|drug396||BI 1015550 Wiki||0.28|
|drug4129||supportive and symptomatic treatment Wiki||0.28|
|drug3930||intravenous immunoglobulin therapy Wiki||0.28|
|drug1358||Fuzheng Huayu Tablet Wiki||0.28|
|drug598||CHEST CT SCAN Wiki||0.28|
|drug610||COM-COVID anonimous survey Wiki||0.28|
|drug3675||Vitamin C tablets Wiki||0.28|
|drug3924||inhalable hydroxychloroquine (HCQ) Wiki||0.28|
|drug3589||Unsupervised exercise Wiki||0.28|
|drug3919||imaging, blood tests Wiki||0.28|
|drug2193||Nintedanib 150 MG [Ofev] Wiki||0.28|
|drug1217||Esomeprazole 20mg Wiki||0.28|
|drug1593||IN01 vaccine Wiki||0.28|
|drug595||CFTR Modulators Wiki||0.28|
|drug3432||Tezacaftor/Ivacaftor + Ivacaftor Wiki||0.28|
|drug28||20 Mg Prednisone for 14 days Wiki||0.28|
|drug4084||respiratory function rehabilitation training Wiki||0.28|
|drug2557||Placebo oral tablet Wiki||0.05|
|D003550||Cystic Fibrosis NIH||0.50|
|D011658||Pulmonary Fibrosis NIH||0.48|
|D055732||Pulmonary Aspergillosis NIH||0.28|
|D001229||Aspergillosis, Allergic Bronchopulmonary NIH||0.28|
|D008103||Liver Cirrhosis, NIH||0.28|
|D054990||Idiopathic Pulmonary Fibrosis NIH||0.20|
|D003141||Communicable Diseases NIH||0.02|
There are 13 clinical trials
People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur. Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function. The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.
Description: Time taken after eating for ingested food to be identifiable at the caecum on MRIMeasure: Oro-caecal Transit Time Time: 1 day of scanning
Description: Volume of stomach at each time point of digestion to measure gastric emptying timeMeasure: Gastric volume Time: 1 day of scanning
Description: Volume of water content in small bowel representing secretions and post prandial change in small bowel water content at T240 and T300Measure: Small bowel water content (corrected for body surface area) Time: 1 day of scanning
Description: Volume of colon representing ease of chyme passage through colonMeasure: Colonic volume (corrected for body surface area) Time: 1 day of scanning
Description: Gastrointestinal symptoms measured by patient reported outcomes to monitor relationships with outcomes measure by MRIMeasure: Gastrointestinal symptoms Time: 1 day of scanning
Description: Volume of sigmoid colonMeasure: Sigmoid colon volume Time: 1 day of scanning
Description: An approximate measure of water content in chyme present in the ascending colonMeasure: T1 relaxation of ascending colon chyme Time: 1 day of scanning
Description: A measure of fat content in chyme present in the ascending colonMeasure: Fat fraction of ascending colon chyme Time: 1 day of scanning
Description: A measure of elastase in stool to evaluate pancreatic functionMeasure: Faecal elastase Time: 1 day
Description: A measure of microbiome in sputum and stoolMeasure: Sputum and faecal microbiome Time: 1 day
Description: A measure of intestinal inflammationMeasure: Faecal calprotectin Time: 1 day
Description: A measure of motility at the terminal ileum using the GIQuant tool in arbitrary unitsMeasure: Terminal Ileum motility Time: 1 day
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
Description: Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.Measure: The improvement proportion of pulmonary fibrosis Time: Week 24
Description: Evaluation of Lung Function ImprovementMeasure: Blood oxygen saturation Time: Week 24
Description: Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19Measure: Clinical symptom score Time: Week 24
Description: This scale can reflect the quality of life of patients to some extent.Measure: Quality of Life-BREF (QOL-BREF) Time: Week 24
Description: This scale can reflect the quality of life of patients to some extent.Measure: Patient Health Questionnaire-9(PHQ-9) Time: Week 24
Description: This scale can reflect the quality of life of patients to some extent.Measure: Generalized anxiety disorder-7(GAD-7) Time: Week 24
Description: Evaluation of Lung Function ImprovementMeasure: The 6-minute walk distance Time: Week 24
COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosisMeasure: All-cause mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from any cause, up to 365 days
Description: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosisMeasure: Liver-related mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from liver-related cause, up to 365 days
Description: Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosisMeasure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis Time: From hospital admission to death, up to 365 days
Description: Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosisMeasure: Baseline characteristics of COVID-19 patients with liver cirrhosis Time: 1 Day
This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
Description: Changes in strength will be measured using a five repetition maximum test (5RM)Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week intervention
Description: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926SMeasure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week intervention
To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC). To investigate safety and tolerability of BI 1015550 in the overall trial population.
Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.
Description: Infection rates by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus-infection, Sars-CoV-2-infection)Measure: Infection rates differentiated by site Time: 360 days after randomization
Description: The gut microbiota composition will be analyzed by PCRMeasure: Changes of intestinal microbiota between baseline and day 90 Time: 90 days after randomization
Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),Measure: Cancellation or postponement of consultations by the health professional or patient, Time: Up to 6 months
Description: Number of consultations cancelled by the teleconsultation/replacement patient,Measure: Patient cancellation of teleconsultations/telecare replacement, Time: Up to 6 months
Description: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled), Time: Up to 6 months
Description: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration). Time: Up to 6 months
Description: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)Measure: The reduction of each of the elements of care provision and health care utilization: Time: Up to 6 months
Description: Intravenous instead of intravenous administrationMeasure: The change of modality of administration of antibiotic cures Time: Up to 6 months
Description: Questionnaire about taking or not taking treatment during confinementMeasure: Compliance Time: Up to 6 months
Description: Scale 0-21Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Time: Up to 6 months
Description: A questionnaire on the presence or absence of toxic consumptionMeasure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown Time: Up to 6 months
Description: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Time: Up to 6 months
Description: Role of social inequalities in the consequences of containment assessed by qualitative methodsMeasure: Assessing the role of social inequalities in the consequences of lockdown Time: Up to 6 months
Description: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosisMeasure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Time: Up to 6 months
This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.
Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.Measure: Difference in Th2 Sputum Markers Time: Average of 24 months
Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.Measure: Other markers of fungal inflammation and allergic reaction in patients with CF Time: Average of 24 months
Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.Measure: Biobanking of specimens Time: Average of 24 months
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients. The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections. The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy". In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods. The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).
SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing the acute respiratory distress syndrome, massive lung cell destruction and, as a plausible sequelae, pulmonary fibrosis in COVID-19 patients. Current focus has been on the development of novel immunosuppressant therapies, in order to control the cytokine storm in COVID-19 patients. Thus, the effect of steroids, intravenous immunoglobulin, non-steroidal immunosuppressants, selective cytokine blockade, JAK/STAT pathway inbhibition, and mesenchymal precursor cells have been evaluated. Based on the above information, we propose COLLAGEN-POLYVINYLPYRROLIDONE (Distinctive name: FibroquelMR, active substance: Collagen-polyvinylpyrrolidone, pharmaceutical form: intramuscular injectable solution, with sanitary registration No. 201M95 SSA IV and SSA code: 010 000 3999) as a potential drug for the downregulation of the cytokine storm. Polymerized type I collagen reduces the expression of IL-1β, IL-8, TNF-alpha, TGF-β1, IL-17, Cox-1, leukocyte adhesion molecules (ELAM-1, VCAM- 1 and ICAM-1), some other mediators of inflammation and increases the levels of IL-10 and the number of regulatory T cells. In addition, it promotes the mechanisms of inhibition of tissue fibrosis, without adverse effects in rheumatoid arthritis and osteoarthritis.
Description: It will be considered as primary outcome if the patients meet the first criterion, or 2 of the remaining 3: No oxygen required to maintain oxygen saturation more than 92%, Decrease in severity category from Table 1 by at least 1 level, or Reduction in the time of symptoms, by at least 30% compared to placebo and baseline, or recovery of at least 30% the number of lymphocytes compared to placebo and baseline.Measure: Clinical primary Outcome measure Time: 14 days
Description: It will be considered as secondary outcome if the patients meet the first criterion, or 2 of the remaining 3: significant decrease in serum IP-10 (at least 30% compared to placebo and baseline), since this chemokine is directly associated with the progression and severity of COVID-19, significant decrease in serum pro-inflammatory cytokines (TNF-a, IL-1β, IL-7, at least 30% compared to placebo and baseline), significant decrease in the percentage of circulating effector T cells (at least 30% compared to placebo and baseline), or significant improvement from computerized axial tomography at re-examination. This improvement is defined as: a decrease of at least 40% in parenchymal attenuation, the appearance of ground glass, nodular opacities, thickening of interlobular septa and / or thickening of bronchial walls.Measure: Immunological secondary outcome measure Time: 3 months
Methodology: This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection. Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination). The patients enrolled in the control arm of the study will receive standard of care. The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms. Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease. A translational substudy will be included. Objectives: Primary Objective ● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection. Secondary Objectives - To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection. - To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
Description: Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria and hematological alterations that are clinical relevant under physician criteria. Data will be presented as number of AEs classified by severity.Measure: Safety (Frequency/severity of AEs) Time: Through study completion, average 1 year
Description: blood oxygen levels will be measured by a pulse oximeterMeasure: Oxygen saturation Time: baseline and days 1, 14 (w2), 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52
Description: St George QoL questionnaire: Disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.Measure: Quality of life (QoL) Time: baseline and weeks 2, 12, 24, 36 and 52
Description: High-resolution CT to follow fibrotic pattern reviewed by a central radiologistMeasure: Fibrotic pulmonary extension (measured as the size of the lesions) Time: baseline and weeks, 12, 24, and 52
Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.
Description: Change in Forced Vital Capacity over 12 months assessed by Annual Rate of Decline in FVC in Overall PopulationMeasure: The primary objective is to assess whether nintedanib slows the progression of lung fibrosis in COVID-19 survivors as assessed by the decline in the forced vital capacity (FVC) over 12 months compared to placebo. Time: at inclusion and 12 months.
Description: Rate of decline in DLCO estimated by linear regression of DLCO from baseline to 12 months from DLCO measurement at inclusion, 6 and 12 monthsMeasure: compare the rate of decline of DLCO over 12 months Time: at inclusion, 6 and 12 months
Description: Absolute change from baseline in the Six-minute walk test (6MWT) at 12 monthsMeasure: compare exercise capacity at 12 months Time: at 12 months
Description: HRCT fibrosis score and HRCT fibrosis extension (visual and computer-based assessment) at inclusion and 12 monthsMeasure: compare high resolution CT (HRCT) lung opacities extension at 12 months Time: at inclusion and 12 months
Description: Absolute change from baseline in the total score on the St. George's Respiratory Questionnaire questionnaire at 12 monthsMeasure: compare change in health-related quality of life Time: at 12 months
Description: Absolute change from baseline in the Dyspnea score (Multidimensional Dyspnea Profile and mMRC score) at 3, 6, 9 and 12 monthsMeasure: compare the evolution of dyspnea over time Time: at 3, 6, 9 and 12 months
Description: The absolute change from baseline Hospital Anxiety and Depression score at 3, 6, 9 and 12 monthsMeasure: compare change in Depression and anxiety over time Time: at 3, 6, 9 and 12 months
Description: Biomarker assay (KL-6, NT-proBNP, CRP, D-dimers) at inclusion and 12 monthsMeasure: compare change in lung injury, pulmonary hypertension and inflammation biomarkers Time: at inclusion and 12 months
Description: Percentage of patients with a tricuspid regurgitation velocity > 2.5, 2.8 and 3.4 m/sec evaluated at baseline and at 12 months.Measure: pulmonary hypertension prevalence at inclusion and 12 months Time: at inclusion and 12 months
Description: MUC5B at risk allele detection at inclusionMeasure: association between genetic susceptibility (MUC5B polymorphism) and lung fibrosis in COVID-19 survivors Time: at inclusion
Description: Incidence of clinical or biological adverse events with nintedanib versus placebo over 12 monthsMeasure: safety of nintedanib Time: over 12 months
A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
Description: resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltratesMeasure: improved Time: 14 days
Data processed on September 26, 2020.
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