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D017563: Lung Diseases, Interstitial

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 (32)


Name (Synonyms) Correlation
drug1637 Facial mask Wiki 0.26
drug4867 bovhyaluronidase azoxymer Wiki 0.26
drug4139 Standard treatment according to the Clinical protocols Wiki 0.26
Name (Synonyms) Correlation
drug1613 FFP2 Wiki 0.26
drug941 Centricyte 1000 Wiki 0.26
drug2801 Nintedanib Wiki 0.26
drug2460 MFS Wiki 0.26
drug1009 Clinical, laboratory and imaging characteristics of pneumonia Wiki 0.26
drug2050 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.26
drug1412 EHR-based Clinician Jumpstart Wiki 0.26
drug2333 Liberase Enzyme (Roche) Wiki 0.26
drug3886 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.26
drug3810 SELF-BREATHE Wiki 0.26
drug2072 Imaging Wiki 0.26
drug988 Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument Wiki 0.26
drug4156 Sterile Normal Saline for Intravenous Use Wiki 0.26
drug2611 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.26
drug3452 Pulmonary function tests Wiki 0.26
drug4969 high-titer anti-Sars-CoV-2 plasma Wiki 0.26
drug3454 Pulmonary ultrasound Wiki 0.26
drug276 Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Wiki 0.26
drug4440 Tofacitinib Wiki 0.18
drug3218 Placebo Comparator Wiki 0.18
drug541 Bacille Calmette-Guérin (BCG) Wiki 0.18
drug5117 oxygen therapy Wiki 0.18
drug1238 DWRX2003 Wiki 0.15
drug502 BI 764198 Wiki 0.15
drug2528 Matching placebo Wiki 0.13
drug895 Camostat Wiki 0.12
drug663 Blood sampling Wiki 0.09
drug1950 Hydroxychloroquine Wiki 0.03
drug3195 Placebo Wiki 0.02

Correlated MeSH Terms (36)


Name (Synonyms) Correlation
D008171 Lung Diseases, NIH 0.36
D000542 Alveolitis, Extrinsic Allergic NIH 0.26
D011649 Pulmonary Alveolar Proteinosis NIH 0.26
Name (Synonyms) Correlation
D001469 Barotrauma NIH 0.26
D017093 Liver Failure NIH 0.26
D011658 Pulmonary Fibrosis NIH 0.24
D001987 Bronchiectasis NIH 0.21
D004646 Emphysema NIH 0.18
D016491 Peripheral Vascular Diseases NIH 0.15
D000755 Anemia, Sickle Cell NIH 0.13
D008103 Liver Cirrhosis, NIH 0.13
D058729 Peripheral Arterial Disease NIH 0.13
D014652 Vascular Diseases NIH 0.13
D011014 Pneumonia NIH 0.12
D006967 Hypersensitivity, NIH 0.12
D054990 Idiopathic Pulmonary Fibrosis NIH 0.12
D011024 Pneumonia, Viral NIH 0.11
D005355 Fibrosis NIH 0.11
D007676 Kidney Failure, Chronic NIH 0.11
D009362 Neoplasm Metastasis NIH 0.10
D003550 Cystic Fibrosis NIH 0.09
D053717 Pneumonia, Ventilator-Associated NIH 0.09
D051437 Renal Insufficiency, NIH 0.09
D004417 Dyspnea NIH 0.08
D002908 Chronic Disease NIH 0.07
D008175 Lung Neoplasms NIH 0.06
D006333 Heart Failure NIH 0.06
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.06
D012120 Respiration Disorders NIH 0.05
D007251 Influenza, Human NIH 0.05
D012140 Respiratory Tract Diseases NIH 0.05
D009369 Neoplasms, NIH 0.04
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 (17)


Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 1.00
HP:0002088 Abnormal lung morphology HPO 0.36
HP:0006516 Hypersensitivity pneumonitis HPO 0.26
Name (Synonyms) Correlation
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.26
HP:0001399 Hepatic failure HPO 0.26
HP:0002206 Pulmonary fibrosis HPO 0.24
HP:0002110 Bronchiectasis HPO 0.21
HP:0001395 Hepatic fibrosis HPO 0.13
HP:0002090 Pneumonia HPO 0.12
HP:0012393 Allergy HPO 0.12
HP:0004950 Peripheral arterial stenosis HPO 0.10
HP:0000083 Renal insufficiency HPO 0.09
HP:0002098 Respiratory distress HPO 0.08
HP:0100526 Neoplasm of the lung HPO 0.06
HP:0001635 Congestive heart failure HPO 0.06
HP:0006510 Chronic pulmonary obstruction HPO 0.06
HP:0002664 Neoplasm HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 15 clinical trials


1 Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

The objective of this study is to administer and validate a disease specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP).

NCT04273867
Conditions
  1. Hypersensitivity Pneumonitis
  2. Chronic Hypersensitivity Pneumonitis
  3. Interstitial Lung Disease
  4. Extrinsic Allergic Alveolitis
  5. Health-related Quality of Life
Interventions
  1. Other: Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument
MeSH:Lung Diseases Lung Diseases, Interstitial Pneumonia Alveolitis, Extrinsic Allergic Hypersensitivity
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Allergy Hypersensitivity pneumonitis Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: The newly developed survey that is being validated consists of 42 items that assess the impact that Hypersensitivity Pneumonitis has on daily life for those who have the disease.

Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis

Time: Day 0

Description: This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 12 items. The average score for this survey has been calibrated to 50 with scores below 50 indicating a below average score and scores above 50 indicating an above average score.

Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey

Time: Day 0

Description: This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 15 items and is scored from 0-100 with 100 indicating good health.

Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the King's Brief Interstitial Lung Disease Questionnaire

Time: Day 0

Description: The newly developed survey will be administered again in 2 weeks following the first assessment.

Measure: Change in Health-related Quality of Life Assessment Score

Time: 2 weeks following Day 0
2 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

NCT04281784
Conditions
  1. Dementia
  2. Chronic Disease
  3. Neoplasm Metastasis
  4. Lung Neoplasm
  5. Pulmonary Disease, Chronic Obstructive
  6. Heart Failure,Congestive
  7. Liver Cirrhosis
  8. Kidney Failure, Chronic
  9. Lung Diseases, Interstitial
  10. Peripheral Vascular Disease
  11. Diabetes With End Organ Injury
  12. Palliative Care, Patient Care
  13. Health Care Quality, Access, and Evaluation
  14. Patient Care
  15. Inpatients
  16. Health Communication
  17. Patient Care Planning
Interventions
  1. Behavioral: EHR-based Clinician Jumpstart
MeSH:Neoplasms Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease
HPO:Abnormal left ventricular function Abnormal lung morphology Abnormal pulmonary Interstitial morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

Primary Outcomes

Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

Measure: EHR documentation of Goals of Care discussions

Time: Assessed for the period between randomization and 30 days following randomization

Secondary Outcomes

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU admissions

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/Hospital use: Hospital length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: Hospital Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: ICU Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

Measure: Intensity of care: Healthcare costs

Time: 1 and 3 months after randomization

Description: From Washington State death certificates.

Measure: All-cause mortality at 1 year (safety outcome)

Time: 1 year after randomization

Other Outcomes

Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

Measure: Key Implementation Factors

Time: 3 months after randomization
3 The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations

This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza

NCT04313946
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Influenza With Pneumonia
  4. Flu Symptom
  5. Flu Like Illness
  6. Pneumonia, Interstitial
  7. Pneumonia, Ventilator-Associated
  8. Pneumonia Atypical
Interventions
  1. Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive

Measure: COVID-19 positive X-Rays

Time: 6 months

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative

Measure: COVID-19 negative X-Rays

Time: 6 months
4 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
5 Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19

Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

NCT04333251
Conditions
  1. Pneumonia, Interstitial
Interventions
  1. Biological: high-titer anti-Sars-CoV-2 plasma
  2. Other: oxygen therapy
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: reduction in oxygen and ventilation support

Measure: reduction in oxygen and ventilation support

Time: through study completion, an average of 4 weeks
6 Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +

The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5]. The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1. The secondary objectives are: - Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations. - Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.

NCT04335019
Conditions
  1. 2019-nCoV (COVID-19)
  2. Interstitial Pneumonia
Interventions
  1. Other: Pulmonary ultrasound
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity There are few B lines at the lung bases Bi-lateralization of B lines, numerous diffuse and / or curtain sign Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)

Measure: Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity

Time: at day0

Secondary Outcomes

Measure: Assessment of the agreement between a newly trained operator and an experienced operator of classification in one of the three stages of ultrasound gravity, by Cohen's kappa coefficient.

Time: at day0

Measure: Estimate in patients who had a CT-scan on D0, the agreement in the evaluation of the severity of lung lesions via ultrasound vs. CT-scan, by Cohen's kappa coefficient

Time: at day0

Measure: Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival

Time: at day5

Measure: Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival

Time: at day15

Measure: Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival

Time: at day28
7 Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

NCT04382547
Conditions
  1. COVID
  2. Covid-19
  3. Coronavirus
  4. Pneumonia
  5. Pneumonia, Viral
  6. Pneumonia, Interstitial
  7. Sars-CoV2
Interventions
  1. Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
  2. Other: Standard treatment according to the Clinical protocols
MeSH:Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Number of patients cured, assessed by PCR in addition to chest CT scan

Measure: Number of cured patients

Time: 3 weeks

Secondary Outcomes

Description: MSC infusion related adverse events assessed by blood count, liver and function tests

Measure: Number of patients with treatment-related adverse events

Time: 3 weeks
8 TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With Early Onset SARS-CoV2 (COVID-19) Interstitial Pneumonia:a Multicenter Randomized Controlled Open Label Trial

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

NCT04390061
Conditions
  1. Pneumonitis, Interstitial
  2. COVID-19
Interventions
  1. Drug: Tofacitinib
  2. Drug: Hydroxychloroquine
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150

Measure: Prevention of severe Respiratory Failure requiring mechanical ventilation

Time: 14 days

Secondary Outcomes

Description: Rate of patients needing admission to the intensive care unit

Measure: Prevention of need of ICU admission

Time: 28 days

Description: Rate of patients who die due to COVID-19 related conditions

Measure: Prevention of COVID-19 related Deaths

Time: 28 days

Description: Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D )

Measure: Identification of predictors of outcome

Time: 14 days

Description: Rate of severe drug-related adverse events

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 28 days
9 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
10 SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia

Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.

NCT04435327
Conditions
  1. COVID
  2. Pneumonia, Viral
  3. Barotrauma
  4. Interstitial Lung Disease
  5. Bronchiectasis Adult
  6. Emphysema
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Bronchiectasis Lung Diseases, Interstitial Emphysema Barotrauma
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Bronchiectasis Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Reduction below 80% of predicted values of DLCO

Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)

Time: T1 at 6 months from discharge

Description: Reduction below 80% of predicted values of DLCO

Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)

Time: T2 at 12 months from discharge

Secondary Outcomes

Description: reduction in maximum distance walked

Measure: Alterations in 6 minute walking test (6MWT)

Time: T1 at 6 months from discharge

Description: reduction in maximum distance walked

Measure: Alterations in 6 minute walking test (6MWT)

Time: T2 at 12 months from discharge

Description: reduction in oxygen saturation nadir

Measure: Alterations in 6 minute walking test (6MWT)

Time: T1 at 6 months from discharge

Description: reduction in oxygen saturation nadir

Measure: Alterations in 6 minute walking test (6MWT)

Time: T2 at 12 months from discharge

Description: reduction of Forced Vital Capacity (FVC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Vital Capacity (FVC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Vital Capacity (FVC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Vital Capacity (FVC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Total Lung Capacity (TLC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Total Lung Capacity (TLC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Total Lung Capacity (TLC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Total Lung Capacity (TLC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV,%)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (absolute value)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (%)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (absolute value)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (%)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

Description: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)

Measure: Abnormal Dyspnea Score

Time: T1 at 6 months from discharge

Description: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)

Measure: Abnormal Dyspnea Score

Time: T2 at 12 months from discharge

Description: Presence and extension of abnormal pulmonary lung sounds at auscultation

Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation

Time: T1 at 6 months from discharge

Description: Presence and extension of abnormal pulmonary lung sounds at auscultation

Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation

Time: T2 at 12 months from discharge

Description: Presence and extension of radiological alterations at chest X-ray

Measure: Presence and extension of radiological alterations at chest X-ray

Time: T1 at 6 months from discharge

Description: Presence and extension of radiological alterations at chest CT scan

Measure: Presence and extension of radiological alterations at chest CT scan

Time: T2 at 12 months from discharge
11 Identification of Predictors for the Evolution of COVID-19 Related Interstitial Pneumonia by Transcriptomic and Seroproteomic Techniques

The investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from COVID-19 disease. In particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with COVID-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage. The study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. Genome analysis will allow the genotype to be correlated to the identified gene expression profiles.

NCT04441502
Conditions
  1. Covid19
  2. Interstitial Pneumonia
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Identify circulating transcripts (coding and non-coding for proteins) or cytokines and chemokines which, alone or in combination (COVID19_signature), are predictive of adverse events (death, endotracheal intubation) and the prognostic capacity of COVID19_signature in the prediction of adverse events in additional to the use of standard clinical parameters

Measure: Circulating markers for COVID-19 signature

Time: From ICU/ward admission for 8 weeks follow/up

Secondary Outcomes

Description: Evaluate the association of COVID19_signature with adverse cardiovascular events. Adverse cardiovascular events are defined: death from cardiovascular causes, acute coronary syndrome, troponin T levels greater than the ninety-ninth percentile of the upper reference limit, stroke, cardiac arrhythmias, development of heart failure, venous thromboembolism

Measure: COVID-19 signature and adverse cardiovascular events

Time: From ICU/ward admission for 8 weeks follow/up

Description: Evaluate, in a subset of 20 patients, the characteristics of the coagulation pattern with specific tests for thrombin generation and fibrinolysis.

Measure: COVID-19 related coagulation pattern

Time: From ICU/ward admission for 8 weeks follow/up
12 Clinical, Laboratory and Imaging Comparison Between COVID-19 Pneumonia Confirmed by PCR Detection on Nasopharyngeal Swab and Negative Swab Pneumonia

In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.

NCT04507893
Conditions
  1. Covid19
  2. Interstitial Pneumonia
Interventions
  1. Other: Clinical, laboratory and imaging characteristics of pneumonia
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Accuracy of severity of respiratory insufficiency - evaluated as need of three step "nasal oxygen, oxygen mask, invasive ventilation" - in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls"

Measure: Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days

Description: Accuracy of the association of 3 haemato-chemical abnormalities (lymphopenia + increased serum transaminases + increased serum LDH) in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".

Measure: Evaluation of the laboratory characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days

Description: Accuracy of thorax CT scan in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".

Measure: Evaluation of the imaging characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days

Secondary Outcomes

Description: Evaluation of mortality in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.

Measure: Evaluation of mortality of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days

Description: Evaluation of clinical severity in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.

Measure: Evaluation of clinical severity of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days

Description: Evaluation of hospital stay length in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.

Measure: Evaluation of hospital stay length of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

Time: 75 Days
13 A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial

A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)

NCT04574050
Conditions
  1. Cancer
  2. COPD
  3. Asthma
  4. Bronchiectasis Adult
  5. Interstitial Lung Disease
  6. Cystic Fibrosis
  7. Chronic Heart Failure
  8. Sickle Cell Disease
  9. Renal Failure
  10. Liver Failure
  11. Post COVID-19
  12. Dyspnea
Interventions
  1. Other: SELF-BREATHE
MeSH:Cystic Fibrosis Liver Failure Lung Diseases Dyspnea Bronchiectasis Lung Diseases, Interstitial Anemia, Sickle Cell
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Bronchiectasis Dyspnea Hepatic failure Interstitial pneumonitis Respiratory distress

Primary Outcomes

Description: The number of patients recruited into this study over a 12-month period

Measure: Feasibility: the number of patients recruited into this study over a 12-month period

Time: 12 months
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

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook