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D005355: Fibrosis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (29)


Name (Synonyms) Correlation
drug4052 respiratory function rehabilitation training Wiki 0.29
drug2189 Nintedanib Wiki 0.29
drug1588 IN01 vaccine Wiki 0.29
Name (Synonyms) Correlation
drug560 CHEST CT SCAN Wiki 0.29
drug4077 severity of lung involvement with COVID-19. Wiki 0.29
drug2191 Nintedanib 150 MG [Ofev] Wiki 0.29
drug4074 serum inflammatory biomarkers Wiki 0.29
drug34 20 Mg Prednisone for 14 days Wiki 0.29
drug4096 stem cells Wiki 0.29
drug4063 sample of blood and saliva Wiki 0.29
drug3186 Standard care delivered in the isolation hospitals. Wiki 0.29
drug4068 semen analysis Wiki 0.29
drug3800 control Wiki 0.29
drug3770 bovhyaluronidase azoxymer Wiki 0.29
drug1347 Fuzheng Huayu Tablet Wiki 0.29
drug798 Clungene rapid test cassette Wiki 0.29
drug3629 Vitamin C tablets Wiki 0.29
drug818 Collagen-Polyvinylpyrrolidone Wiki 0.29
drug3834 exercise capacity Wiki 0.29
drug3712 [18F]FP-R01-MG-F2 Wiki 0.29
drug3460 Tramadol Wiki 0.29
drug4099 survey Wiki 0.20
drug4070 serology Wiki 0.17
drug4064 self-administered questionnaire Wiki 0.17
drug1706 Interview Wiki 0.14
drug2730 Questionnaire Wiki 0.05
drug3430 Tocilizumab Wiki 0.05
drug3191 Standard of Care Wiki 0.04
drug2490 Placebo Wiki 0.04

Correlated MeSH Terms (11)


Name (Synonyms) Correlation
D011658 Pulmonary Fibrosis NIH 0.60
D003550 Cystic Fibrosis NIH 0.33
D015209 Cholangitis, Sclerosing NIH 0.29
Name (Synonyms) Correlation
D002761 Cholangitis NIH 0.20
D008103 Liver Cirrhosis, NIH 0.20
D054990 Idiopathic Pulmonary Fibrosis NIH 0.20
D017563 Lung Diseases, Interstitial NIH 0.15
D008171 Lung Diseases, NIH 0.12
D012120 Respiration Disorders NIH 0.06
D012140 Respiratory Tract Diseases NIH 0.06
D011014 Pneumonia NIH 0.03

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0002206 Pulmonary fibrosis HPO 0.60
HP:0030151 Cholangitis HPO 0.20
HP:0001395 Hepatic fibrosis HPO 0.20
Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 0.15
HP:0002088 Abnormal lung morphology HPO 0.13
HP:0002090 Pneumonia HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 12 clinical trials


1 Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT

NCT03183570
Conditions
  1. Idiopathic Pulmonary Fibrosis
  2. Primary Sclerosing Cholangitis
  3. Covid19 Pneumonia
Interventions
  1. Drug: [18F]FP-R01-MG-F2
MeSH:Cholangitis Cholangitis, Sclerosing Pneumonia Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis
HPO:Cholangitis Pneumonia Pulmonary fibrosis

Primary Outcomes

Description: The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver.

Measure: SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung

Time: an estimated average of 2 hours

Secondary Outcomes

Description: Blood samples for blood time-activity measurements taken at 1, 3, 5, 10, 30, and 60 minutes after tracer injection for tracer kinetic analysis. Tracer kinetic analysis shows radiopharmaceutical distribution from the blood to the tissues over time.

Measure: Time Activity Measurements

Time: an estimated average of 1 hours

Description: EKG data, vital signs and laboratory data collected before IV injection of [18F]FP-R01-MG-F2 and after completion of the scan will allow the investigators to evaluate the safety and tolerability of the radiopharmaceutical. This will be measured as the number of patients who successfully completed the study.

Measure: Incidence of Study Completion (Safety and Tolerability)

Time: an estimated average of 2 hours
2 The Efficacy of Treating Pulmonary Fibrosis and Pulmonary Function Injury in COVID-19 With the Fuzheng Huayu Tablets: a Multicenter Randomized Controlled Trial

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.

NCT04279197
Conditions
  1. Pulmonary Fibrosis Due to COVID-19
Interventions
  1. Drug: Fuzheng Huayu Tablet
  2. Drug: Vitamin C tablets
  3. Other: Placebo
  4. Other: respiratory function rehabilitation training
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

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

Secondary Outcomes

Description: Evaluation of Lung Function Improvement

Measure: 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-19

Measure: 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 Improvement

Measure: The 6-minute walk distance

Time: Week 24
3 Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study

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.

NCT04329559
Conditions
  1. COVID-19
  2. Liver Cirrhosis
MeSH:Liver Cirrhosis Fibrosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis

Measure: 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

Secondary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis

Measure: 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 cirrhosis

Measure: 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 cirrhosis

Measure: Baseline characteristics of COVID-19 patients with liver cirrhosis

Time: 1 Day
4 Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

NCT04463628
Conditions
  1. Cystic Fibrosis in Children
  2. Cystic Fibrosis
Interventions
  1. Behavioral: Questionnaire
  2. Behavioral: Interview
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

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

Secondary Outcomes

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 administration

Measure: The change of modality of administration of antibiotic cures

Time: Up to 6 months

Description: Questionnaire about taking or not taking treatment during confinement

Measure: Compliance

Time: Up to 6 months

Description: Scale 0-21

Measure: 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 consumption

Measure: 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 methods

Measure: 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 fibrosis

Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.

Time: Up to 6 months
5 Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

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,...).

NCT04483752
Conditions
  1. CoV2 SARS Pneumonia
Interventions
  1. Other: CHEST CT SCAN
MeSH:Pneumonia Fibrosis
HPO:Pneumonia

Primary Outcomes

Measure: description of the different types of lesions

Time: 3 months

Secondary Outcomes

Measure: quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae

Time: 3 months
6 Effect of Collagen-Polyvinylpyrrolidone for the Treatment of Hyperinflammation and the Pulmonary Fibrosis in COVID-19 Patients. Double Blind Placebo-controlled Pilot Trial

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.

NCT04517162
Conditions
  1. Covid19
  2. Cytokine Storm
  3. Regulation of Inflammatory Response
  4. Pulmonary Fibrosis
Interventions
  1. Drug: Collagen-Polyvinylpyrrolidone
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

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

Secondary Outcomes

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
7 Phase Ib Controlled Exploratory Trial for Treatment of Fibrosing Interstitial Lung Disease Patients Secondary to SARS-CoV-2 Infection With IN01 Vaccine (COVINVAC)

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.

NCT04537130
Conditions
  1. Pulmonary Fibrosis
  2. Covid19
Interventions
  1. Biological: IN01 vaccine
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

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

Secondary Outcomes

Description: blood oxygen levels will be measured by a pulse oximeter

Measure: 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 radiologist

Measure: Fibrotic pulmonary extension (measured as the size of the lesions)

Time: baseline and weeks, 12, 24, and 52
8 "Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis"

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.

NCT04541680
Conditions
  1. SARS-Cov-2 Induced Pulmonary Fibrosis
Interventions
  1. Drug: Nintedanib 150 MG [Ofev]
  2. Other: Placebo
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

Description: Change in Forced Vital Capacity over 12 months assessed by Annual Rate of Decline in FVC in Overall Population

Measure: 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.

Secondary Outcomes

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 months

Measure: 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 months

Measure: 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 months

Measure: 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 months

Measure: 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 months

Measure: 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 months

Measure: 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 months

Measure: 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 inclusion

Measure: 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 months

Measure: safety of nintedanib

Time: over 12 months
9 Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis

A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

NCT04551781
Conditions
  1. Covid19
Interventions
  1. Drug: 20 Mg Prednisone for 14 days
  2. Drug: control
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

Description: resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates

Measure: improved

Time: 14 days
10 Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis

This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.

NCT04619680
Conditions
  1. Pulmonary Fibrosis
  2. Interstitial Lung Disease
  3. Respiratory Disease
Interventions
  1. Drug: Nintedanib
  2. Drug: Placebo
MeSH:Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial Respiration Disorders Respiratory Tract Diseases Fibrosis
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pulmonary fibrosis

Primary Outcomes

Description: Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.

Measure: Change in Forced Vital Capacity (FVC)

Time: Baseline and 180 days

Secondary Outcomes

Description: Death within 90 days and 180 days from enrollment due to a respiratory cause

Measure: Number of deaths due to respiratory cause

Time: within 90-180 days

Description: Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.

Measure: Chest CT visual score

Time: 180 days

Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.

Measure: St. George's Respiratory Questionnaire (SGRQ)

Time: Day 90

Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.

Measure: St. George's Respiratory Questionnaire (SGRQ)

Time: Day 180

Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.

Measure: King's Brief Interstitial Lung Disease (KBILD)

Time: Day 90

Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.

Measure: King's Brief ILD (KBILD)

Time: Day 180

Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.

Measure: Leicester Cough Questionnaire (LCQ)

Time: Day 90

Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.

Measure: Leicester Cough Questionnaire

Time: Day 180

Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.

Measure: Short Form (SF) 36 Health Survey

Time: Day 90

Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.

Measure: SF 36 Health Survey

Time: Day 180

Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 90

Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 180

Description: Number of participants with Increase in liver transaminases

Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal

Time: day 90

Description: Number of participants with Increase in liver transaminases

Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal

Time: day 180

Description: Number of participants with Thrombotic events: venous or arterial thrombosis

Measure: Number of participants with Thrombotic events

Time: day 90

Description: Number of participants with Thrombotic events: venous or arterial thrombosis

Measure: Number of participants with Thrombotic events

Time: day 180

Description: Number of participants with 10% weight loss

Measure: Number of participants with 10% weight loss over 90 days

Time: day 90

Description: Number of participants with 10% weight loss

Measure: Number of participants with 10% weight loss over 90 days

Time: day 180

Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents

Measure: Number of participants with GI events

Time: day 90

Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents

Measure: Number of participants with GI events

Time: day 180
11 Multicenter, Open-label Prospective Cohort Study of the Efficacy and Safety of the Inclusion of Longidaze in the Prevention and Treatment of Post-inflammatory Pulmonary Fibrosis and Interstitial Lung Diseases Caused by COVID-19.

A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease following COVID-19.

NCT04645368
Conditions
  1. Fibroses, Pulmonary
Interventions
  1. Drug: bovhyaluronidase azoxymer
MeSH:Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial Fibrosis
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pulmonary fibrosis

Primary Outcomes

Description: The severity of pulmonary tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group according to the results of a blinded central laboratory

Measure: The severity of lung tissue lesions with fibrosis and interstitial changes on day 75

Time: Day 0, Day 75

Secondary Outcomes

Description: The severity of lung tissue damage by fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 6 months in relation to the baseline values of the indicator in patients of the Longidaze® group in comparison with the the dynamic observation group (according to the results of a blinded central laboratory)

Measure: The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180

Time: Day 0, Day 180

Description: The severity of lung tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group (according to the results of the local laboratory)

Measure: The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180

Time: Day 0, Day 75, Day 180

Description: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) based on the high-resolution computed tomography images analyzed by the Botkin.AI program (artificial intelligence) and then verified by a specialist after 2.5 months and 6 months from the beginning of observation in relation to the baseline values of indicators in patients of the Longidaze® group in comparison with the dynamic observation group

Measure: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) images analyzed by the Botkin.AI program (artificial intelligence)

Time: Day 75, Day 180

Description: Change in forced vital capacity FVC (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group

Measure: Change in forced vital capacity (FVC)

Time: Day 0, Day 75, Day 180

Description: Change in the diffusion capacity of the lungs (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group

Measure: Change in the diffusion capacity of the lungs

Time: Day 0, Day 75, Day 180

Description: Change in the degree of dyspnea on the MMRC scale from baseline after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. MMRC scale (Modified Medical Research Council scale) 0 - no - Dyspnea does not bother, except for very intense exercise - mild - Shortness of breath bothers with brisk walking or climbing a small elevation - moderate to severe - Shortness of breath results in slower walking compared to other people of the same age, or need to stop while walking at normal pace on a level surface - Severe - Shortness of breath makes you stop when walking about 100 m or after a few minutes of walking on a flat surface - very severe - Shortness of breath makes it impossible to leave the house or appears when dressing and undressing

Measure: Change in the degree of dyspnea on the MMRC scale

Time: Day 0, Day 75, Day 180

Description: Changes in SpO2 of capillary blood relative to the initial value after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.

Measure: Changes in capillary blood oxygen saturation (SpO2)

Time: Day 0, Day 75, Day 180

Description: Changes in the covered footage in the 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.

Measure: Changes in the covered footage in the 6-minute walk test

Time: Day 0, Day 75, Day 180

Description: Changes in capillary blood saturation (SpO2) after a 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.

Measure: Changes in capillary blood saturation (SpO2) after a 6-minute walk test

Time: Day 0, Day 75, Day 180

Description: Change in the residual volume of the lungs after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.

Measure: Change in the residual volume of the lungs

Time: Day 0, Day 75

Description: Change in the total lung capacity after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.

Measure: Change in the total lung capacity

Time: Day 0, Day 75

Description: Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group

Measure: Change in inspiratory capacity

Time: Day 75
12 Comparison of Physical Activity, Exercise Capacity, Quality of Life, Cognitive Function and Coronavirus Phobia Levels of Adult Cystic Fibrosis Patients With Healthy Individuals With Telerehabilitation in the COVID-19 Pandemic

The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic.

NCT04673331
Conditions
  1. Cystic Fibrosis
Interventions
  1. Other: exercise capacity
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Physical activity level will be evaluated International Physical Activity Questionnaire- Short Form (IPAQ-SF). IPAQ short version asks spended time during sitting, walking, moderate and vigorous physical activities. The score is obtained by multiplying the minutes, days and metabolic equivalent values. According to these scores, physical activity levels are classified as "inactive", "minimally active" and "very active".

Measure: Physical Activity Level-International Physical Activity Questionnaire

Time: 8 minutes

Description: COVID-19 phobia will be evaluated with Coronavirus-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome.

Measure: Coronavirus Phobia-Coronavirus-19 Phobia Scale

Time: 5 minutes

Description: Exercise capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. Maximum heart rate, minimum saturation, count of step are record during the 3 minute step test. Number of sit to stand for 1 minute is recorded end of the 1 minute sit to stand test.

Measure: Exercise Capacity

Time: 15 minutes

Description: The number of steps in the last week was recorded and averaged using the pedometer applications from the participants own smartphones. <5000 steps/day sedentary 5000-7499 steps/day low active 7500-9999 steps/day somewhat active ≥10 000 steps/day active >12 500 steps/day highly active

Measure: Weekly Average Steps

Time: 2 minutes

Secondary Outcomes

Description: Cognitive function evaluation will be Standardized Mini Mental State Examination (SMMSE). Scores less than 23 mean cognitive impairment.

Measure: Cognitive Function-Standardized Mini Mental State Examination

Time: 5 minutes

Description: Quality of life will be evaluated with Nottingham Health Profile (NHP). This questionnaire categorizes are energy, pain, emotional reactions, sleep, social isolation, physical mobility, depression and anxiety. Lower scores mean better outcome.

Measure: Quality Of Life-Nottingham Health Profile

Time: 10 minutes

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