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D012120: Respiration Disorders

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (37)


Name (Synonyms) Correlation
drug4013 power breathe Wiki 0.22
drug2830 Remdesivir-HU Wiki 0.22
drug2189 Nintedanib Wiki 0.22
Name (Synonyms) Correlation
drug31 1: Usual practice Wiki 0.22
drug1761 Janus Kinase Inhibitor (ruxolitinib) Wiki 0.22
drug1908 LungFit™ Wiki 0.22
drug60 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki 0.22
drug2395 PT-Pal Wiki 0.22
drug517 Breath test Wiki 0.22
drug535 Bronchoalveolar Lavage (BAL) Wiki 0.22
drug45 2: Usual practice + SYMBICORT RAPIHALER Wiki 0.22
drug3532 Ulinastatin Wiki 0.22
drug2849 Respiratory and psychological rehabilitation Wiki 0.22
drug1156 Electrical Impedance Tomography (EIT) Wiki 0.22
drug1658 Inhaled Hypertonic ibuprofen Wiki 0.22
drug1667 Inspiratory training device Wiki 0.22
drug26 150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki 0.22
drug228 Angiotensin Receptor Blockers Wiki 0.22
drug2540 Placebo for Camostat Mesilate Wiki 0.22
drug1789 LYT-100 Wiki 0.22
drug950 Cross-sectional survey Wiki 0.22
drug1305 Fiberoptic Bronchoscopy (FOB) Wiki 0.22
drug3037 Self-guided exercises Wiki 0.22
drug282 Arterial Blood Gas test (ABG) Wiki 0.22
drug2201 Nitric Oxide delivered via LungFit™ system Wiki 0.22
drug1247 Expiratory training device Wiki 0.22
drug2693 Pulmonary Rehabilitation Wiki 0.16
drug899 Convalescent plasma Wiki 0.14
drug3958 no intervention Wiki 0.14
drug2025 Methotrexate Wiki 0.13
drug3196 Standard of Care (SoC) Wiki 0.13
drug4099 survey Wiki 0.08
drug686 Camostat Mesilate Wiki 0.07
drug2192 Nitazoxanide Wiki 0.06
drug2490 Placebo Wiki 0.05
drug1292 Favipiravir Wiki 0.05
drug1507 Hydroxychloroquine Wiki 0.02

Correlated MeSH Terms (15)


Name (Synonyms) Correlation
D012140 Respiratory Tract Diseases NIH 0.88
D056152 Respirat NIH 0.22
D053120 Respiratory Aspiration NIH 0.12
Name (Synonyms) Correlation
D011024 Pneumonia, Viral NIH 0.07
D005355 Fibrosis NIH 0.06
D017563 Lung Diseases, Interstitial NIH 0.06
D011658 Pulmonary Fibrosis NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D001523 Mental Disorders NIH 0.05
D003141 Communicable Diseases NIH 0.05
D018352 Coronavirus Infections NIH 0.05
D011014 Pneumonia NIH 0.05
D008171 Lung Diseases, NIH 0.05
D007239 Infection NIH 0.03
D013577 Syndrome NIH 0.02

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 0.06
HP:0002206 Pulmonary fibrosis HPO 0.06
HP:0002088 Abnormal lung morphology HPO 0.05
Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.05

Clinical Trials

Navigate: Correlations   HPO

There are 20 clinical trials


1 Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

NCT04326114
Conditions
  1. Disease, Infectious
  2. Respiratory Disease
  3. Safety Issues
  4. Effectiveness
Interventions
  1. Device: Inspiratory training device
  2. Device: Expiratory training device
MeSH:Communicable Diseases Infection Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Dichotomous categorical variable measured by "yes" or "no" responses

Measure: COVID-19 disease diagnosis

Time: Change from Baseline COVID-19 disease diagnosis at 8 weeks

Secondary Outcomes

Description: Dichotomous categorical variable measured by "slight" or "severe" responses

Measure: COVID-19 disease symptoms severity

Time: Change from Baseline COVID-19 disease symptoms severity at 8 weeks

Description: Polytomous categorical variable measured by adverse effects responses

Measure: Adverse effects

Time: Change from Baseline adverse effects at 8 weeks
2 Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)

On Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help. This study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.

NCT04329507
Conditions
  1. COVID-19
  2. Respiratory Disease
Interventions
  1. Diagnostic Test: Breath test
MeSH:Pneumonia Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: breath sample collection

Measure: To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without.

Time: up to daily during hospital admission

Secondary Outcomes

Description: breath sample collection

Measure: Detection of markers of Covid-19 pneumonia in non-invasive breath samples.

Time: multiple samples up to 60 days

Description: breath sample collection

Measure: Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs.

Time: multiple samples up to 60 days

Description: breath sample collection

Measure: Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored

Time: multiple samples up to 60 days

Description: breath sample collection

Measure: In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden .

Time: multiple samples up to 60 days
3 Protective Role of Inhaled Steroids for Covid-19 Infection

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

NCT04331054
Conditions
  1. Covid-19 Infection
  2. Hospitalization in Respiratory Disease Department
Interventions
  1. Drug: 2: Usual practice + SYMBICORT RAPIHALER
  2. Other: 1: Usual practice
MeSH:Infection Communicable Diseases Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.

Measure: Time (in days) to clinical improvement within 30 days after randomization

Time: within 30 days

Secondary Outcomes

Measure: Mortality rate at D30

Time: At day30

Measure: Time (in days) from randomization to death

Time: up to 30 days after randomization

Measure: Number of days alive outside ICU within 30 days

Time: At day30

Measure: Number of days alive free of invasive or non-invasive ventilation within 30 days

Time: At day30

Measure: Number of days alive with oxygen therapy within 30 days

Time: At day30

Measure: Maximal oxygen rate within 30 days

Time: At day30

Measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)

Time: at Day 7

Measure: Number of days alive outside hospital within 30 days

Time: at Day 30

Measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days

Time: at Day 30

Measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)

Time: at Day 7

Measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.

Time: up to 30 days after randomization
4 COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology

Prospective cohort study of COVID-19 infection among children in Norway.

NCT04335773
Conditions
  1. Pediatric Respiratory Diseases
  2. COVID
  3. Fatigue Post Viral
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Identify comorbidities predisposing for severe infection

Measure: Risk Factors for severe infection

Time: 2030

Description: Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.

Measure: Immunulogical mechanisms

Time: 2030

Description: prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue

Measure: Long term outcome

Time: 2030
5 Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.

The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.

NCT04382768
Conditions
  1. Coronavirus Infection
  2. Respiratory Disease
  3. SARS (Disease)
Interventions
  1. Drug: Inhaled Hypertonic ibuprofen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale

Measure: Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen.

Time: 7, 14 and 28 days

Description: Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart

Measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.

Time: 7, 14 and 28 days

Secondary Outcomes

Measure: Chage in length of Hospital stay

Time: 28 days

Measure: Chage in duration of ventilation

Time: 28 days

Measure: Chage in length of Critical Care stay

Time: 28 days

Description: NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care.

Measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28.

Time: 1, 7, 14 and 28

Description: qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not.

Measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.

Time: 1, 7, 14 and 28 days

Measure: Time from first dose to conversion to normal or mild pneumonia

Time: 28 days

Measure: Antibiotic requirement

Time: 28 days

Measure: Glucocorticoids requirement

Time: 28 days

Measure: Incidence of adverse event

Time: 28 days

Measure: Incidence of serious adverse event

Time: 28 days

Measure: Number of deaths from any cause at 28 days

Time: 28 days

Measure: Lymphocyte count

Time: 28 days
6 PRAISE@COVID-19: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation

This study applied the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) on respiratory patients who had their on-going ambulatory Pulmonary Rehabilitation program interrupted due to the COVID-19 outbreak. The research hypothesis is that ranking patients' self-efficacy is a useful screening tool to support patients' follow-up on a Pulmonary Rehabilitation telehealth solution to be explored during the COVID-19 outbreak.

NCT04388579
Conditions
  1. Respiratory Disease
Interventions
  1. Other: Pulmonary Rehabilitation
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Vincent and co-authors (2011) proposed the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE). The PRAISE tool is composed by a total of 15 items, combining 10 items from the General Self-Efficacy Scale (GSE) by Schwarzer and Jerusalem (1995), and 5 new specific items related to Pulmonary Rehabilitation. Each item is scored from 1 to 4 with a total range from 15 to 60, with higher scores indicating higher levels of self-efficacy. This study applies the Portuguese PRAISE version by Santos CD and co-authors (2019).

Measure: Patient's self-efficacy

Time: 3 days

Secondary Outcomes

Description: Patients were questioned if they were engaging on a daily routine of respiratory exercises by their initiative while isolated at home COVID-19 outbreak. The answer was registered as yes/no.

Measure: Respiratory exercises

Time: 3 days

Description: Patients were questioned if they managed to preserve a daily period to practice physical activity while isolated at home during COVID-19 outbreak. The answer was recorded as yes/no. In case of a positive answer, information concerning available equipment and exercise protocol adopted at patient's home environment was also collected.

Measure: Physical activity

Time: 3 days

Other Outcomes

Description: Number of Pulmonary Rehabilitation hospital sessions completed as outpatient, according to Hospital Pulido Valente information system

Measure: Treatment sessions completed

Time: 3 days

Description: Number of Pulmonary Rehabilitation sessions planned per week, according to Hospital Pulido Valente information system

Measure: Treatment weekly frequency

Time: 3 days
7 Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease

The Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.

NCT04394117
Conditions
  1. SARS-Cov-2
  2. COVID-19
Interventions
  1. Drug: Angiotensin Receptor Blockers
  2. Other: Placebo
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;

Measure: 7-Point National Institute of Health Clinical Health Score

Time: 14 Days

Secondary Outcomes

Description: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;

Measure: 7-Point National Institute of Health Clinical Health Score

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality

Measure: Mortality

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality

Measure: Mortality

Time: 90 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission

Measure: Intensive Care Unit Admission

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission

Measure: Intensive Care Unit Admission

Time: 90 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the number of days total, of intensive care unit admission

Measure: Intensive Care Unit Number of Days

Time: 90 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the incidence of respiratory failure

Measure: Respiratory Failure

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the requirements for dialysis

Measure: Dialysis Requirement

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days

Measure: Hospitalisation Days

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days

Measure: Hospitalisation Days

Time: 90 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes need for ventilation

Measure: Ventilator-Free Days

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes need for dialysis

Measure: Dialysis Days

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes risk of acute kidney injury, based on the idney Disease: Improving Global Outcomes definition

Measure: Acute Kidney Injury

Time: 28 Days

Description: To determine whether the addition of the intervention, compared to standard care, changes risk of hypotension requiring vasopressors

Measure: Hypotension Requiring Vasopressors

Time: 28 Days

Other Outcomes

Description: To determine whether the addition of the intervention, compared to standard care, changes risk of hyperkalaemia.

Measure: Hyperkalaemia

Time: Day 28

Description: To determine whether the addition of the intervention, compared to standard care, changes risk of decreased oxygen saturation

Measure: Oxygen Saturation

Time: Day 28

Description: To determine whether the addition of the intervention, compared to standard care, changes risk of decreased oxygen saturation

Measure: Oxygen Saturation

Time: Day 14
8 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04397692
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS-CoV 2
  4. Nitric Oxide
  5. Respiratory Disease
  6. Pneumonia, Viral
  7. Inhaled Nitric Oxide
Interventions
  1. Device: Nitric Oxide delivered via LungFit™ system
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disord Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration measured by need for NIV, HFNC or intubation

Measure: Time to deterioration

Time: 14 Days

Secondary Outcomes

Description: Time to non-invasive ventilation

Measure: Time to NIV

Time: 14 Days

Description: Time to high flow nasal cannula

Measure: Time to HFNC

Time: 14 Days

Description: Time to intubation

Measure: Time to intubation

Time: 14 days

Description: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Time: 14 days

Other Outcomes

Description: Need for supplemental oxygen

Measure: Need for supplemental oxygen

Time: 14 days

Description: Change in viral load

Measure: Change in viral load

Time: 30 days

Description: Duration of the Hospital Length of Stay (LOS)

Measure: Duration of the Hospital Length of Stay (LOS)

Time: 14 days

Description: Mortality rate at Day 30

Measure: Mortality rate at Day 30

Time: 30 days
9 Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms

A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known. The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form. This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.

NCT04407169
Conditions
  1. COVID
Interventions
  1. Other: no intervention
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.

Measure: Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale

Time: up to 28 days (during hospitalisation)

Secondary Outcomes

Description: Radiological damage (extension of ground-glass) could be a predictive factor.

Measure: Determined potential predictive factors of critic form in patients with chronic lung diseases

Time: up to 28 days (during hospitalisation)

Description: intra-hospital death, intra-ICU death

Measure: Determined percentage of death

Time: up to 28 days (during hospitalisation)

Description: in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)

Measure: Determined duration of oxygen therapy

Time: up to 28 days (during hospitalisation)

Description: in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.

Measure: Determined duration of hospitalization

Time: up to 28 days (during hospitalisation)

Description: values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement

Measure: Determine mean values of the WHO CoVid-19 infection progression scale measured

Time: up to 28 days (during hospitalisation)
10 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2

The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04456088
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Corona Virus Infection
Interventions
  1. Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System
  2. Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration as measured by any one of the following: need for non-invasive ventilation need for high flow nasal cannula (HFNC) or need for intubation Death from any cause

Measure: Time to deterioration

Time: up to 14 days

Secondary Outcomes

Description: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air

Measure: Time to stable oxygen saturation

Time: up to 14 days

Other Outcomes

Description: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment

Measure: Treatment Emergent Adverse Events and SAEs

Time: 30 days after last inhalation treatment
11 Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

NCT04477993
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. SARS-CoV2
Interventions
  1. Drug: Janus Kinase Inhibitor (ruxolitinib)
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases Syndrome

Primary Outcomes

Measure: A composite outcome of death or ICU admission or mechanical ventilation at day 14.

Time: 14 days

Secondary Outcomes

Measure: A composite outcome of death or ICU admission or mechanical ventilation at day 28

Time: 28 days

Description: ICU admission, mechanical ventilation, death or consent withdrawal

Measure: Time to treatment failure

Time: 28 days

Measure: Overall survival at days 14 and 28

Time: 14 and 28 days

Measure: Cumulative incidence of ICU admission rate at days 14 and 28

Time: 14 and 28 days

Measure: Cumulative incidence of mechanical ventilation at days 14 and 28

Time: 14 and 28 days

Measure: Duration of hospital stay

Time: 28 days

Measure: Duration of ICU stay

Time: 28 days

Measure: Duration of mechanical ventilation

Time: 28 days

Measure: Duration of non-invasive ventilation

Time: 28 days

Measure: Secondary hemophagocytic syndrome rate

Time: 28 days

Measure: Cumulative incidence nosocomial infection rate at days 14 and 28

Time: 14 and 28 days

Measure: Incidence of discontinuation of oxygen supplementation at days 14 and 28

Time: 14 and 28 days

Measure: Rate of grade 1-2 and 3-5 emerging adverse events at day 28

Time: 28 days

Measure: Cumulative dose of methylprednisolone at days 14 and 28

Time: 14 and 28 days

Measure: Change in PaO2/FiO2 ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in d-dimer levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in ferritin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in C reactive protein levels [mg/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in alanine aminotransferase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in creatinine levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in glucose levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in hemoglobin levels [g/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in prothrombin time ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in partial thromboplastin time ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in bilirubin [mg/dl] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in CPK-MB [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in troponin [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in ADAMTS-13 [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand multimeters from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in E-selectin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in P-selectin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in endothelin [fmol/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in circulating microparticles from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in thromboelastography from baseline to days 14 and 28

Time: 14 and 28 days
12 Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients: Impact on Respiratory Mechanics and Gas Exchange

Fiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.

NCT04502368
Conditions
  1. Fiberoptic Bronchoscopy (FOB)
  2. Bronchoalveolar Lavage (BAL)
  3. Respiratory Disease
Interventions
  1. Procedure: Fiberoptic Bronchoscopy (FOB)
  2. Procedure: Bronchoalveolar Lavage (BAL)
  3. Diagnostic Test: Electrical Impedance Tomography (EIT)
  4. Diagnostic Test: Arterial Blood Gas test (ABG)
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: The variation of regional compliance, calculated by electrical impedance

Measure: Regional Compliance Variation

Time: From FOB/BAL to 6 hours later

Secondary Outcomes

Description: The variation of regional resistance, calculated by electrical impedance

Measure: Regional Resistance Variation

Time: From FOB/BAL to 6 hours later

Description: Relation between regional compliance variation and FOB duration

Measure: Regional Compliance and FOB duration

Time: From FOB/BAL to 6 hours later

Description: Relation between regional compliance variation and PaO2 variation

Measure: Regional Compliance and PaO2

Time: From FOB/BAL to 6 hours later

Description: Relation between atelectasis impedance-detected areas and BAL flooded impedance-detected areas

Measure: Atelectasis areas and BAL flooded areas

Time: From FOB/BAL to 6 hours later

Description: Variation of PaO2 and PaO2/FiO2 ratio post FOB/BAL

Measure: PaO2 and PaO2/FiO2 ratio

Time: From FOB/BAL to 6 hours later

Description: Variation of PaCO2 post FOB/BAL

Measure: PaCO2

Time: From FOB/BAL to 6 hours later

Description: Relation between the endotracheal tube/fiberscope size ratio and gas exchanges

Measure: Endotracheal tube size and Fiberscope size

Time: From FOB/BAL to 6 hours later

Description: Heart rate (HR), Blood Pressure (BP)

Measure: Hemodynamic variations

Time: From FOB/BAL to 6 hours later
13 Evaluation of the Response of COVID-19 Spread With a Spatiotemporal Analysis in a Tertiary Hospital

One of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.

NCT04581096
Conditions
  1. Covid19
  2. Spatial Visualization
  3. Neural Network
  4. Respiratory Disease
  5. Pandemic
  6. Disease Spread
Interventions
  1. Other: no intervention
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: spatiotemporal spread of COVID-19 patient in our hospital

Measure: spatiotemporal spread

Time: February 1, 2020 to September 30, 2020

Secondary Outcomes

Description: risk classification score of each patients with clinical and analytical variables

Measure: classification score

Time: February 1, 2020 to September 30, 2020
14 Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study

COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.

NCT04603963
Conditions
  1. Covid19
  2. Respiratory Disease
Interventions
  1. Device: power breathe
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: respiratory muscle training appears to impact functionality

Measure: impact on functionality

Time: 14 days
15 Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia

The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia

NCT04606407
Conditions
  1. Viral Pneumonia
  2. Nitric Oxide
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Inhaled Nitric Oxide
  6. Covid19
  7. SARS-CoV Infection
Interventions
  1. Device: LungFit™
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Measure: incidence of Serious Adverse Events

Time: 30 days

Secondary Outcomes

Description: Time to fever resolution

Measure: fever resolution

Time: Baseline to 30 days

Description: Number of patients requiring admission to ICU

Measure: ICU admission

Time: Baseline to 30 days

Description: Time until patient no longer requires supportive oxygen

Measure: Oxygen support

Time: Baseline to 30 days

Description: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Measure: Stable room air saturation

Time: Baseline to 30 days
16 Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis

This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.

NCT04619680
Conditions
  1. Pulmonary Fibrosis
  2. Interstitial Lung Disease
  3. Respiratory Disease
Interventions
  1. Drug: Nintedanib
  2. Drug: Placebo
MeSH:Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial Respiration Disorders Respiratory Tract Diseases Fibrosis
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pulmonary fibrosis

Primary Outcomes

Description: Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.

Measure: Change in Forced Vital Capacity (FVC)

Time: Baseline and 180 days

Secondary Outcomes

Description: Death within 90 days and 180 days from enrollment due to a respiratory cause

Measure: Number of deaths due to respiratory cause

Time: within 90-180 days

Description: Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.

Measure: Chest CT visual score

Time: 180 days

Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.

Measure: St. George's Respiratory Questionnaire (SGRQ)

Time: Day 90

Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.

Measure: St. George's Respiratory Questionnaire (SGRQ)

Time: Day 180

Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.

Measure: King's Brief Interstitial Lung Disease (KBILD)

Time: Day 90

Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.

Measure: King's Brief ILD (KBILD)

Time: Day 180

Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.

Measure: Leicester Cough Questionnaire (LCQ)

Time: Day 90

Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.

Measure: Leicester Cough Questionnaire

Time: Day 180

Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.

Measure: Short Form (SF) 36 Health Survey

Time: Day 90

Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.

Measure: SF 36 Health Survey

Time: Day 180

Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 90

Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 180

Description: Number of participants with Increase in liver transaminases

Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal

Time: day 90

Description: Number of participants with Increase in liver transaminases

Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal

Time: day 180

Description: Number of participants with Thrombotic events: venous or arterial thrombosis

Measure: Number of participants with Thrombotic events

Time: day 90

Description: Number of participants with Thrombotic events: venous or arterial thrombosis

Measure: Number of participants with Thrombotic events

Time: day 180

Description: Number of participants with 10% weight loss

Measure: Number of participants with 10% weight loss over 90 days

Time: day 90

Description: Number of participants with 10% weight loss

Measure: Number of participants with 10% weight loss over 90 days

Time: day 180

Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents

Measure: Number of participants with GI events

Time: day 90

Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents

Measure: Number of participants with GI events

Time: day 180
17 Prevalence of Altered Pulmonary Function Post-infection by COVID-19 and Impact of Participation in a Pilot Program of Comprehensive Rehabilitation in the Short and Medium-term

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.

NCT04649736
Conditions
  1. Covid19
  2. Respiratory Disease
  3. Mental Health Disorder
Interventions
  1. Other: Respiratory and psychological rehabilitation
MeSH:Respiration Disorders Respiratory Tract Diseases Mental Disorders

Primary Outcomes

Description: Distance walked during 6-minutes (meters)

Measure: Six minute walk distance

Time: Change from baseline measure at hospital discharge to week 6 and 12

Secondary Outcomes

Description: The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms)

Measure: Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms.

Measure: Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms.

Measure: Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life

Measure: Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually.

Measure: Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: Measured in milliliters by dynamic spirometry

Measure: Forced expiratory volume in the first second

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: Measured in milliliters by dynamic spirometry

Measure: Forced Vital Capacity

Time: Change from baseline measure at hospital discharge to week 6 and 12

Description: IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress).

Measure: Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.

Time: Change from baseline measure at hospital discharge to week 6 and 12
18 A Phase 2 Randomized, Double-blind, Placebo-controlled Safety and Efficacy Trial of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease

This study is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications

NCT04652518
Conditions
  1. Covid19
Interventions
  1. Drug: LYT-100
  2. Other: Placebo
MeSH:Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: The 6MWT is a validated endpoint commonly used in clinical trial research

Measure: Change in distance walked on the six-minute walk test (6MWT)

Time: Baseline to Day 91

Secondary Outcomes

Description: The mBDS is an assessment tool that analyzes breathlessness under exertion

Measure: Change in Modified Borg Dyspnoea Scale (mBDS) score

Time: Baseline to Day 91

Description: The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being and overall evaluation of health in 8 domains

Measure: Quality of Life assessment as collected using the SF-36

Time: Baseline to Day 91
19 Effects of Interventions and Lifestyle Modifications in Integrative Medicine and the Course of Infectious Respiratory Diseases Including COVID-19

The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international proportions when it was declared by the World Health Organization (WHO) in January 2020. Since then, the virus has spread internationally and the WHO has classified the outbreak as a pandemic. In the context of the increasing reporting of this pandemic and the increasing governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is so far little scientific evidence for the effects of a healthy lifestyle on the disease. The aim of this study is to compare the potential of different, possibly protective lifestyles using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000 participants using mobile website technology.

NCT04653727
Conditions
  1. Covid19
  2. Influenza A
  3. Respiratory Disease
Interventions
  1. Other: Cross-sectional survey
MeSH:Resp Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Measure: SARS-CoV-2 infection

Time: Assessed retrospectively (last 6 months) with self-designed question

Secondary Outcomes

Measure: Influenza virus infection

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Other respiratory infections

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Dietary habits

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Sports activity

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Time spent in nature

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of hydrotherapy/Kneipp applications

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of anthroposophic medicine

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of digital health services

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of phytotherapy

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of dietary supplements

Time: Assessed retrospectively (last 6 months) with self-designed question

Description: The scale ranges from 0 to 100, where 0 is the lowest level of well-being / lowest quality of life and 100 is the highest level of well-being / highest quality of life.

Measure: WHO-5 Well-Being Index

Time: Assessed when filling out the questionnaire (Baseline)

Description: The NAS ranges from 0 to 10, where 0 is the lowest level of stress and 10 is the highest level of stress.

Measure: Numeric analog scale (NAS) stress

Time: Assessed retrospectively (last 6 months) with self-designed question

Description: The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.

Measure: Numeric analog scale (NAS) anxiety

Time: Assessed retrospectively (last 6 months) with self-designed question

Description: The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.

Measure: Numeric analog scale (NAS) depression

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Use of relaxation / mind body approaches

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Alcohol consumption

Time: Assessed retrospectively (last 6 months) with self-designed question

Measure: Cigarette consumption

Time: Assessed retrospectively (last 6 months) with self-designed question

Description: The scale ranges from 0 to 100, where 0 is the lowest level of self-efficacy and 100 is the highest level of self-efficacy.

Measure: Self-efficacy

Time: Assessed when filling out the questionnaire (Baseline)

Measure: Sick leave

Time: Assessed retrospectively (last 6 months) with self-designed question

Other Outcomes

Measure: Qualitative interviews

Time: Conducted 1 month after completion of the questionnaire (once)
20 Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

NCT04681430
Conditions
  1. Corona Virus Infection
  2. SARS-CoV-2 Infe
  3. SARS-CoV-2 Infection
  4. SARS-CoV-2 PCR Test Positive
  5. SARS-CoV-2 Acute Respiratory Disease
Interventions
  1. Biological: Convalescent plasma
  2. Drug: Camostat Mesilate
  3. Drug: Placebo for Camostat Mesilate
  4. Other: Standard of Care (SoC)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28

Measure: WHO ordinal Covid-19 scale up to day 28

Time: up to and including day 28

Secondary Outcomes

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8

Measure: Cumulative number WHO categories 4b-8

Time: day 8, day 14, day 56 and day 90

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a

Measure: Cumulative number WHO categories 3-4a

Time: day 8, day 14, day 28, day 56 and day 90

Description: Cumulative number of participants not hospitalized at day 90

Measure: Not hospitalized

Time: at day 90

Description: All-cause mortality at day 90

Measure: All-cause mortality

Time: at day 90

Description: Number of patient with SARS-CoV-2 reinfection up to day 90

Measure: Reinfection

Time: up to day 90

Description: Number of patient with secondary sclerosis cholangitis at day 90

Measure: Secondary sclerosing cholangitis (SSC)

Time: at day 90

Description: Number of patient with COVID-19 associated chronic pulmonary disease

Measure: chronic pulmonary disease as sequelae from COVID-19

Time: at day 90

Description: The proportion of patients with remdesivir therapy

Measure: patients with remdesivir treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of remdesivir treatment

Time: up to day 90

Description: The proportion of patients on dexamethasone therapy

Measure: patients with dexamethasone treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of dexamethasone treatment

Time: up to day 90

Description: Time to resolution of COVID-19 related symptoms (e.g. fever)

Measure: resolution of COVID-19 symptoms

Time: until day of resolution up to day 90

Description: Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)

Measure: negative SARS-CoV-2-PCR test

Time: until day of first negative test up to day 90

Description: Duration of oxygen therapy (in days)

Measure: Oxygen therapy

Time: number of days with oxygen therapy up to day 90

Description: Frequency of occurrence of COVID-19 pneumonia

Measure: COVID-19 pneumonia

Time: up to day 90

Description: Percentage of participants in each group with need for mechanical ventilation

Measure: Percentage of participants requiring mechanical ventilation

Time: up to day 90

Description: Number of ventilation days per participant up to day 90

Measure: Number of ventilation days per participant up to day 90

Time: up to day 90

Description: Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)

Measure: hospital stay and intensive care

Time: up to day 90

Description: All-cause mortality at day 28

Measure: Mortality

Time: at day 28

Description: Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up

Measure: SAEs

Time: up to day 90

Description: Cumulative incidence of grade 3/4 Adverse Events (AE) per group

Measure: Grade 3/4 AEs

Time: up to day 90

Description: SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgA concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgG concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 neutralizing antibody titers

Time: on day 8, day 14, day 90

Description: Number of screening failures due to the lack of a suitable plasma preparation

Measure: Plasma treatment screening failures

Time: up to day 8 (End of treatment)

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook