CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0006515: Interstitial pneumonitisHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (20)


Name (Synonyms) Correlation
drug1951 Pulmonary ultrasound Wiki 0.32
drug967 Fourth Trimester Mobile Tool Wiki 0.32
drug1340 Liberase Enzyme (Roche) Wiki 0.32
drug2205 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.32
drug146 Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Wiki 0.32
drug1160 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.32
drug1487 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.32
drug567 Chloroquine or hydroxychloroquine Wiki 0.32
drug762 Diet tracking and survey Wiki 0.32
drug2349 Standard treatment according to the Clinical protocols Wiki 0.32
drug1950 Pulmonary function tests Wiki 0.32
drug2361 Sterile Normal Saline for Intravenous Use Wiki 0.32
drug537 Centricyte 1000 Wiki 0.32
drug809 EHR-based Clinician Jumpstart Wiki 0.32
drug2833 high-titer anti-Sars-CoV-2 plasma Wiki 0.32
drug1175 Imaging Wiki 0.32
drug2939 oxygen therapy Wiki 0.22
drug2538 Tofacitinib Wiki 0.22
drug386 Blood sampling Wiki 0.18
drug1086 Hydroxychloroquine Wiki 0.03

Correlated MeSH Terms (28)


Name (Synonyms) Correlation
D017563 Lung Diseases, Interstitial NIH 1.00
D008171 Lung Diseases, NIH 0.33
D001469 Barotrauma NIH 0.32
D011649 Pulmonary Alveolar Proteinosis NIH 0.32
D054990 Idiopathic Pulmonary Fibrosis NIH 0.32
D011658 Pulmonary Fibrosis NIH 0.28
D001987 Bronchiectasis NIH 0.22
D014652 Vascular Diseases NIH 0.22
D016491 Peripheral Vascular Diseases NIH 0.22
D004646 Emphysema NIH 0.22
D058729 Peripheral Arterial Disease NIH 0.18
D009362 Neoplasm Metastasis NIH 0.18
D011024 Pneumonia, Viral NIH 0.16
D051437 Renal Insufficiency, NIH 0.16
D008175 Lung Neoplasms NIH 0.16
D008103 Liver Cirrhosis, NIH 0.16
D011014 Pneumonia NIH 0.13
D007676 Kidney Failure, Chronic NIH 0.13
D006333 Heart Failure NIH 0.12
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.11
D053717 Pneumonia, Ventilator-Associated NIH 0.11
D002908 Chronic Disease NIH 0.10
D007251 Influenza, Human NIH 0.10
D009369 Neoplasms, NIH 0.07
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 (12)


Name (Synonyms) Correlation
HP:0002088 Abnormal lung morphology HPO 0.33
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.32
HP:0002206 Pulmonary fibrosis HPO 0.28
HP:0002110 Bronchiectasis HPO 0.22
HP:0000083 Renal insufficiency HPO 0.16
HP:0001395 Hepatic fibrosis HPO 0.16
HP:0100526 Neoplasm of the lung HPO 0.16
HP:0004950 Peripheral arterial stenosis HPO 0.14
HP:0002090 Pneumonia HPO 0.13
HP:0001635 Congestive heart failure HPO 0.12
HP:0006510 Chronic pulmonary obstruction HPO 0.11
HP:0002664 Neoplasm HPO 0.07

There are 10 clinical trials

Clinical Trials


1 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

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

NCT04281784 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure,Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart
MeSH:Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

Primary Outcomes

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

Measure: EHR documentation of Goals of Care discussions

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

Secondary Outcomes

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

Measure: Intensity of care/ICU use: ICU admissions

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

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

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

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

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

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

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

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

Measure: Intensity of care: Hospital Readmissions 30 days

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

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

Measure: Intensity of care: ICU Readmissions 30 days

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

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

Measure: Intensity of care: Healthcare costs

Time: 1 and 3 months after randomization

Description: From Washington State death certificates.

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

Time: 1 year after randomization

Other Outcomes

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

Measure: Key Implementation Factors

Time: 3 months after randomization

2 The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations

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

NCT04313946 COVID-19 Pneumonia, Viral Influenza With Pneumonia Flu Symptom Flu Like Illness Pneumonia, Interstitial Pneumonia, Ventilator-Associated Pneumonia Atypical Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, V Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

Measure: COVID-19 positive X-Rays

Time: 6 months

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

Measure: COVID-19 negative X-Rays

Time: 6 months

3 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036 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

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

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

NCT04333251 Pneumonia, Interstitial Biological: high-titer anti-Sars-CoV-2 plasma Other: oxygen therapy
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

Description: reduction in oxygen and ventilation support

Measure: reduction in oxygen and ventilation support

Time: through study completion, an average of 4 weeks

5 Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +

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

NCT04335019 2019-nCoV (COVID-19) Interstitial Pneumonia Other: Pulmonary ultrasound
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

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

Time: at day0

Secondary Outcomes

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

Time: at day0

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

Time: at day0

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

Time: at day5

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

Time: at day15

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

Time: at day28

6 Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

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

NCT04382547 COVID Covid-19 Coronavirus Pneumonia Pneumonia, Viral Pneumonia, Interstitial Sars-CoV2 Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Other: Standard treatment according to the Clinical protocols
MeSH:Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

Measure: Number of cured patients

Time: 3 weeks

Secondary Outcomes

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

Measure: Number of patients with treatment-related adverse events

Time: 3 weeks

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

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

NCT04390061 Pneumonitis, Interstitial COVID-19 Drug: Tofacitinib Drug: Hydroxychloroquine
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

Measure: Prevention of severe Respiratory Failure requiring mechanical ventilation

Time: 14 days

Secondary Outcomes

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

Measure: Prevention of need of ICU admission

Time: 28 days

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

Measure: Prevention of COVID-19 related Deaths

Time: 28 days

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

Measure: Identification of predictors of outcome

Time: 14 days

Description: Rate of severe drug-related adverse events

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 28 days

8 Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection

COVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.The most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms. Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both. Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.

NCT04416100 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

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

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

NCT04435327 COVID Pneumonia, Viral Barotrauma Interstitial Lung Disease Bronchiectasis Adult Emphysema
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Bronchiectasis Lung Diseases, Interstitial Emphysema Barotrauma
HPO:Abnormal lung morphology Bronchiectasis Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

Description: Reduction below 80% of predicted values of DLCO

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

Time: T1 at 6 months from discharge

Description: Reduction below 80% of predicted values of DLCO

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

Time: T2 at 12 months from discharge

Secondary Outcomes

Description: reduction in maximum distance walked

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

Time: T1 at 6 months from discharge

Description: reduction in maximum distance walked

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

Time: T2 at 12 months from discharge

Description: reduction in oxygen saturation nadir

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

Time: T1 at 6 months from discharge

Description: reduction in oxygen saturation nadir

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

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV,%)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

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

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

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

Measure: Abnormal Dyspnea Score

Time: T1 at 6 months from discharge

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

Measure: Abnormal Dyspnea Score

Time: T2 at 12 months from discharge

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

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

Time: T1 at 6 months from discharge

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

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

Time: T2 at 12 months from discharge

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

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

Time: T1 at 6 months from discharge

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

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

Time: T2 at 12 months from discharge

10 Identification of Predictors for the Evolution of COVID-19 Related Interstitial Pneumonia by Transcriptomic and Seroproteomic Techniques

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

NCT04441502 Covid19 Interstitial Pneumonia
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

Measure: Circulating markers for COVID-19 signature

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

Secondary Outcomes

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

Measure: COVID-19 signature and adverse cardiovascular events

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

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

Measure: COVID-19 related coagulation pattern

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


HPO Nodes