Covid 19 Research using Clinical Trials (Home Page)
Report for D012140: Respiratory Tract Diseases NIH
(Synonyms: Respiratory T, Respiratory Tract Dis, Respiratory Tract Dise, Respiratory Tract Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (20)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug215 | Breath test Wiki | 0.30 |
| drug1261 | Sputum and blood sampling Wiki | 0.30 |
| drug80 | Angiotensin Receptor Blockers Wiki | 0.30 |
| drug676 | Inhaled Hypertonic ibuprofen Wiki | 0.30 |
| drug896 | Nitric Oxide delivered via LungFit™ system Wiki | 0.30 |
| drug746 | Linagliptin 5 MG Wiki | 0.30 |
| drug1450 | Urine sample Wiki | 0.30 |
| drug470 | End tidal breath sample Wiki | 0.30 |
| drug1374 | Tests Wiki | 0.30 |
| drug13 | 1: Usual practice Wiki | 0.30 |
| drug20 | 2: Usual practice + SYMBICORT RAPIHALER Wiki | 0.30 |
| drug1262 | Sputum sample Wiki | 0.30 |
| drug276 | CYNK-001 Wiki | 0.30 |
| drug525 | Follow up Wiki | 0.21 |
| drug403 | Data collection Wiki | 0.17 |
| drug876 | Nasopharyngeal swab Wiki | 0.17 |
| drug1607 | no intervention Wiki | 0.17 |
| drug203 | Blood sample Wiki | 0.13 |
| drug591 | Hydroxychloroquine Wiki | 0.03 |
| drug1016 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (22)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012120 | Respiration Disorders NIH | 0.85 |
| D030341 | Nidovirales Infections NIH | 0.30 |
| D008659 | Metabolic Diseases NIH | 0.30 |
| D004700 | Endocrine System Diseases NIH | 0.30 |
| D044882 | Glucose Metabolism Disorders NIH | 0.30 |
| D007154 | Immune System Diseases NIH | 0.21 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.17 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.15 |
| D053120 | Respiratory Aspiration NIH | 0.15 |
| D003333 | Coronaviridae Infections NIH | 0.15 |
| D012327 | RNA Virus Infections NIH | 0.15 |
| D003920 | Diabetes Mellitus, NIH | 0.13 |
| D008173 | Lung Diseases, Obstructive NIH | 0.12 |
| D008171 | Lung Diseases, NIH | 0.11 |
| D011024 | Pneumonia, Viral NIH | 0.08 |
| D014777 | Virus Diseases NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.07 |
| D012141 | Respiratory Tract Infections NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.06 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.05 |
| D007239 | Infection NIH | 0.04 |
Correlated HPO Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000818 | Abnormality of the endocrine system HPO | 0.30 |
| HP:0000819 | Diabetes mellitus HPO | 0.17 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.17 |
| HP:0006510 | Chronic obstructive pulmonary disease HPO | 0.17 |
| HP:0006536 | Obstructive lung disease HPO | 0.13 |
| HP:0002088 | Abnormal lung morphology HPO | 0.12 |
| HP:0011947 | Respiratory tract infection HPO | 0.07 |
| HP:0002090 | Pneumonia HPO | 0.07 |
There are 11 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 Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents
This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning. At the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants. The study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants. During the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed. Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza. The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees. The investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.
NCT01486160 Acute Viral Respiratory Tract Diseases MeSH:Virus Diseases Respiratory Tract Diseases
Primary Outcomes
Description: Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified
Measure: Number of viral respiratory tract infection in participants according to etiology Time: 6 monthsSecondary Outcomes
Description: Serum concentration of vitamine D will be measured retrospectively from the blood samples taken at the beginning of the study and correlation between vitamine D concentration and the frequency of respiratory tract infection in participants will be made
Measure: Serum vitamine D concentration in participants Time: 6 monthsDescription: Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.
Measure: Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents Time: 6 months3 Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.
NCT03151395 Respiratory Disorders Other: Sputum and blood sampling MeSH:Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases
HPO:Chronic obstructive pulmonary disease Obstructive lung disease
Primary Outcomes
Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.
Measure: Occurrence of potential bacterial in sputum of stable COPD patients. Time: Over the course of 1 year
Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.
Measure: Occurrence of potential bacterial in sputum during AECOPD. Time: Over the course of 1 year
Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.
Measure: Occurrence of viral pathogens in sputum of stable COPD patients. Time: Over the course of 1 year
Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.
Measure: Occurrence of viral pathogens in sputum during AECOPD. Time: Over the course of 1 year
Secondary Outcomes
Description: Including (but not necessarily limited to) H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus and P. aeruginosa.
The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens by PCR will be computed with 95% confidence intervals.
Measure: Occurrence of potential bacterial pathogens in sputum of stable COPD patients and during AECOPD, as measured by real-time qualitative PCR/ quantitative PCR and compared to data from bacteriological methods. Time: Over the course of 1 year
Description: The proportion of sputum samples obtained at each AECOPD visit and positive for specific bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial/viral species) will be computed with 95% confidence intervals by any severity (mild, moderate and severe).
Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum during AECOPD by severity of AECOPD. Time: Over the course of 1 year
Description: The proportion of sputum samples obtained at each confirmed stable visit and positive for bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial / viral species) will be computed with 95% confidence intervals by Gold grade at enrolment.
Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum of stable COPD patients by GOLD grade. Time: Over the course of 1 year
Description: The following incidence rates will be computed, with 95% confidence intervals (CI):
All-cause AECOPD.
AECOPD having sputum containing bacterial pathogens found by PCR or by bacteriological methods or by both methods (overall and by, but not limited to, the following bacterial species: H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, and P. aeruginosa).
The 95% CI of the incidence rate will be computed using a model which accounts for repeated events. The incidence rates described above will also be computed for mild, moderate severe AECOPD and by GOLD grade at enrolment.
Measure: Incident rate (per subject per year) of any AECOPD overall and by GOLD grade. Time: Over the course of 1 year
Description: Classification of severity according to the intensity of medical intervention required:
mild: controlled with an increase in dosage of regular medications;
moderate: requires treatment with systemic corticosteroids and/ or antibiotics;
severe: requires hospitalisation.
Measure: Number of mild, moderate or severe AECOPD overall and by GOLD grade. Time: Over the course of 1 year
Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the number of days of AECOPD episodes will be presented.
Measure: Number of days of AECOPD episodes overall and by AECOPD severity. Time: Over the course of 1 year
Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the CAT scores will be tabulated at each respective visit.
Measure: COPD assessment test (CAT) score in stable COPD patients and during AECOPD. Time: Over the course of 1 year
Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the SGRQ-C scores will be tabulated at each respective visit.
Measure: St. George's Respiratory Questionnaire (SGRQ-C) score in stable COPD patients. Time: Over the course of 1 year
Description: The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator FEV1.
Summary statistics (mean, median, standard deviation, maximum and minimum) on post bronchodilator FEV1% of predicted normal value will be tabulated at each respective visit.
Measure: Forced expiratory volume in 1 second (FEV1%) of predicted normal value in stable COPD patients. Time: At Pre-Month 0 and Month 12
Description: Healthcare use for each COPD patient will be obtained through review of the subject's medical record (aided by subject self-reporting). Healthcare utilisation includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations.
Measure: Assessment of the Healthcare utilization. Time: Over the course of 1 year
4 Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)
Primary Outcomes
Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.
Measure: Occurrence of potential bacterial in sputum of stable COPD patients. Time: Over the course of 1 yearDescription: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.
Measure: Occurrence of potential bacterial in sputum during AECOPD. Time: Over the course of 1 yearDescription: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.
Measure: Occurrence of viral pathogens in sputum of stable COPD patients. Time: Over the course of 1 yearDescription: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.
Measure: Occurrence of viral pathogens in sputum during AECOPD. Time: Over the course of 1 yearSecondary Outcomes
Description: Including (but not necessarily limited to) H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus and P. aeruginosa. The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens by PCR will be computed with 95% confidence intervals.
Measure: Occurrence of potential bacterial pathogens in sputum of stable COPD patients and during AECOPD, as measured by real-time qualitative PCR/ quantitative PCR and compared to data from bacteriological methods. Time: Over the course of 1 yearDescription: The proportion of sputum samples obtained at each AECOPD visit and positive for specific bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial/viral species) will be computed with 95% confidence intervals by any severity (mild, moderate and severe).
Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum during AECOPD by severity of AECOPD. Time: Over the course of 1 yearDescription: The proportion of sputum samples obtained at each confirmed stable visit and positive for bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial / viral species) will be computed with 95% confidence intervals by Gold grade at enrolment.
Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum of stable COPD patients by GOLD grade. Time: Over the course of 1 yearDescription: The following incidence rates will be computed, with 95% confidence intervals (CI): All-cause AECOPD. AECOPD having sputum containing bacterial pathogens found by PCR or by bacteriological methods or by both methods (overall and by, but not limited to, the following bacterial species: H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, and P. aeruginosa). The 95% CI of the incidence rate will be computed using a model which accounts for repeated events. The incidence rates described above will also be computed for mild, moderate severe AECOPD and by GOLD grade at enrolment.
Measure: Incident rate (per subject per year) of any AECOPD overall and by GOLD grade. Time: Over the course of 1 yearDescription: Classification of severity according to the intensity of medical intervention required: mild: controlled with an increase in dosage of regular medications; moderate: requires treatment with systemic corticosteroids and/ or antibiotics; severe: requires hospitalisation.
Measure: Number of mild, moderate or severe AECOPD overall and by GOLD grade. Time: Over the course of 1 yearDescription: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the number of days of AECOPD episodes will be presented.
Measure: Number of days of AECOPD episodes overall and by AECOPD severity. Time: Over the course of 1 yearDescription: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the CAT scores will be tabulated at each respective visit.
Measure: COPD assessment test (CAT) score in stable COPD patients and during AECOPD. Time: Over the course of 1 yearDescription: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the SGRQ-C scores will be tabulated at each respective visit.
Measure: St. George's Respiratory Questionnaire (SGRQ-C) score in stable COPD patients. Time: Over the course of 1 yearDescription: The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator FEV1. Summary statistics (mean, median, standard deviation, maximum and minimum) on post bronchodilator FEV1% of predicted normal value will be tabulated at each respective visit.
Measure: Forced expiratory volume in 1 second (FEV1%) of predicted normal value in stable COPD patients. Time: At Pre-Month 0 and Month 12Description: Healthcare use for each COPD patient will be obtained through review of the subject's medical record (aided by subject self-reporting). Healthcare utilisation includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations.
Measure: Assessment of the Healthcare utilization. Time: Over the course of 1 yearOn Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help. This study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.
NCT04329507 COVID-19 Respiratory Disease Diagnostic Test: Breath test MeSH:Pneumonia Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia
Primary Outcomes
Description: breath sample collection
Measure: To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without. Time: up to daily during hospital admission
Secondary Outcomes
Description: breath sample collection
Measure: Detection of markers of Covid-19 pneumonia in non-invasive breath samples. Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue
Description: breath sample collection
Measure: Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs. Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue
Description: breath sample collection
Measure: Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue
Description: breath sample collection
Measure: In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden . Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue
5 Protective Role of Inhaled Steroids for Covid-19 Infection
Primary Outcomes
Description: breath sample collection
Measure: To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without. Time: up to daily during hospital admissionSecondary Outcomes
Description: breath sample collection
Measure: Detection of markers of Covid-19 pneumonia in non-invasive breath samples. Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continueDescription: breath sample collection
Measure: Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs. Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continueDescription: breath sample collection
Measure: Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continueDescription: breath sample collection
Measure: In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden . Time: daily until the patient has ben discharged from hospital or it is deemed inappropriate to continueWe hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.
NCT04331054 Covid-19 Infection Hospitalization in Respiratory Disease Department Drug: 2: Usual practice + SYMBICORT RAPIHALER Other: 1: Usual practice MeSH:In Infection Communicable Diseases Respiration Disorders Respiratory Tract Diseases
Primary Outcomes
Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.
Measure: Time (in days) to clinical improvement within 30 days after randomization Time: within 30 daysSecondary Outcomes
Measure: Mortality rate at D30 Time: At day30Measure: Time (in days) from randomization to death Time: up to 30 days after randomization
Measure: Number of days alive outside ICU within 30 days Time: At day30
Measure: Number of days alive free of invasive or non-invasive ventilation within 30 days Time: At day30
Measure: Number of days alive with oxygen therapy within 30 days Time: At day30
Measure: Maximal oxygen rate within 30 days Time: At day30
Measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7) Time: at Day 7
Measure: Number of days alive outside hospital within 30 days Time: at Day 30
Measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days Time: at Day 30
Measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) Time: at Day 7
Measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. Time: up to 30 days after randomization
6 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.
NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001 MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection
Primary Outcomes
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 months
Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 12 months
Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score or radiologic evaluation as measured by protocol-defined radiologic evaluation score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 12 months
Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 days
Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 days
Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by Radiologic Evaluation Score.
Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score Time: Up to 28 days
Secondary Outcomes
Description: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 months
Description: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 months
Description: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 months
Description: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 months
Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 days
Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 days
Description: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough Time: Up to 28 days
Description: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 days
Description: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 days
Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 months
7 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Primary Outcomes
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score or radiologic evaluation as measured by protocol-defined radiologic evaluation score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by Radiologic Evaluation Score.
Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score Time: Up to 28 daysSecondary Outcomes
Description: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 monthsThe coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
NCT04371978 COVID 19 Coronavirus Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Dipeptidyl-Peptidase IV Inhibitors Linagliptin Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Hypoglycemic Agents Respiratory Tract Diseases Inc Incretins Hormones Drug: Linagliptin 5 MG MeSH:Coronaviru Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Respiratory Tract Diseases Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Type II diabetes mellitus
Primary Outcomes
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 days
Secondary Outcomes
Measure: Percent of serious adverse events and premature discontinuation of treatment. Time: 28 days
Description: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 days
Measure: Length of hospitalization. Time: 28 days
Measure: All-cause mortality. Time: 28 days
Measure: Percent of supplemental oxygen use. Time: 28 days
Measure: Supplemental oxygen-free days. Time: 28 days
Measure: Percent of mechanical ventilation use. Time: 28 days
Measure: Ventilator-free days. Time: 28 days
Measure: Percent of ICU admissions. Time: 28 days
Measure: ICU-free days. Time: 28 days
Measure: Percent of 50% decrease in C-reactive protein (CRP) levels Time: Up to 28 days
Measure: Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test. Time: 28 days
8 Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
Primary Outcomes
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 daysSecondary Outcomes
Measure: Percent of serious adverse events and premature discontinuation of treatment. Time: 28 daysDescription: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 daysMeasure: Length of hospitalization. Time: 28 days
Measure: All-cause mortality. Time: 28 days
Measure: Percent of supplemental oxygen use. Time: 28 days
Measure: Supplemental oxygen-free days. Time: 28 days
Measure: Percent of mechanical ventilation use. Time: 28 days
Measure: Ventilator-free days. Time: 28 days
Measure: Percent of ICU admissions. Time: 28 days
Measure: ICU-free days. Time: 28 days
Measure: Percent of 50% decrease in C-reactive protein (CRP) levels Time: Up to 28 days
Measure: Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test. Time: 28 days
The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.
NCT04382768 Coronavirus Infection Respiratory Disease SARS (Disease) Drug: Inhaled Hypertonic ibuprofen MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases
Primary Outcomes
Description: Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale
Measure: Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen. Time: 7, 14 and 28 daysDescription: Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. Time: 7, 14 and 28 daysSecondary Outcomes
Measure: Chage in length of Hospital stay Time: 28 daysMeasure: Chage in duration of ventilation Time: 28 days
Measure: Chage in length of Critical Care stay Time: 28 days
Description: NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care.
Measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. Time: 1, 7, 14 and 28Description: qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not.
Measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. Time: 1, 7, 14 and 28 daysMeasure: Time from first dose to conversion to normal or mild pneumonia Time: 28 days
Measure: Antibiotic requirement Time: 28 days
Measure: Glucocorticoids requirement Time: 28 days
Measure: Incidence of adverse event Time: 28 days
Measure: Incidence of serious adverse event Time: 28 days
Measure: Number of deaths from any cause at 28 days Time: 28 days
Measure: Lymphocyte count Time: 28 days
9 Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease
The Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.
NCT04394117 SARS-Cov-2 COVID-19 Drug: Angiotensin Receptor Blockers MeSH:Respiration Disorders Respira Respiratory Tract Diseases
Primary Outcomes
Description: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;
Measure: 7-Point National Institute of Health Clinical Health Score Time: 28 DaysSecondary Outcomes
Description: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;
Measure: 7-Point National Institute of Health Clinical Health Score Time: 15 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Measure: Mortality Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Measure: Mortality Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Measure: Intensive Care Unit Admission Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Measure: Intensive Care Unit Admission Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of days total, of intensive care unit admission
Measure: Intensive Care Unit Admission Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the incidence of respiratory failure
Measure: Respiratory Failure Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the requirements for dialysis
Measure: Dialysis Requirement Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Measure: Hospitalisation Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Measure: Hospitalisation Days Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes need for ventilation
Measure: Ventilator-Free Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes need for dialysis
Measure: Dialysis Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes risk of acute kidney injury, based on the idney Disease: Improving Global Outcomes definition
Measure: Acute Kidney Injury Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes risk of hypotension requiring vasopressors
Measure: Hypotension Requiring Vasopressors Time: 90 Days10 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
NCT04397692 Corona Virus Infection COVID-19 SARS-CoV 2 Nitric Oxide Respiratory Disease Pneumonia, Viral Inhaled Nitric Oxide Device: Nitric Oxide delivered via LungFit™ system MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia
Primary Outcomes
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 Days
Secondary Outcomes
Description: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 Days
Description: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 Days
Description: Time to intubation
Measure: Time to intubation Time: 14 days
Description: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% Time: 14 days
Other Outcomes
Description: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 days
Description: Change in viral load
Measure: Change in viral load Time: 30 days
Description: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 days
Description: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 days
11 Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms
Primary Outcomes
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysSecondary Outcomes
Description: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 DaysDescription: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 DaysDescription: Time to intubation
Measure: Time to intubation Time: 14 daysDescription: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% Time: 14 daysOther Outcomes
Description: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 daysDescription: Change in viral load
Measure: Change in viral load Time: 30 daysDescription: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 daysDescription: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 daysA new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known. The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form. This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.
NCT04407169 COVID Other: no intervention MeSH:Respiration Disorders Respiratory Tract Diseases
Primary Outcomes
Description: Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.
Measure: Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale Time: up to 28 days (during hospitalisation)Secondary Outcomes
Description: Radiological damage (extension of ground-glass) could be a predictive factor.
Measure: Determined potential predictive factors of critic form in patients with chronic lung diseases Time: up to 28 days (during hospitalisation)Description: intra-hospital death, intra-ICU death
Measure: Determined percentage of death Time: up to 28 days (during hospitalisation)Description: in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)
Measure: Determined duration of oxygen therapy Time: up to 28 days (during hospitalisation)Description: in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.
Measure: Determined duration of hospitalization Time: up to 28 days (during hospitalisation)Description: values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement
Measure: Determine mean values of the WHO CoVid-19 infection progression scale measured Time: up to 28 days (during hospitalisation)