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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3631 | Relaxation Breathing Wiki | 0.23 |
| drug2813 | Nitric Oxide delivered via LungFit™ system Wiki | 0.23 |
| drug4686 | Vital sign measurement Wiki | 0.23 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4999 | inhaled hydroxychloroquine Wiki | 0.23 |
| drug3966 | Short acting beta agonist (SABA) (rescue medication) Wiki | 0.23 |
| drug3063 | PSG Wiki | 0.23 |
| drug3636 | Remdesivir (RDV) Wiki | 0.23 |
| drug4549 | UNI911 INHALATION Wiki | 0.23 |
| drug209 | Acetazolamide + supplemental oxygen + PAP therapy Wiki | 0.23 |
| drug2541 | Media Intervention Wiki | 0.23 |
| drug4235 | Systemic indirect endovenous ozone therapy Wiki | 0.23 |
| drug4727 | Water Without an Elevated Level of KELEA Wiki | 0.23 |
| drug2671 | Monodose RS01 Wiki | 0.23 |
| drug1545 | Ethanol with Asprin Wiki | 0.23 |
| drug2262 | KELEA Excellerated Water Wiki | 0.23 |
| drug2566 | Melphalan Wiki | 0.23 |
| drug796 | COVID-19 Androgen Sensitivity Test (CoVAST) Wiki | 0.23 |
| drug4968 | high-flow high humidity oxygen device with tracheostomy adapter Wiki | 0.23 |
| drug5001 | inspiratory muscle traiing Wiki | 0.23 |
| drug722 | Buspirone + PAP therapy Wiki | 0.23 |
| drug4795 | Zolpidem + PAP therapy Wiki | 0.23 |
| drug3737 | Run-in medications (ICS-LABA combination) Wiki | 0.23 |
| drug1761 | GSK3923868 Wiki | 0.23 |
| drug2552 | Meditation Therapy Wiki | 0.23 |
| drug2444 | LungFit™ Wiki | 0.23 |
| drug173 | AZD1402 Wiki | 0.23 |
| drug2139 | Inspiratory Muscle Training Wiki | 0.23 |
| drug3071 | PUL-042 Inhalation Solution Wiki | 0.16 |
| drug790 | COVID Convalescent Plasma Wiki | 0.16 |
| drug4441 | Tofacitinib 10 mg Wiki | 0.16 |
| drug2810 | Nitric Oxide Wiki | 0.11 |
| drug4773 | Yoga Wiki | 0.11 |
| drug2528 | Matching placebo Wiki | 0.11 |
| drug3484 | Quality-of-Life Assessment Wiki | 0.09 |
| drug3497 | Questionnaire Administration Wiki | 0.07 |
| drug4112 | Standard of care Wiki | 0.04 |
| drug3195 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020182 | Sleep Apnea, Central NIH | 0.23 |
| D001249 | Asthma NIH | 0.12 |
| D012120 | Respiration Disorders NIH | 0.10 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012891 | Sleep Apnea, NIH | 0.09 |
| D012140 | Respiratory Tract Diseases NIH | 0.08 |
| D011024 | Pneumonia, Viral NIH | 0.08 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.05 |
| D011014 | Pneumonia NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002871 | Central apnea HPO | 0.23 |
| HP:0002099 | Asthma HPO | 0.12 |
| HP:0010535 | Sleep apnea HPO | 0.09 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.05 |
| HP:0002090 | Pneumonia HPO | 0.04 |
Navigate: Correlations HPO
There are 19 clinical trials
Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.
Description: CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative.
Measure: CO2 reserve Time: 120 daysDescription: Central apnea indices is used to indicate the severity of central sleep apnea
Measure: Central apnea indices Time: 120 daysDescription: Controller gain is a ventilatory response to changes in end-tidal PCO2
Measure: Controller gain Time: 120 daysDescription: Plant gain is blood gas response to a change in ventilation. This measure represents the effectiveness of the "plant" in eliminating CO2.
Measure: Plant gain Time: 120 daysDescription: This measure represents the activity of the carotid bodies. It is measured by the decrease in ventilation in response to a single breath of 100% oxygen.
Measure: Carotid body function Time: 120 daysDescription: Peripheral chemoreflex sensitivity is measured either via brief hypoxia or a single breath of CO2.
Measure: Peripheral chemoreflex sensitivity Time: 120 daysDescription: The nadir pressure in the upper airway (supra-glottic pressure) prior to the occurrence of an arousal.
Measure: Respiratory arousal threshold Time: 120 daysDescription: To assess breathing stability, the investigators will measure % stable breathing using minute ventilation (VE) and tidal volume (VT) coefficient of variation as indices of breathing instability.
Measure: % stable breathing Time: 120 daysAdults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome
Description: To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection and, 2) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 or less) at the time of enrollment. The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
Measure: Severity of COVID-19 Time: 28 daysDescription: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
Measure: SARS-CoV-2 infection Time: 28 daysDescription: To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
Measure: Severity of COVID-19 over 14 days Time: 14 daysDescription: To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.
Measure: Severity of COVID-19 symptoms Time: 28 daysDescription: The requirement for ICU admission within 28 days from the start of the experimental therapy.
Measure: ICU admission Time: 28 daysDescription: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
Measure: Mechanical Ventilation Time: 28 daysDescription: All cause mortality at 28 days from the start of experimental therapy
Measure: Mortality Time: 28 daysMost patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
Description: Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.
Measure: Proportion of patients with altered spleep Time: At day 10 after inclusionDescription: Thanks to a PSG the night befor discharge, the seep architecture will be estimated.
Measure: Sleep architecture at hospital discharge Time: At day 28 after inclusionDescription: Thanks to actimetry measure during hospitalization in the post ICU ward.
Measure: Sleep monitoring during hospital stay after ICU discharge Time: At day 18 after ICU dischargeDescription: Sleep quality will be evaluate by the Pittsburgh sleep quality index. The 7 components of the score add up for give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Measure: Sleep quality Time: 3 months after hospiotal dischargeDescription: Thanks to a PSG at 3 months, the seep architecture will be estimated.
Measure: Sleep architecture at month-3 Time: 3 months after hospital dischargeDescription: all cost will be estimated during ICU hospitalization.
Measure: Cost of ICU hospitalization Time: From inclusion to ICU discharge, up to 10 days after inclusionThis single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.
Description: The number of patients with the clinical improvement is defined as an improvement of two points (from the status at baseline) on an ordinal scale of clinical improvement on day 28 or discharge from hospital ( whatever occurs earlier) Death Hospitalized with Invasive mechanical ventilation plus additional organ support - ECMO / pressors / RRT Hospitalized with intubation and mechanical ventilation Hospitalized on non-invasive ventilation or high flow oxygen. Hospitalized on a mask or nasal prongs. Hospitalized no oxygen therapy. Ambulatory, with limitation of activities. Ambulatory, no limitation of activities. I. No clinical or virological evidence of infection.
Measure: The changes of COVID Ordinal Outcomes Scale Time: baseline vs Day 14, day 28Description: Percentage of the patients with clinical recovery which is defined as a normalisation of fever, respiratory rate, and oxygen saturation, and improvement of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalization and improvement criteria: Fever - <37°C, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Percentage of the patients with Clinical Recovery Time: baseline vs day 7, day 14, day 28Description: The evaluation of changes in modified Borg dyspnea scale. From 0 to 10 units.A lower score means a better clinical result (0 is the absence of dyspnea, and 10 - is maximal dyspnea). Minimal clinically important difference is 1 unit.
Measure: The changes of the Borg's scale Time: Baseline vs day 7, day 14, day 28Description: Change in C-reactive protein (CRP) level from baseline in mg/ml. A lower level of CRP means a better clinical result.
Measure: CRP level Time: baseline, day 7, Day 14, Day 28Description: Change in blood absolute lymphocyte count from baseline. A higher number of lymphocytes means a better clinical result.
Measure: Lymphocyte count Time: baseline, day 7, Day 14, Day 28Description: Change in blood D-dimer level from baseline. A lower level of D-dimer means a better clinical result.
Measure: D-dimer Time: baseline, day 7, Day 14, Day 28Description: Change in peripheral blood IL-6 level from baseline. A lower level of IL-6 means a better clinical result.
Measure: IL-6 Time: baseline, day 7, Day 14, Day 28Description: Percentage of patients without artificial lung ventilation during the study. A lower percentage of patients means a better clinical result.
Measure: Percentage of patients without artificial lung ventilation Time: baseline, day 7, Day 14, Day 28This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.
Description: Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale (See statistical methods). Between-group differences in the average maximum disease severity assessed through 28 days, through the following severity scores: a) increased liter oxygen flow, through a high flow nasal cannula; b) non-invasive ventilation; c) intubation or institution of ECMO; or d) death.
Measure: Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale. Time: 28 daysThe 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.
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysDescription: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 DaysDescription: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 DaysDescription: Time to intubation
Measure: Time to intubation Time: 14 daysDescription: 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 daysDescription: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 daysDescription: Change in viral load
Measure: Change in viral load Time: 30 daysDescription: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 daysDescription: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 daysIn light of the corona virus pandemic (COVID-19), there is critical need to conserve scarce mechanical ventilation (MV) resources. This study evaluates an intervention in non-infected cardiac patients as a means to assist with minimizing MV and ICU length of stay (LOS). Pre-op inspiratory muscle training (IMT) has been shown to decrease pulmonary complications, MV dependence, and ICU LOS following thoracic surgery. The investigators aim to determine the mechanism of remodeling in diaphragms of adults who undergo pre-op IMT.
Description: Maximal inspiratory pressure will be quantified in cm of water pressure.
Measure: Maximal inspiratory pressure Time: Post breathing exercise sessions (up to 4 weeks)Description: Histology will be used to determine fiber type and cross-sectional area using primary antibodies for laminin and type-specific myosin heavy chain, followed by a triple immunofluorescence-conjugated secondary antibody labeling technique.
Measure: Muscle fiber cross-sectional area and fiber type proportion. Time: Intra-operativelyDescription: Spirometry will be used to measure peak expiratory flow during a voluntary cough maneuver. It will be quantified in liters per second.
Measure: Peak expiratory flow Time: Post breathing exercise sessions (up to 4 weeks)Description: Time to extubation will be measured as hours of post-operative mechanical ventilation.
Measure: Time to extubation Time: Up to discharge from ICUDescription: Length of ICU stay will be measured as hours spent in ICU after surgery.
Measure: Length of ICU stay Time: Up to 1 monthDescription: Length of hospital stay will be measured as hours spent in hospital after surgery.
Measure: Length of hospital stay Time: Up to 1 monthDescription: Histology will be used to assess neuromuscular junction number and morphology using immunofluorescent-labeled antibodies for synaptophysin and alpha bungarotoxin. Neuromuscular junction image stacks will be visualized with confocal microscopy and morphology classified according to endplate area and area fractions of fragmented junctions, acetylcholine receptor-occupied endplate area, synaptophysin-occupied endplates, and abandoned endplates.
Measure: Neuromuscular junction morphology Time: Intra-operativelyDescription: RNA isolation will be performed using Tri Reagent and chloroform based manual method. RNA will be quantified and RNA-Seq will be used to assess gene expression.
Measure: Muscle differential gene expression Time: Intra-operativelyDescription: Physical function will be assessed with the Patient Reported Outcomes Measurement Information System Physical Function questionnaire. Each answer corresponds to a number between 1 and 5.
Measure: Physical Function Time: Post breathing exercise sessions (up to 4 weeks)Description: Dyspnoea will be assessed with the Dyspnoea 12 Questionnaire. Responses range from None to Severe.
Measure: Dyspnoea Time: Post breathing exercise sessions (up to 4 weeks)This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic.
Description: Feasibility will be defined as recruitment of 50 participants to the study within 2 months.
Measure: Study recruitment Time: Within 2 monthsDescription: Defined as more than 50% of participants perceive the intervention as useful.
Measure: Acceptability of study Time: Up to 2 yearsDescription: Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).
Measure: Adherence to the practice Time: Up to 28 daysDescription: Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
Measure: Change in resilience Time: Day 0 to 28Description: Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
Measure: Perceive stress and psychological impact Time: Day 0 to 28Description: Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
Measure: Breath holding time Time: Up to 28 daysPreliminary reports have been received from several sources that the periodic inhaling of water with a heightened level of kinetic activity has lessened the severity of symptoms in Covid-19 infected patients. On at least several occasions, a repeat PCR test performed two days after inhaling a particular water-based product was negative. There are no perceived advese effects from inhaling the water using a nebulizer or humidifier. It is important, however, to validate these preliminary findings and to include other similar products in the testing
Description: Proportion of the Covid-19 PCR or Antigen Positive Participants Who Subsequently Test Negative Using the Same Assay Procedure
Measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals Time: Two days of inhalation prior to the repeat Covid-19testingDescription: Proportion of the Symptomatic Participants Who Become Asymptomatic
Measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals Time: Symptoms prior to and after two days of inhalationRationale: This protocol describes a study on the local tolerability of dry powder hydroxychloroquine using the Cyclops in healthy volunteers. Objective: - Primary objective is to assess the local tolerability of dry powder hydroxychloroquine sulphate via the Cyclops at different dosages. - Secondary objective is to investigate systemic pharmacokinetic parameters of dry powder hydroxychloroquine sulphate via the Cyclops at different dosages. Study design: single center, ascending dose study Study population: twelve healthy volunteers Main study parameters/endpoints: The local tolerability of the inhalation of dry powder hydroxychloroquine sulphate (5, 10 and 20 mg) defined by a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%), cough, or any other reported adverse event. Pharmacokinetic parameters will be derived from calculated actual inhaled dose (dose minus remainder in inhaler after inhalation) and in blood samples drawn pre-dose, at 0.5 and 2 and 3.5 hrs after inhalation. The inspiratory parameters during the inhalation maneuver are critical to explore predictors for drug exposure. The following parameters will be measured/calculated: dPmax (maximum pressure drop), Vi (inhaled volume), Ti (total inhalation time), PIF (peak inspiratory flow rate), MIF (mean inspiratory flow rate) and the FIR (average flow increase rate between 20% and 80% of PIF). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants included are healthy volunteers. They will receive three different doses of hydroxychloroquine sulphate using the dry powder inhaler (DPI) with (at least) seven days in between doses. Before using the dry powder inhaler (DPI), they will receive instructions and their inspiratory flow will be tested. To investigate local tolerability, lung function tests will be performed, and the occurrence of adverse events will be scored. Furthermore, before each test dose an indwelling cannula will be inserted and blood samples will be taken before and after each test dose. Four blood samples will be collected with each inhaled dose. Finally, five ECGs will be obtained to monitor for QT prolongation, one at the screenings visit, one at base-line and one after each inhalation.
Description: Number of patients with a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%.
Measure: Local tolerability Time: 35 minutes after inhalationDescription: Number of patients with a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%.
Measure: Local tolerability Time: 95 minutes after inhalationDescription: Number of patients that report cough, or any other adverse event after inhalation.
Measure: Local tolerability Time: 5 hoursDescription: Calculated actual inhaled dose
Measure: Pharmacokinetic parameter Time: 0,5 hourDescription: Cmax
Measure: Pharmacokinetic parameter Time: 3,5 hoursDescription: Tmax
Measure: Pharmacokinetic parameter Time: 3,5 hoursThe primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).
Description: Time-weighted Average Change in SARS-CoV-2 viral load is defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7
Measure: Time-weighted Average Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7 Time: Baseline, Day 7Description: AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: AUClast is defined as the concentration of drug from time zero to the last observable concentration. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: AUClast of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: CLss/F is defined as apparent oral clearance at steady state after administration of the drug. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: CLss/F of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: t1/2 of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Vz/F is defined as the apparent volume of distribution of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Vz/F of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Cmax is defined as the maximum observed concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Cmax of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Tmax is defined as the time (observed time point) of Cmax. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Tmax of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Clast is defined as the last observable concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Clast of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Tlast is defined as the time (observed time point) of Clast. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Tlast of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: AUCtau of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: λz of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Description: Ctau is defined as the observed drug concentration at the end of the dosing interval. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Measure: PK Parameter: Ctau of RDV and its Metabolites (GS-441524 and GS-704277) Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.Since ARDS is a major complication of COVID - 19 with subsequent formation of non-cardiogenic pulmonary edema , worsening the oxygenation of the patients and foamy and even bloody sputum formation, so the idea is to use alcohol inhalation as it reduce surface tension on the alveoli and markedly decrease sputum formation with improvement on oxygenation beside its cytolethal effect on virus lipid bilayer. A lot of researches and publications proved the role of alcohol inhalation in treatment of pulmonary edema. Alcohol inhalation may has inflammatory effect and dangerous effect on patients but this can be controlled by the actual concentration used and the way we use it according to general condition of the patient and with the help of anti - inflammatory action of Asprin .
Description: Destruction of COVID-19 in human respiratory tract and treatment of the patients with COVID 19 and Negative PCR test .
Measure: Disinfection of COVID-19 in human respiratory tract . Time: Negative PCR test within 7 days from starting the protocol .Description: Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .
Measure: Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive .. Time: Negative PCR test within 10 days from starting the protocol .This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
Description: AE frequency in each cohort and treatment group
Measure: Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency Time: Up to Day 6Description: Maximum concentration of active drug molecules in blood (Cmax)
Measure: Pharmacokinetic Parameters: Cmax Time: Up to Day 4 of participant treatmentDescription: Time to reach maximum level (Tmax)
Measure: Pharmacokinetic Parameters: Tmax Time: Up to Day 4 of participant treatmentDescription: Area Under the Curve of drug level in blood versus time (AUC)
Measure: Pharmacokinetic Parameters: AUC Time: Up to Day 4 of participant treatmentDescription: Half life
Measure: Pharmacokinetic Parameters: Half life Time: Up to Day 4 of participant treatmentThis is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.
Description: AEs and SAEs will be collected.
Measure: Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: AEs and SAEs will be collected.
Measure: Part B: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 18Description: AEs and SAEs will be collected.
Measure: Part C: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of hematology laboratory (lab) parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part B: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part B: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part B: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part C: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part C: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part C: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part A: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part B: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 18Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part C: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 8Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT intervals (QTc). The QT interval will be corrected for heart rate by Fredericia's formula (QTcF).
Measure: Part A: Number of participants with clinically significant abnormalities in 12-Lead electrocardiogram (ECG) findings Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part B: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 18Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part C: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 8Description: Spirometry measurements including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be assessed
Measure: Part A: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part B: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 18Description: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part C: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to last quantifiable concentration (AUC[0-t]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentration of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to infinity (AUC[0-inf]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Maximum observed GSK3923868 plasma concentration (Cmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Time to maximum observed plasma drug concentration (Tmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: AUC from time 0 (predose) to time tau (AUC [0-tau]) (tau=24hours for once a day dosing regimen) of GSK3923868 on Day 1 and Day 14 Time: Day 1 and 14: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Cmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Tmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: AUC (0-tau) (tau=24hours for once a day dosing regimen)of GSK3923868 on Day 1 and Day 7 Time: Day 1 and 7: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Cmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Tmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.
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: Health- related quality of life Time: change from baseline in EQ-5D score at 8 weeks and 6 monthsDescription: Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.
Measure: Peak VO2 Time: change from baseline in Peak VO2 at 8 weeks and 6 monthsDescription: The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.
Measure: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) Time: change from baseline in VE/VCO2 Slope at 8 weeks and 6 monthsDescription: The modified Medical Research Council Dyspnea Scale (mMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.
Measure: Dyspnea Time: change from baseline in mMRC score at 8 weeks and 6 monthsDescription: Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements
Measure: Respiratory muscle strength Time: change from baseline in MIP and MEP at 8 weeks and 6 monthsDescription: Six minute walking test ia a field test designed to measure exercise capacity
Measure: Exercise Capacity Time: change from baseline in distance during Six minute walking test at 8 weeks and 6 monthsDescription: Fatigue severity scale (FSS) is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome
Measure: severity of fatigue Time: change from baseline in FSS score at 8 weeks and 6 monthsDescription: Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale.
Measure: Anxiety and Depression Time: Change from baseline in HADS score at 8 weeks and 6 monthsDescription: Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
Measure: incremental cost-utility ratio Time: 6 monthsThe 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
Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Measure: incidence of Serious Adverse Events Time: 30 daysDescription: Time to fever resolution
Measure: fever resolution Time: Baseline to 30 daysDescription: Number of patients requiring admission to ICU
Measure: ICU admission Time: Baseline to 30 daysDescription: Time until patient no longer requires supportive oxygen
Measure: Oxygen support Time: Baseline to 30 daysDescription: 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 daysThis is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a lead-in cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 (separate inhalers or combination product) and medium dose ICS-LABA as a combination product for Part 2 at Screening. Part 2 will be initiated for each dose level following evaluation of safety and PK at the relevant dose level in Part 1. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.
Description: To evaluate the safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA. Safety and tolerability variables included AEs/ adverse events of special interest (AESIs) / serious adverse events (SAEs), vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, Electrocardiograms (ECGs), Forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO).
Measure: Part 1: Number of participants with adverse events (AEs) Time: From Day 1 until Follow-up (Day 56 ± 4)Description: To investigate the efficacy of inhaled AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4 Time: Baseline and Week 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Maximum observed serum (peak) drug concentration (Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Time to reach peak or maximum observed concentration or response following drug administration (tmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Observed lowest drug concentration reached before the next dose is administered (pre-dose) (Ctrough) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under plasma concentration-time curve in the dosing interval (AUCτ) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under the plasma concentration time curve in the dosing interval τ divided by the dose administered (Dose normalised AUCτ) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Time of last observed (quantifiable) concentration (tlast) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Accumulation ratio for AUCτ (Rac AUC) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Accumulation ratio for Cmax (Rac Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the immunogenicity of AZD1402.
Measure: Part 1 and Part 2: Antidrug antibodies (ADA) titers testing for all ADA-positive samples as measure of immunogenicity Time: Day 1 until Day 56 ± 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in pre bronchodilator FEV1 average over the 4-week Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in post bronchodilator FEV1 average over the 4-week Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measure: Part 2: Change from baseline in Asthma control questionnaire-6 (ACQ-6) at Week 4 and average over the Treatment Period Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measure: Part 2: Proportion of participants with a decrease in ACQ 6 score of ≥ 0.5 from baseline to Week 4 Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in asthmatics who are uncontrolled on medium dose ICS-LABA. The SGRQ is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Measure: Part 2: Change from baseline in St. George's respiratory questionnaire (SGRQ) score to Week 4 Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.
Measure: Part 2: Change from baseline in average morning Peak expiratory flow (PEF) over the Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.
Measure: Part 2: Change from baseline in average evening PEF over the Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Severity scores for asthma symptoms will be recorded twice daily in the morning and evening and documented in the e-Diary. Asthma symptom scores during night-time and day-time will be assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. You are aware of your asthma symptoms but you can easily tolerate the symptoms. Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome.
Measure: Part 2: Change from baseline in daily average asthma symptom score (AM/PM) over the Treatment Period Time: Baseline, 4 weeksDescription: To investigate the effect of AZD1402 compared to placebo on airway inflammation in adults with asthma who are uncontrolled on medium dose ICS-LABA. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO will be performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation will be followed such that plateau definition can be evaluated over a minimum of 3 seconds. The concentration of FeNO will be measured in units of part per billion (ppb).
Measure: Part 2: Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 4 and average over the Treatment Period Time: Baseline, Week 4Description: To evaluate the safety and tolerability of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Safety and tolerability variables included AEs/AESIs/SAEs, vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, ECGs, FEV1 and FeNO.
Measure: Part 2: Number of participants with adverse events (AEs) Time: From Day 1 until the Follow-up (Day 56 ± 4)The huge impact of the COVID-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR), heart rate variability (HRV), oxyhemoglobin saturation (SpO2), and body mass index (BMI) from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. This study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.
Description: Blood pressure will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measure: Vital signs measurement Time: 24 hoursDescription: Heart rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measure: Vital signs measurement Time: 24 hoursDescription: Breathing rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measure: Vital signs measurement Time: 24 hoursDescription: Heart rate variability will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measure: Vital signs measurement Time: 24 hoursDescription: Oxygen saturation will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measure: Vital signs measurement Time: 24 hoursDescription: Body mass index (BMI: height and weight) by using Anura app and medical grade standard device
Measure: Body mass index Time: 24 hoursFor spontaneous breathing patients with tracheostomy, whose lower airway is directly opened to the room air, the aerosol particles generated by the patients would be directly dispersed into the room air, which might be an direct resource of virus transmission. However, the transmission risk has not been evaluated and the appropriate humidification therapy is unknown. Thus this study is aimed to investigate the aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.
Description: aerosol particle concentrations at 1 foot away from patient
Measure: aerosol particle concentrations at 1 foot away from patient Time: 5 minutes after using the deviceDescription: aerosol particle concentrations at 3 feet away from patient
Measure: aerosol particle concentrations at 3 feet away from patient Time: 5 minutes after using the deviceDescription: patients would scale their comfort at a 5-point Likert scale
Measure: patient comfort with different oxygen devices Time: 5 minutes after using the deviceAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports