Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
Measure: Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2. Time: 3 weeks3 Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
NCT04376476 Infection, Coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 Biological: Blood sample Biological: Low or upper respiratory tract sample Biological: Stool collection or fecal swab Genetic: Blood sample for whole genome sequencing Other: phone call MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Measure: Initial biological profile of children and adults with COVID-19 infection Time: Day 0Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
Measure: Initial immunological profile of children and adults with COVID-19 infection Time: Day 0Secondary Outcomes
Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection
Measure: Clinical worsening Time: Within 21 days following inclusionDescription: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening
Measure: Evolution of the immunological profile of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19 Time: Day 0Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.
Measure: Genetic profile of adults with COVID-19 infection Time: Day 0Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening
Measure: Genetic profile of adults with COVID-19 infection Time: Within 21 days following inclusion