Covid 19 Research using Clinical Trials (Home Page)
HP:0002206: Pulmonary fibrosisHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (17)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2281 | Pulmonary function tests Wiki | 0.38 |
| drug1383 | Imaging Wiki | 0.38 |
| drug1365 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.38 |
| drug1569 | Liberase Enzyme (Roche) Wiki | 0.38 |
| drug631 | Centricyte 1000 Wiki | 0.38 |
| drug1868 | Nintedanib 150 MG Wiki | 0.38 |
| drug1805 | N-acetylcysteine+ Fuzheng Huayu Tablet Wiki | 0.38 |
| drug346 | BIO 300 Oral Suspension Wiki | 0.38 |
| drug1746 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.38 |
| drug2743 | Sterile Normal Saline for Intravenous Use Wiki | 0.38 |
| drug1806 | N-acetylcysteine+Placebo Wiki | 0.38 |
| drug1600 | Lopinavir/ Ritonavir Placebo Wiki | 0.38 |
| drug1598 | Lopinavir/ Ritonavir Wiki | 0.38 |
| drug1095 | Favipiravir Placebo Wiki | 0.27 |
| drug452 | Blood sampling Wiki | 0.22 |
| drug1087 | Favipiravir Wiki | 0.09 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011658 | Pulmonary Fibrosis NIH | 1.00 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.38 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.38 |
| D017563 | Lung Diseases, Interstitial NIH | 0.22 |
| D008171 | Lung Diseases, NIH | 0.18 |
| D005355 | Fibrosis NIH | 0.14 |
| D011024 | Pneumonia, Viral NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.03 |
| D007239 | Infection NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.01 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.38 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.22 |
| HP:0002088 | Abnormal lung morphology HPO | 0.18 |
There are 7 clinical trials
Clinical Trials
1 A Randomized, Placebo-Controlled, Multi-Center Study on the Efficacy and Safety of Fuzheng Huayu on Pulmonary Fibrosis Due to 2019-nCoV
Inflammation is the early stage of fibrosis. Serious patients are more likely to develop into pulmonary fibrosis, which affects the recurrence of lung function or even threatens life and health. This study is planned to observe the efficacy and safety of Fuzheng Huayu tablets in the treatment of pulmonary fibrosis after COVID-19.
NCT04279197 Pulmonary Fibrosis Due to 2019-nCoV Drug: N-acetylcysteine+ Fuzheng Huayu Tablet Drug: N-acetylcysteine+Placebo MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis
Primary Outcomes
Description: Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.
Measure: High-resolution computed tomography (HRCT) score Time: Week 24
Description: Evaluation of Lung Function Improvement
Measure: Lung function including FVC, FVC as a percentage of projected value and DLco Time: Week 24
Secondary Outcomes
Description: Times of acute exacerbations during treatment
Measure: Times of acute exacerbation Time: Week 24
Description: Measured by a 6-minute walking test
Measure: Six-minute walk distance Time: Week 24
Description: Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Measure: Dyspnea Scores Time: Week 24
Description: Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.
Measure: Composite physiological index Time: Week 24
2 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection
Primary Outcomes
Description: Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.
Measure: High-resolution computed tomography (HRCT) score Time: Week 24Description: Evaluation of Lung Function Improvement
Measure: Lung function including FVC, FVC as a percentage of projected value and DLco Time: Week 24Secondary Outcomes
Description: Times of acute exacerbations during treatment
Measure: Times of acute exacerbation Time: Week 24Description: Measured by a 6-minute walking test
Measure: Six-minute walk distance Time: Week 24Description: Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Measure: Dyspnea Scores Time: Week 24Description: Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.
Measure: Composite physiological index 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.
NCT04326036 Pulmonary Alveolar Proteinosis COPD Idiopathic Pulmonary Fibrosis Viral Pneumonia Coronavirus Infection Interstitial Lung Disease Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Device: Centricyte 1000 Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution Drug: Liberase Enzyme (Roche) Drug: Sterile Normal Saline for Intravenous Use MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
HPO:Abnormal lung morphology Interstitial pneumonitis Interstitial pulmonary abnormality Intraalveolar phospholipid accumulation Pulmonary fibrosis
Primary Outcomes
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 month
Secondary Outcomes
Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measure: Pulmonary Function Analysis Time: baseline, 3 Month, 6 months
Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 months
3 Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study
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 monthSecondary 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 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.
NCT04338802 COVID-19 Nintedanib Safety Effect of Drugs Drug: Nintedanib 150 MG Other: Placebo MeSH:Pulmonary Fibrosis
HPO:Pulmonary fibrosis
Primary Outcomes
Description: Changes in forced vital capacity (FVC) after treatment compared to baseline.
Measure: Changes in forced vital capacity (FVC) Time: 8 weeks
Secondary Outcomes
Description: Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.
Measure: Changes in carbon monoxide dispersion (DLco%) Time: 8 weeks
Description: Changes in the six-minute walk test (6MWT) after treatment compared to baseline.
Measure: Changes in the six-minute walk test (6MWT) Time: 8 weeks
Description: Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result
Measure: Changes in High resolution CT score Time: 8 weeks
4 STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
Primary Outcomes
Description: Changes in forced vital capacity (FVC) after treatment compared to baseline.
Measure: Changes in forced vital capacity (FVC) Time: 8 weeksSecondary Outcomes
Description: 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.
NCT04409275 Pulmonary Fibrosis MeSH:Pulmonary Fibrosis
HPO:Pulmonary fibrosis
Primary Outcomes
Description: To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2
Measure: Pulmonary fibrotic changes, short and medium term Time: 12 months
Description: To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.
Measure: Degree of lung function impairment Time: 6 and 12 months
Description: Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.
Measure: Biological markers Time: 1 month
5 Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection
Primary Outcomes
Description: To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2
Measure: Pulmonary fibrotic changes, short and medium term Time: 12 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.
NCT04416100 Covid-19 Pulmonary Fibrosis Diagnostic Test: Pulmonary function tests Diagnostic Test: Imaging Biological: Blood sampling MeSH:Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial
HPO:Abnormal lung morphology Interstitial pneumonitis Interstitial pulmonary abnormality Pulmonary fibrosis
Primary Outcomes
Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 1 month after discharge or diagnosis of COVID-19 disease by the use of HR-CT.
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month Time: 1 month
Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 3 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months Time: 3 months
Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 6 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months Time: 6 months
6 A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients
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 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 monthsRandomized, double-blinded, placebo-controlled, two-arm study to evaluate the effectiveness and safety of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in 2019 Coronavirus Disease (COVID-19) patients recently discharged from the hospital. Patients will be randomized 1:1 to receive BIO 300 or placebo. All patients will receive the same background current standard of care.
NCT04482595 Pulmonary Fibrosis Drug: BIO 300 Oral Suspension Drug: Placebo MeSH:Pulmonary Fibrosis
HPO:Pulmonary fibrosis
Primary Outcomes
Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 12 Weeks
Description: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 12 Weeks
Secondary Outcomes
Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 6 Months and 12 Months
Description: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 6 Months and 12 Months
Description: Forced vital capacity (FVC)
Measure: Change in FVC Time: 12 Weeks, 6 Months and 12 Months
Description: Forced expiratory volume in one second (FEV1)
Measure: Change in FEV1 Time: 12 Weeks, 6 Months and 12 Months
Description: Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)
Measure: Change in FEV1/FVC Ratio Time: 12 Weeks, 6 Months and 12 Months
Description: Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)
Measure: Change in Pulse Oximetry at Rest and During the 6MWT Time: 12 Weeks, 6 Months and 12 Months
Description: Evidence of pulmonary fibrosis on computerized tomography (CT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
Measure: Change in Pulmonary Fibrosis on CT Scan Time: 12 Weeks, 6 Months and 12 Months
Description: Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.
Measure: Change in St. George's Respiratory Questionnaire (SGRQ) Scores Time: 12 Weeks, 6 Months and 12 Months
Description: Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)
Measure: Change in Clinical Laboratory Values for Serum Enzymes Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Description: Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)
Measure: Change in Clinical Laboratory Values Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Description: Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)
Measure: Change in Clinical Laboratory Values Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Description: Monitoring of blood serum levels for albumin (g/dL)
Measure: Change in Clinical Laboratory Values for Albumin Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Description: Monitoring of white blood cell, red blood cell and platelet counts
Measure: Change in Complete Blood Counts with Differential Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Description: Mortality at 12 months after initiating treatment
Measure: All-Cause Mortality Time: 12 Months
Description: Incidence of hospitalization after initial discharge and initiating treatment
Measure: Incidence of Re-Hospitalization Time: 12 Months
Description: Evaluate the safety of BIO 300 Oral Suspension treatment
Measure: Adverse Events Related to BIO 300 Oral Suspension Time: 12 Months
Other Outcomes
Description: Duration of supplemental oxygen use
Measure: Change in Duration of Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 Months
Description: Prescribed supplemental oxygen flow rate at night, rest and exertion
Measure: Change in Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 Months
Description: Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)
Measure: Change in Serum Cytokine Expression Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
7 Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands
Primary Outcomes
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 WeeksSecondary Outcomes
Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 6 Months and 12 MonthsDescription: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 6 Months and 12 MonthsDescription: Forced vital capacity (FVC)
Measure: Change in FVC Time: 12 Weeks, 6 Months and 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: 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: Evidence of pulmonary fibrosis on computerized tomography (CT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
Measure: Change in Pulmonary Fibrosis on CT Scan Time: 12 Weeks, 6 Months and 12 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: 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 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 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: Mortality at 12 months after initiating treatment
Measure: All-Cause Mortality Time: 12 MonthsDescription: Incidence of hospitalization after initial discharge and initiating treatment
Measure: Incidence of Re-Hospitalization Time: 12 MonthsDescription: Evaluate the safety of BIO 300 Oral Suspension treatment
Measure: Adverse Events Related to BIO 300 Oral Suspension Time: 12 MonthsOther Outcomes
Description: Duration of supplemental oxygen use
Measure: Change in Duration of Supplemental Oxygen Use Time: 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: 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.
NCT04488562 COVID-19 Pulmonary Fibrosis MeSH:Pulmonary Fibrosis
HPO:Pulmonary fibrosis
Primary Outcomes
Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
Measure: VAS Time: 3 months
Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
Measure: VAS Time: 6 months
Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
Measure: VAS Time: 12 months
Description: Body temperature measured with an thermometer
Measure: Temperature Time: 3 months
Description: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 3 months
Description: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 6 months
Description: Oxygen saturation measured with an pulse oximeter
Measure: Oxygen measurements Time: 12 months
Description: FVC change measured with home spirometry at 3 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 3 months
Description: FVC change measured with home spirometry at 3 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 3 months
Description: FVC change measured with home spirometry at 6 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 6 months
Description: FVC change measured with home spirometry at 6 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 6 months
Description: FVC change measured with home spirometry at 12 months (in L)
Measure: Forced Vital Capacity (FVC) home spirometry in L Time: 12 months
Description: FVC change measured with home spirometry at 12 months (in %)
Measure: Forced Vital Capacity (FVC) home spirometry in % Time: 12 months
Description: FVC change measured with hospital spirometry and saturation at 3 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 3 months
Description: FVC change measured with hospital spirometry and saturation at 3 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 3 months
Description: FVC change measured with hospital spirometry and saturation at 6 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 6 months
Description: FVC change measured with hospital spirometry and saturation at 6 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 6 months
Description: FVC change measured with hospital spirometry and saturation at 12 months (in %)
Measure: Forced Vital Capacity (FVC) hospital spirometry in % Time: 12 months
Description: FVC change measured with hospital spirometry and saturation at 12 months (in L)
Measure: Forced Vital Capacity (FVC) hospital spirometry in L Time: 12 months
Description: The percentage of patients completed weekly home spirometry
Measure: Adherence to weekly home spirometry Time: 1 year after inclusion
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: Baseline
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: 6 weeks
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: 3 months
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: 6 months
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: 9 months
Description: The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status
Measure: EQ5D Time: 12 months
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: Baseline
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: 6 weeks
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: 3 months weeks
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: 6 months weeks
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: 9 months weeks
Description: Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Measure: FAS Time: 12 months weeks
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: Baseline
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: 6 weeks
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: 3 months
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: 6 months
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: 9 months
Description: Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from −7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Measure: GRoC Time: 12 months
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: Baseline
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: 6 weeks
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: 3 months
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: 6 months
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: 9 months
Description: Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.
Measure: ABC tool Time: 12 months
Secondary Outcomes
Description: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 3 months
Description: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 6 months
Description: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 12 months
Description: Predictors for the course of recovery of COVID-19 infection after hospital admission
Measure: Predictors for the course of recovery of COVID-19 infection after hospital admission Time: 12 months
Description: Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.
Measure: Satisfaction of patients and caregivers with the use of a home monitoring system Time: 12 months
HPO Nodes
HP:0002206: Pulmonary fibrosis
Genes 80
SFTPA2 NKX2-1 BMP15 TERT HPS4 IRF5 ALMS1 TINF2 PARN TERT TERT FSHR CAV1 CCN2 IRF5 TINF2 FASLG SP110 SFTPC ABCA3 KIAA0319L CASP10 CTLA4 FAS THOC2 BNC1 PARN TERC TERC CAV1 SFTPC RASGRP1 SFTPA1 TERC NOP10 RNF168 HLA-DRB1 SPIDR CLCA4 RNF168 POLR3H FAM13A STN1 PSMC3IP DSP RTEL1 HLA-DRB1 NHP2 MUC5B TERT NR5A1 CCR6 RTEL1 SFTPA2 DKC1 DCTN4 FAS CCR6 PLEC BTNL2 HLA-DPB1 MRPS22 HLA-DPA1 PTPN22 RCBTB1 CFTR PRKCD TERT ATP11A TGFB1 DPP9 CCN2 MUC5B NUP107 FAM111B PRTN3 AP3B1 HPS1 STX1A HLA-DRB1 Protein Mutations 1
V600E
Primary Outcomes
Description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
Measure: VAS Time: 3 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 monthsSecondary Outcomes
Description: Correlation between FVC, HRCT patterns, symptoms and quality of life
Measure: Correlation between FVC, HRCT patterns, symptoms and quality of life Time: 3 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 months