Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1223 | D-dimer,CBC.ESR,CRP, Wiki | 0.24 |
| drug1637 | Facial mask Wiki | 0.24 |
| drug1054 | Collagen-Polyvinylpyrrolidone Wiki | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1724 | Fuzheng Huayu Tablet Wiki | 0.24 |
| drug2037 | IN01 vaccine Wiki | 0.24 |
| drug4867 | bovhyaluronidase azoxymer Wiki | 0.24 |
| drug2802 | Nintedanib 150 MG Wiki | 0.24 |
| drug494 | BI 1015550 Wiki | 0.24 |
| drug1613 | FFP2 Wiki | 0.24 |
| drug4804 | [18F]FP-R01-MG-F2 Wiki | 0.24 |
| drug941 | Centricyte 1000 Wiki | 0.24 |
| drug2801 | Nintedanib Wiki | 0.24 |
| drug2460 | MFS Wiki | 0.24 |
| drug2906 | ORIN1001 Wiki | 0.24 |
| drug2357 | Liver function tests ,serum ferritin and PCR for COVID-19 . Wiki | 0.24 |
| drug2050 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.24 |
| drug2333 | Liberase Enzyme (Roche) Wiki | 0.24 |
| drug2072 | Imaging Wiki | 0.24 |
| drug2803 | Nintedanib 150 MG [Ofev] Wiki | 0.24 |
| drug4156 | Sterile Normal Saline for Intravenous Use Wiki | 0.24 |
| drug4901 | control Wiki | 0.24 |
| drug2611 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.24 |
| drug3452 | Pulmonary function tests Wiki | 0.24 |
| drug512 | BIO 300 Oral Suspension Wiki | 0.24 |
| drug44 | 20 Mg Prednisone for 14 days Wiki | 0.24 |
| drug4259 | TD-1058 Wiki | 0.24 |
| drug5187 | respiratory function rehabilitation training Wiki | 0.24 |
| drug4691 | Vitamin C tablets Wiki | 0.24 |
| drug3193 | Pirfenidone Wiki | 0.17 |
| drug3195 | Placebo Wiki | 0.09 |
| drug663 | Blood sampling Wiki | 0.08 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011658 | Pulmonary Fibrosis NIH | 1.00 |
| D005355 | Fibrosis NIH | 0.55 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.53 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D017563 | Lung Diseases, Interstitial NIH | 0.24 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.24 |
| D015209 | Cholangitis, Sclerosing NIH | 0.24 |
| D002761 | Cholangitis NIH | 0.17 |
| D008171 | Lung Diseases, NIH | 0.16 |
| D012120 | Respiration Disorders NIH | 0.05 |
| D012140 | Respiratory Tract Diseases NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D011014 | Pneumonia NIH | 0.01 |
| D007239 | Infection NIH | 0.01 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006515 | Interstitial pneumonitis HPO | 0.24 |
| HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.24 |
| HP:0030151 | Cholangitis HPO | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002088 | Abnormal lung morphology HPO | 0.16 |
| HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 18 clinical trials
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT
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 hoursDescription: 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 hoursDescription: 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 hoursAccording 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.
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 24Description: Evaluation of Lung Function Improvement
Measure: Blood oxygen saturation Time: Week 24Description: 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 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Quality of Life-BREF (QOL-BREF) Time: Week 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Patient Health Questionnaire-9(PHQ-9) Time: Week 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Generalized anxiety disorder-7(GAD-7) Time: Week 24Description: Evaluation of Lung Function Improvement
Measure: The 6-minute walk distance Time: Week 24COVID-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.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: 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 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsThis 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.
Description: Changes in forced vital capacity (FVC) after treatment compared to baseline.
Measure: Changes in forced vital capacity (FVC) Time: 8 weeksDescription: Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.
Measure: Changes in carbon monoxide dispersion (DLco%) Time: 8 weeksDescription: Changes in the six-minute walk test (6MWT) after treatment compared to baseline.
Measure: Changes in the six-minute walk test (6MWT) Time: 8 weeksDescription: 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 weeksProspective, 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.
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 monthsDescription: 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 monthsDescription: 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 monthCOVID-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.
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 monthDescription: 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 monthsDescription: 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 monthsTo 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.
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.
Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 12 WeeksDescription: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 12 WeeksDescription: Forced vital capacity (FVC)
Measure: Change in FVC Time: 12 Weeks, 6 Months and 12 MonthsDescription: 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 MonthsDescription: Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
Measure: Change in Pulmonary Fibrosis on HRCT Scan Time: 12 Weeks, 6 Months and 12 MonthsDescription: Incidence of hospitalization after initial discharge and initiating treatment
Measure: Incidence of Re-Hospitalization Time: 12 MonthsDescription: Mortality at 12 months after initiating treatment
Measure: All-Cause Mortality Time: 12 MonthsDescription: Forced expiratory volume in one second (FEV1)
Measure: Change in FEV1 Time: 12 Weeks, 6 Months and 12 MonthsDescription: 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 MonthsDescription: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 6 Months and 12 MonthsDescription: 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 MonthsDescription: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 6 Months and 12 MonthsDescription: Evaluate the safety of BIO 300 Oral Suspension treatment
Measure: Adverse Events Related to BIO 300 Oral Suspension Time: 12 MonthsDescription: 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 MonthsDescription: 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 MonthsDescription: 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 MonthsDescription: 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 MonthsDescription: 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 MonthsDescription: Prescribed supplemental oxygen flow rate at night, rest and exertion
Measure: Change in Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 MonthsDescription: Duration of supplemental oxygen use
Measure: Change in Duration of Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 MonthsDescription: 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 MonthsTo 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Body temperature measured with an thermometer
Measure: Temperature Time: 3 monthsDescription: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 3 monthsDescription: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 6 monthsDescription: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 12 monthsDescription: FVC change measured with home spirometry at 3 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 3 monthsDescription: FVC change measured with home spirometry at 3 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 3 monthsDescription: FVC change measured with home spirometry at 6 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 6 monthsDescription: FVC change measured with home spirometry at 6 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 6 monthsDescription: FVC change measured with home spirometry at 12 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 12 monthsDescription: FVC change measured with home spirometry at 12 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 12 monthsDescription: FVC change measured with hospital spirometry and saturation at 3 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 3 monthsDescription: FVC change measured with hospital spirometry and saturation at 3 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 3 monthsDescription: FVC change measured with hospital spirometry and saturation at 6 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 6 monthsDescription: FVC change measured with hospital spirometry and saturation at 6 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 6 monthsDescription: FVC change measured with hospital spirometry and saturation at 12 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 12 monthsDescription: FVC change measured with hospital spirometry and saturation at 12 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 12 monthsDescription: The percentage of patients completed weekly home spirometry
Measure: Adherence to weekly home spirometry Time: 1 year after inclusionDescription: 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: BaselineDescription: 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 weeksDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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: BaselineDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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: BaselineDescription: 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 weeksDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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: BaselineDescription: 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 weeksDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 3 monthsDescription: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 6 monthsDescription: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 12 monthsDescription: 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 monthsDescription: 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 monthsSARS-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.
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 daysDescription: 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 monthsMethodology: 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.
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 yearDescription: 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 52Description: 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 52Description: 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 52Currently, 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.
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.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 monthsDescription: Absolute change from baseline in the Six-minute walk test (6MWT) at 12 months
Measure: compare exercise capacity at 12 months Time: at 12 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: MUC5B at risk allele detection at inclusion
Measure: association between genetic susceptibility (MUC5B polymorphism) and lung fibrosis in COVID-19 survivors Time: at inclusionDescription: Incidence of clinical or biological adverse events with nintedanib versus placebo over 12 months
Measure: safety of nintedanib Time: over 12 monthsA randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
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 daysThis 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.
Description: Number and severity of treatment emergent adverse events
Measure: Part A (SAD) - Adverse Events Time: Part A (SAD) Day 1 to Day 8Description: Number and severity of treatment emergent adverse events
Measure: Part B (MAD) - Adverse Events Time: Part B (MAD) Day 1 to Day 21Description: Number and severity of treatment emergent adverse events
Measure: Part C (IPF) - Adverse Events Time: Part C (IPF) Day 1 to Day 35Description: 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 35Description: 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 35Description: 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 35Study 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
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 weeksDescription: 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 weeksDescription: Rate of decreased oxygen requirement for physical activity in patients
Measure: Decreased oxygen requirement for physical activity Time: 24 weeksDescription: 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 weeksDescription: Number of Hospitalizations (general and due to respiratory problems)
Measure: Hospitalizations (general and due to respiratory problems) Time: 24 weeksDescription: 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 weeksDescription: Number of patients who need Lung transplantation
Measure: Lung transplantation Time: 24 weeksDescription: Number of patients who die
Measure: Death Time: 24 weeksThis 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.
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 daysDescription: 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 daysDescription: 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 daysDescription: 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 90Description: 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 180Description: 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 90Description: 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 180Description: 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 90Description: 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 180Description: 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 90Description: 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 180Description: 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 90Description: 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 180Description: 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 90Description: 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 180Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 90Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 180Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 90Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 180Description: 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 90Description: 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 180This 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.
Description: measurement of blood pressure
Measure: Blood pressure Time: Up to 60 daysDescription: measurement of heart rate
Measure: Heart Rate Time: Up to 60 daysDescription: Measurement of respiratory rate
Measure: Respiratory Rate Time: Up to 60 daysDescription: Measurement of body temperature
Measure: Body Temperature Time: Up to 60 daysDescription: Cardiovascular evaluation to determine intervals including QTc interval
Measure: 12-lead ECG Time: Up to 60 daysDescription: 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 daysDescription: WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT
Measure: Whole blood Hematology analysis Time: Up to 60 dysDescription: PT, APTT, INR
Measure: Whole blood Coagulation Parameters Time: Up to 60 daysDescription: Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen
Measure: Urinalysis Time: Up to 60 daysDescription: Evaluation of other medications taken currently with investigative drug
Measure: Concomitant medications Time: Up to 60 daysDescription: Medical Health examination, medical history, medicine history, reproductive history, baseline information
Measure: Physical examination Time: Up to 60 daysDescription: Body weight in kg
Measure: Body weight Time: Up to 60 daysDescription: Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)
Measure: Spirometry Time: Up to 60 daysDescription: Height in cm
Measure: Height Time: Up to 60 daysDescription: Calculation of BMI using weight (kg) and height (cm)
Measure: Body mass index (BMI) Time: Up to 60 daysDescription: Lung test to assess diffusion capacity
Measure: DLCO - Assessment of diffusion capacity Time: Up to 60 daysDescription: 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 daysDescription: 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 daysDescription: Questionnaire to assess the quality of life during the study period
Measure: Quality of Life Questionnaire Time: Up to 60 daysDescription: 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 daysA 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.
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 75Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Description: 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 75Description: 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 75Description: 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 75Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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