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  • HP:0002206: Pulmonary fibrosis
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    HP:0002206: Pulmonary 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 (39)


    Name (Synonyms) Correlation
    drug4037 survey Wiki 0.37
    drug3180 Sterile Normal Saline for Intravenous Use Wiki 0.26
    drug2152 Nintedanib 150 MG [Ofev] Wiki 0.26
    Name (Synonyms) Correlation
    drug4006 semen analysis Wiki 0.26
    drug3710 bovhyaluronidase azoxymer Wiki 0.26
    drug2151 Nintedanib 150 MG Wiki 0.26
    drug1553 IN01 vaccine Wiki 0.26
    drug710 Centricyte 1000 Wiki 0.26
    drug2653 Pulmonary function tests Wiki 0.26
    drug34 20 Mg Prednisone for 14 days Wiki 0.26
    drug781 Clungene rapid test cassette Wiki 0.26
    drug3573 Vitamin C tablets Wiki 0.26
    drug2000 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.26
    drug1642 Interferon-Alpha2B Wiki 0.26
    drug2150 Nintedanib Wiki 0.26
    drug1583 Imaging Wiki 0.26
    drug875 Convalescent Serum Wiki 0.26
    drug800 Collagen-Polyvinylpyrrolidone Wiki 0.26
    drug367 BIO 300 Oral Suspension Wiki 0.26
    drug4015 severity of lung involvement with COVID-19. Wiki 0.26
    drug1518 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 0.26
    drug1562 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.26
    drug3740 control Wiki 0.26
    drug1517 Hydroxychloroquine, Clindamycin Wiki 0.26
    drug3990 respiratory function rehabilitation training Wiki 0.26
    drug4034 stem cells Wiki 0.26
    drug3654 [18F]FP-R01-MG-F2 Wiki 0.26
    drug1516 Hydroxychloroquine, Azithromycin Wiki 0.26
    drug1519 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 0.26
    drug1780 Liberase Enzyme (Roche) Wiki 0.26
    drug1316 Fuzheng Huayu Tablet Wiki 0.26
    drug1520 Hydroxychloroquine, Doxycycline Wiki 0.26
    drug2447 Pirfenidone Wiki 0.18
    drug481 Blood sampling Wiki 0.09
    drug1824 Losartan Wiki 0.09
    drug2448 Placebo Wiki 0.07
    drug1995 Methylprednisolone Wiki 0.07
    drug2782 Remdesivir Wiki 0.04
    drug3375 Tocilizumab Wiki 0.04

    Correlated MeSH Terms (16)


    Name (Synonyms) Correlation
    D011658 Pulmonary Fibrosis NIH 1.00
    D005355 Fibrosis NIH 0.60
    D054990 Idiopathic Pulmonary Fibrosis NIH 0.37
    Name (Synonyms) Correlation
    D017563 Lung Diseases, Interstitial NIH 0.28
    D011649 Pulmonary Alveolar Proteinosis NIH 0.26
    D015209 Cholangitis, Sclerosing NIH 0.26
    D008171 Lung Diseases, NIH 0.22
    D002761 Cholangitis NIH 0.18
    D012120 Respiration Disorders NIH 0.06
    D012140 Respiratory Tract Diseases NIH 0.05
    D011024 Pneumonia, Viral NIH 0.03
    D003141 Communicable Diseases NIH 0.02
    D011014 Pneumonia NIH 0.01
    D007239 Infection NIH 0.01
    D045169 Severe Acute Respiratory Syndrome NIH 0.01
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (5)


    Name (Synonyms) Correlation
    HP:0006515 Interstitial pneumonitis HPO 0.28
    HP:0006517 Intraalveolar phospholipid accumulation HPO 0.26
    HP:0002088 Abnormal lung morphology HPO 0.23
    Name (Synonyms) Correlation
    HP:0030151 Cholangitis HPO 0.18
    HP:0002090 Pneumonia HPO 0.01

    Clinical Trials

    Navigate: Correlations   HPO

    There are 15 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 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

    COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

    NCT04326036
    Conditions
    1. Pulmonary Alveolar Proteinosis
    2. COPD
    3. Idiopathic Pulmonary Fibrosis
    4. Viral Pneumonia
    5. Coronavirus Infection
    6. Interstitial Lung Disease
    Interventions
    1. Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
    2. Device: Centricyte 1000
    3. Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
    4. Drug: Liberase Enzyme (Roche)
    5. Drug: Sterile Normal Saline for Intravenous Use
    MeSH:Infection Communicable Diseases Coron Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
    HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Intraalveolar phospholipid accumulation Pulmonary fibrosis

    Primary Outcomes

    Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

    Measure: Incidence of Treatment-Emergent Adverse Events

    Time: 1 month

    Secondary Outcomes

    Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

    Measure: Pulmonary Function Analysis

    Time: baseline, 3 Month, 6 months

    Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

    Measure: Digital Oximetry

    Time: 3 months, 6 months
    4 Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study

    This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

    NCT04338802
    Conditions
    1. COVID-19
    2. Nintedanib
    3. Safety
    4. Effect of Drugs
    Interventions
    1. Drug: Nintedanib 150 MG
    2. Other: Placebo
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Changes in forced vital capacity (FVC) after treatment compared to baseline.

    Measure: Changes in forced vital capacity (FVC)

    Time: 8 weeks

    Secondary Outcomes

    Description: Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.

    Measure: Changes in carbon monoxide dispersion (DLco%)

    Time: 8 weeks

    Description: Changes in the six-minute walk test (6MWT) after treatment compared to baseline.

    Measure: Changes in the six-minute walk test (6MWT)

    Time: 8 weeks

    Description: Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result

    Measure: Changes in High resolution CT score

    Time: 8 weeks
    5 STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

    Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.

    NCT04409275
    Conditions
    1. Pulmonary Fibrosis
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2

    Measure: Pulmonary fibrotic changes, short and medium term

    Time: 12 months

    Description: To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.

    Measure: Degree of lung function impairment

    Time: 6 and 12 months

    Description: Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.

    Measure: Biological markers

    Time: 1 month
    6 Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection

    COVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.The most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms. Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both. Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.

    NCT04416100
    Conditions
    1. Covid-19
    2. Pulmonary Fibrosis
    Interventions
    1. Diagnostic Test: Pulmonary function tests
    2. Diagnostic Test: Imaging
    3. Biological: Blood sampling
    MeSH:Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial
    HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pulmonary fibrosis

    Primary Outcomes

    Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 1 month after discharge or diagnosis of COVID-19 disease by the use of HR-CT.

    Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month

    Time: 1 month

    Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 3 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT

    Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months

    Time: 3 months

    Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 6 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT

    Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months

    Time: 6 months
    7 A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients

    Randomized, double-blinded, placebo-controlled, two-arm study to evaluate the effectiveness and safety of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in 2019 Coronavirus Disease (COVID-19) patients recently discharged from the hospital. Patients will be randomized 1:1 to receive BIO 300 or placebo. All patients will receive the same background current standard of care.

    NCT04482595
    Conditions
    1. Pulmonary Fibrosis
    Interventions
    1. Drug: BIO 300 Oral Suspension
    2. Drug: Placebo
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)

    Measure: Change in DLCO

    Time: 12 Weeks

    Description: 6 minute walk test (6MWT)

    Measure: Change in 6 Minute Walk Test

    Time: 12 Weeks

    Secondary Outcomes

    Description: Forced vital capacity (FVC)

    Measure: Change in FVC

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.

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

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis

    Measure: Change in Pulmonary Fibrosis on HRCT Scan

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Incidence of hospitalization after initial discharge and initiating treatment

    Measure: Incidence of Re-Hospitalization

    Time: 12 Months

    Description: Mortality at 12 months after initiating treatment

    Measure: All-Cause Mortality

    Time: 12 Months

    Description: Forced expiratory volume in one second (FEV1)

    Measure: Change in FEV1

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)

    Measure: Change in FEV1/FVC Ratio

    Time: 12 Weeks, 6 Months and 12 Months

    Description: 6 minute walk test (6MWT)

    Measure: Change in 6 Minute Walk Test

    Time: 6 Months and 12 Months

    Description: Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)

    Measure: Change in Pulse Oximetry at Rest and During the 6MWT

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)

    Measure: Change in DLCO

    Time: 6 Months and 12 Months

    Description: Evaluate the safety of BIO 300 Oral Suspension treatment

    Measure: Adverse Events Related to BIO 300 Oral Suspension

    Time: 12 Months

    Description: Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)

    Measure: Change in Clinical Laboratory Values

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months

    Description: Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)

    Measure: Change in Clinical Laboratory Values

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months

    Description: Monitoring of blood serum levels for albumin (g/dL)

    Measure: Change in Clinical Laboratory Values for Albumin

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months

    Description: Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)

    Measure: Change in Clinical Laboratory Values for Serum Enzymes

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months

    Description: Monitoring of white blood cell, red blood cell and platelet counts

    Measure: Change in Complete Blood Counts with Differential

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months

    Other Outcomes

    Description: Prescribed supplemental oxygen flow rate at night, rest and exertion

    Measure: Change in Supplemental Oxygen Use

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Duration of supplemental oxygen use

    Measure: Change in Duration of Supplemental Oxygen Use

    Time: 12 Weeks, 6 Months and 12 Months

    Description: Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)

    Measure: Change in Serum Cytokine Expression

    Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
    8 Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands

    To date, little is known about the short and long-term complications of COVID-19. In order to obtain more insights in disease course and recovery of COVID-19 and to improve care after hospital admission, patients with COVID-19 will be monitored at home using an online home monitoring program for a period of 1 year.

    NCT04488562
    Conditions
    1. COVID-19
    2. Pulmonary Fibrosis
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

    Measure: VAS

    Time: 3 months

    Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

    Measure: VAS

    Time: 6 months

    Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

    Measure: VAS

    Time: 12 months

    Description: Body temperature measured with an thermometer

    Measure: Temperature

    Time: 3 months

    Description: Oxygen saturation measured with an pulse oximeter

    Measure: Oxygen measurements

    Time: 3 months

    Description: Oxygen saturation measured with an pulse oximeter

    Measure: Oxygen measurements

    Time: 6 months

    Description: Oxygen saturation measured with an pulse oximeter

    Measure: Oxygen measurements

    Time: 12 months

    Description: FVC change measured with home spirometry at 3 months (in %)

    Measure: Forced Vital Capacity (FVC) home spirometry in %

    Time: 3 months

    Description: FVC change measured with home spirometry at 3 months (in L)

    Measure: Forced Vital Capacity (FVC) home spirometry in L

    Time: 3 months

    Description: FVC change measured with home spirometry at 6 months (in %)

    Measure: Forced Vital Capacity (FVC) home spirometry in %

    Time: 6 months

    Description: FVC change measured with home spirometry at 6 months (in L)

    Measure: Forced Vital Capacity (FVC) home spirometry in L

    Time: 6 months

    Description: FVC change measured with home spirometry at 12 months (in L)

    Measure: Forced Vital Capacity (FVC) home spirometry in L

    Time: 12 months

    Description: FVC change measured with home spirometry at 12 months (in %)

    Measure: Forced Vital Capacity (FVC) home spirometry in %

    Time: 12 months

    Description: FVC change measured with hospital spirometry and saturation at 3 months (in %)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in %

    Time: 3 months

    Description: FVC change measured with hospital spirometry and saturation at 3 months (in L)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in L

    Time: 3 months

    Description: FVC change measured with hospital spirometry and saturation at 6 months (in %)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in %

    Time: 6 months

    Description: FVC change measured with hospital spirometry and saturation at 6 months (in L)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in L

    Time: 6 months

    Description: FVC change measured with hospital spirometry and saturation at 12 months (in %)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in %

    Time: 12 months

    Description: FVC change measured with hospital spirometry and saturation at 12 months (in L)

    Measure: Forced Vital Capacity (FVC) hospital spirometry in L

    Time: 12 months

    Description: The percentage of patients completed weekly home spirometry

    Measure: Adherence to weekly home spirometry

    Time: 1 year after inclusion

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: Baseline

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: 6 weeks

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: 3 months

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: 6 months

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: 9 months

    Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

    Measure: EQ5D

    Time: 12 months

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: Baseline

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: 6 weeks

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: 3 months weeks

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: 6 months weeks

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: 9 months weeks

    Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

    Measure: FAS

    Time: 12 months weeks

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: Baseline

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: 6 weeks

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: 3 months

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: 6 months

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: 9 months

    Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

    Measure: GRoC

    Time: 12 months

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: Baseline

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: 6 weeks

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: 3 months

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: 6 months

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: 9 months

    Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

    Measure: ABC tool

    Time: 12 months

    Secondary Outcomes

    Description: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time: 3 months

    Description: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time: 6 months

    Description: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time: 12 months

    Description: Predictors for the course of recovery of COVID-19 infection after hospital admission

    Measure: Predictors for the course of recovery of COVID-19 infection after hospital admission

    Time: 12 months

    Description: Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.

    Measure: Satisfaction of patients and caregivers with the use of a home monitoring system

    Time: 12 months
    9 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
    10 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
    11 "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
    12 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
    13 Phase-II Randomized Clinical Trial to Evaluate the Effect of Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis

    Study population: Patients with fibrotic lung sequelae after recovery from acute phase of severe COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administered for 24 weeks in patients who have pulmonary fibrotic changes after suffering severe COVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung

    NCT04607928
    Conditions
    1. Fibrotic Pulmonary Sequelae Post-COVID19 Infection
    Interventions
    1. Drug: Pirfenidone
    2. Drug: Placebo
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: To investigate the effect of pirfenidone administered for 24 weeks measuring the number of patients who have pulmonary fibrotic changes from baseline after suffering severe COVID19 pneumonia, analysed by Change From Baseline in % in forced vital capacity (FVC) Change From Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung

    Measure: To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection

    Time: 24 weeks

    Secondary Outcomes

    Description: Number of patients who show maintenance of stability or functional improvement: stability will be considered when the FVC does not increase more than 10% or does not decrease more than 10% and the DLCO does not increase more than 15% or decreases more than 15%. An increase in% FVC greater than 10% or in DLCO greater than 15% will be considered significant improvement.

    Measure: Maintenance of stability or functional improvement FVC

    Time: 24 weeks

    Description: Rate of decreased oxygen requirement for physical activity in patients

    Measure: Decreased oxygen requirement for physical activity

    Time: 24 weeks

    Description: Number of patients who have improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m

    Measure: Improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m

    Time: 24 weeks

    Description: Number of Hospitalizations (general and due to respiratory problems)

    Measure: Hospitalizations (general and due to respiratory problems)

    Time: 24 weeks

    Description: Number of Visits to the Emergency or Day Hospital for respiratory causes

    Measure: Visits to the Emergency or Day Hospital for respiratory causes

    Time: 24 weeks

    Description: Number of patients who need Lung transplantation

    Measure: Lung transplantation

    Time: 24 weeks

    Description: Number of patients who die

    Measure: Death

    Time: 24 weeks
    14 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
    15 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

    HPO Nodes


    Reports

    Data processed on December 13, 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  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

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    Alphabetical index of all Terms

    Google Colab

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