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D054990: Idiopathic 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 (15)


Name (Synonyms) Correlation
drug1223 D-dimer,CBC.ESR,CRP, Wiki 0.45
drug1637 Facial mask Wiki 0.45
drug494 BI 1015550 Wiki 0.45
Name (Synonyms) Correlation
drug1613 FFP2 Wiki 0.45
drug4804 [18F]FP-R01-MG-F2 Wiki 0.45
drug941 Centricyte 1000 Wiki 0.45
drug2460 MFS Wiki 0.45
drug2906 ORIN1001 Wiki 0.45
drug2357 Liver function tests ,serum ferritin and PCR for COVID-19 . Wiki 0.45
drug2050 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.45
drug2333 Liberase Enzyme (Roche) Wiki 0.45
drug4156 Sterile Normal Saline for Intravenous Use Wiki 0.45
drug2611 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.45
drug4259 TD-1058 Wiki 0.45
drug3195 Placebo Wiki 0.05

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D011658 Pulmonary Fibrosis NIH 0.53
D011649 Pulmonary Alveolar Proteinosis NIH 0.45
D015209 Cholangitis, Sclerosing NIH 0.45
Name (Synonyms) Correlation
D005355 Fibrosis NIH 0.38
D002761 Cholangitis NIH 0.32
D017563 Lung Diseases, Interstitial NIH 0.12
D008171 Lung Diseases, NIH 0.08
D011024 Pneumonia, Viral NIH 0.05
D003141 Communicable Diseases NIH 0.03
D011014 Pneumonia NIH 0.02
D007239 Infection NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0002206 Pulmonary fibrosis HPO 0.53
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.45
HP:0030151 Cholangitis HPO 0.32
Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 0.12
HP:0002088 Abnormal lung morphology HPO 0.08
HP:0002090 Pneumonia HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 5 clinical trials


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

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

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

Primary Outcomes

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

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

Time: an estimated average of 2 hours

Secondary Outcomes

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

Measure: Time Activity Measurements

Time: an estimated average of 1 hours

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

Measure: Incidence of Study Completion (Safety and Tolerability)

Time: an estimated average of 2 hours
2 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
3 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
4 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
5 Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib). A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days. The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.

NCT04643769
Conditions
  1. Idiopathic Pulmonary Fibrosis
Interventions
  1. Drug: ORIN1001
  2. Drug: Placebo
MeSH:Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

Description: measurement of blood pressure

Measure: Blood pressure

Time: Up to 60 days

Description: measurement of heart rate

Measure: Heart Rate

Time: Up to 60 days

Description: Measurement of respiratory rate

Measure: Respiratory Rate

Time: Up to 60 days

Description: Measurement of body temperature

Measure: Body Temperature

Time: Up to 60 days

Description: Cardiovascular evaluation to determine intervals including QTc interval

Measure: 12-lead ECG

Time: Up to 60 days

Description: ALT, albumin, ALP, AST, BUN, Ca, Cl, Cholesterol, Creatinine, CK, CA, Elastase, GGT, glucose, HDL, LDH, lipase, LDL, phosphorus, sodium, Total bilirubin, Total protein, Triglycerides, Uric acid, Lipid panel

Measure: Serum Clinical Chemistry analysis

Time: Up to 60 days

Description: WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT

Measure: Whole blood Hematology analysis

Time: Up to 60 dys

Description: PT, APTT, INR

Measure: Whole blood Coagulation Parameters

Time: Up to 60 days

Description: Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen

Measure: Urinalysis

Time: Up to 60 days

Description: Evaluation of other medications taken currently with investigative drug

Measure: Concomitant medications

Time: Up to 60 days

Description: Medical Health examination, medical history, medicine history, reproductive history, baseline information

Measure: Physical examination

Time: Up to 60 days

Description: Body weight in kg

Measure: Body weight

Time: Up to 60 days

Description: Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)

Measure: Spirometry

Time: Up to 60 days

Description: Height in cm

Measure: Height

Time: Up to 60 days

Description: Calculation of BMI using weight (kg) and height (cm)

Measure: Body mass index (BMI)

Time: Up to 60 days

Description: Lung test to assess diffusion capacity

Measure: DLCO - Assessment of diffusion capacity

Time: Up to 60 days

Secondary Outcomes

Description: Blood collection for evaluation of ORIN1001 exposure. Measurements will assess half life, exposure, maximum concentration, time to maximum concentration and accumulation ratios

Measure: Blood collection to measure drug concentration over time

Time: Up to 29 days

Other Outcomes

Description: Blood collection for evaluation of disease biomarker of lung fibrosis: SP-D, MMP-7 and KL6. Specific biomarker to be determined

Measure: Exploratory biomarkers to evaluate lung fibrosis

Time: Up to 60 days

Description: Questionnaire to assess the quality of life during the study period

Measure: Quality of Life Questionnaire

Time: Up to 60 days

Description: Blood collection for evaluation of inflammation such as cytokines TGF-B and/or IL-6

Measure: Exploratory biomarkers to evaluate inflammation

Time: Up to 60 days

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


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

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