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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 (24)


    Name (Synonyms) Correlation
    drug3152 Pulmonary function tests Wiki 0.26
    drug4703 respiratory function rehabilitation training Wiki 0.26
    drug2370 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.26
    Name (Synonyms) Correlation
    drug4250 Vitamin C tablets Wiki 0.26
    drug1871 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.26
    drug3781 Sterile Normal Saline for Intravenous Use Wiki 0.26
    drug871 Centricyte 1000 Wiki 0.26
    drug2551 Nintedanib 150 MG [Ofev] Wiki 0.26
    drug1586 Fuzheng Huayu Tablet Wiki 0.26
    drug2127 Liberase Enzyme (Roche) Wiki 0.26
    drug1891 Imaging Wiki 0.26
    drug2549 Nintedanib Wiki 0.26
    drug461 BI 1015550 Wiki 0.26
    drug3875 TD-1058 Wiki 0.26
    drug1858 IN01 vaccine Wiki 0.26
    drug474 BIO 300 Oral Suspension Wiki 0.26
    drug4440 control Wiki 0.26
    drug2550 Nintedanib 150 MG Wiki 0.26
    drug974 Collagen-Polyvinylpyrrolidone Wiki 0.26
    drug2915 Pirfenidone Wiki 0.26
    drug42 20 Mg Prednisone for 14 days Wiki 0.26
    drug1459 Exposure Wiki 0.18
    drug614 Blood sampling Wiki 0.11
    drug2916 Placebo Wiki 0.09

    Correlated MeSH Terms (13)


    Name (Synonyms) Correlation
    D011658 Pulmonary Fibrosis NIH 1.00
    D005355 Fibrosis NIH 0.49
    D054990 Idiopathic Pulmonary Fibrosis NIH 0.45
    Name (Synonyms) Correlation
    D011649 Pulmonary Alveolar Proteinosis NIH 0.26
    D017563 Lung Diseases, Interstitial NIH 0.21
    D008171 Lung Diseases, NIH 0.16
    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
    D007239 Infection NIH 0.01
    D045169 Severe Acute Respiratory Syndrome NIH 0.01
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (3)


    Name (Synonyms) Correlation
    HP:0006517 Intraalveolar phospholipid accumulation HPO 0.26
    HP:0006515 Interstitial pneumonitis HPO 0.21
    HP:0002088 Abnormal lung morphology HPO 0.16

    Clinical Trials

    Navigate: Correlations   HPO

    There are 15 clinical trials


    1 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
    2 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 Interstitial pneumonitis Interstitial pulmonary abnormality 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
    3 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
    4 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
    5 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 Interstitial pneumonitis Interstitial pulmonary abnormality 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
    6 A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally

    To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC). To investigate safety and tolerability of BI 1015550 in the overall trial population.

    NCT04419506
    Conditions
    1. Idiopathic Pulmonary Fibrosis
    Interventions
    1. Drug: BI 1015550
    2. Drug: Placebo
    MeSH:Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Measure: change from baseline in Forced Vital Capacity (FVC)

    Time: up to 12 weeks

    Secondary Outcomes

    Measure: percentage of patients with Treatment Emergent Adverse Events (TEAE)

    Time: up to 13 weeks
    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: Diffusing capacity of the lungs for carbon monoxide (DLCO)

    Measure: Change in DLCO

    Time: 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: Forced vital capacity (FVC)

    Measure: Change in FVC

    Time: 12 Weeks, 6 Months and 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: 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: Evidence of pulmonary fibrosis on computerized tomography (CT) 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 CT Scan

    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: 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 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 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

    Description: Mortality at 12 months after initiating treatment

    Measure: All-Cause Mortality

    Time: 12 Months

    Description: Incidence of hospitalization after initial discharge and initiating treatment

    Measure: Incidence of Re-Hospitalization

    Time: 12 Months

    Description: Evaluate the safety of BIO 300 Oral Suspension treatment

    Measure: Adverse Events Related to BIO 300 Oral Suspension

    Time: 12 Months

    Other Outcomes

    Description: Duration of supplemental oxygen use

    Measure: Change in Duration of Supplemental Oxygen Use

    Time: 12 Weeks, 6 Months and 12 Months

    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: 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 A Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 3-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C)

    This is a Phase 1, 3-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution. Part A is a SAD study in healthy subjects, Part B is a MAD study in healthy subjects, and Part C is a multiple-dose study in subjects with IPF.

    NCT04589260
    Conditions
    1. Idiopathic Pulmonary Fibrosis (IPF)
    Interventions
    1. Drug: TD-1058
    2. Drug: Placebo
    MeSH:Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Number and severity of treatment emergent adverse events

    Measure: Part A (SAD) - Adverse Events

    Time: Part A (SAD) Day 1 to Day 8

    Description: Number and severity of treatment emergent adverse events

    Measure: Part B (MAD) - Adverse Events

    Time: Part B (MAD) Day 1 to Day 21

    Description: Number and severity of treatment emergent adverse events

    Measure: Part C (IPF) - Adverse Events

    Time: Part C (IPF) Day 1 to Day 35

    Secondary Outcomes

    Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

    Measure: Pharmacokinetics (PK) of TD-1058: AUC

    Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35

    Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Maximum observed concentration (Cmax)

    Measure: Pharmacokinetics (PK) of TD-1058: Cmax

    Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35

    Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

    Measure: Pharmacokinetics (PK) of TD-1058: Tmax

    Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35
    14 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
    15 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 Interstitial pneumonitis Interstitial pulmonary abnormality 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

    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,180 reports on interventions/drugs

    MeSH

    691 reports on MeSH terms

    HPO

    263 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook