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D053120: Respiratory Aspiration

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 (23)


Name (Synonyms) Correlation
drug1222 Ethanol with Asprin Wiki 0.29
drug573 Buspirone + PAP therapy Wiki 0.29
drug2639 Prescription Opioid Management App Wiki 0.29
Name (Synonyms) Correlation
drug1774 KELEA Excellerated Water Wiki 0.29
drug1997 Meditation Therapy Wiki 0.29
drug2406 PSG Wiki 0.29
drug3703 Water Without an Elevated Level of KELEA Wiki 0.29
drug1989 Media Intervention Wiki 0.29
drug1678 Inspiratory Muscle Training Wiki 0.29
drug2856 Remdesivir (RDV) Wiki 0.29
drug3759 Zolpidem + PAP therapy Wiki 0.29
drug2203 Nitric Oxide delivered via LungFit™ system Wiki 0.29
drug3925 inhaled hydroxychloroquine Wiki 0.29
drug2008 Melphalan Wiki 0.29
drug162 Acetazolamide + supplemental oxygen + PAP therapy Wiki 0.29
drug2852 Relaxation Breathing Wiki 0.29
drug2414 PUL-042 Inhalation Solution Wiki 0.20
drug3743 Yoga Wiki 0.14
drug2731 Quality-of-Life Assessment Wiki 0.14
drug2200 Nitric Oxide Wiki 0.14
drug2742 Questionnaire Administration Wiki 0.11
drug3231 Standard of care Wiki 0.06
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D020182 Sleep Apnea, Central NIH 0.29
D012891 Sleep Apnea, NIH 0.14
D012120 Respiration Disorders NIH 0.07
Name (Synonyms) Correlation
D011024 Pneumonia, Viral NIH 0.07
D012140 Respiratory Tract Diseases NIH 0.06
D011014 Pneumonia NIH 0.03
D007239 Infection NIH 0.01
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0002871 Central apnea HPO 0.29
HP:0010535 Sleep apnea HPO 0.14
HP:0002090 Pneumonia HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 12 clinical trials


1 Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment

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.

NCT04118387
Conditions
  1. Sleep Disordered Breathing
  2. Able Bodied
Interventions
  1. Drug: Acetazolamide + supplemental oxygen + PAP therapy
  2. Drug: Zolpidem + PAP therapy
  3. Drug: Buspirone + PAP therapy
MeSH:Sleep Apnea Syndromes Respiratory Aspiration Sleep Apnea, Central
HPO:Central apnea Central sleep apnea Sleep apnea

Primary Outcomes

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 days

Description: Central apnea indices is used to indicate the severity of central sleep apnea

Measure: Central apnea indices

Time: 120 days

Secondary Outcomes

Description: Controller gain is a ventilatory response to changes in end-tidal PCO2

Measure: Controller gain

Time: 120 days

Description: 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 days

Description: 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 days

Description: Peripheral chemoreflex sensitivity is measured either via brief hypoxia or a single breath of CO2.

Measure: Peripheral chemoreflex sensitivity

Time: 120 days

Description: The nadir pressure in the upper airway (supra-glottic pressure) prior to the occurrence of an arousal.

Measure: Respiratory arousal threshold

Time: 120 days

Description: 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 days
2 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Adults 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

NCT04312997
Conditions
  1. COVID-19
Interventions
  1. Drug: PUL-042 Inhalation Solution
  2. Drug: Placebo
MeSH:Infection Respiratory Aspiration

Primary Outcomes

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 days

Secondary Outcomes

Description: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy

Measure: SARS-CoV-2 infection

Time: 28 days

Description: 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 days

Description: 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 days

Description: The requirement for ICU admission within 28 days from the start of the experimental therapy.

Measure: ICU admission

Time: 28 days

Description: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.

Measure: Mechanical Ventilation

Time: 28 days

Description: All cause mortality at 28 days from the start of experimental therapy

Measure: Mortality

Time: 28 days
3 Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS

Most 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).

NCT04371029
Conditions
  1. ARDS
  2. COVID-19
Interventions
  1. Other: PSG
MeSH:Respiratory Aspiration

Primary Outcomes

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 inclusion

Secondary Outcomes

Description: 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 inclusion

Description: 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 discharge

Description: 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 discharge

Description: Thanks to a PSG at 3 months, the seep architecture will be estimated.

Measure: Sleep architecture at month-3

Time: 3 months after hospital discharge

Description: all cost will be estimated during ICU hospitalization.

Measure: Cost of ICU hospitalization

Time: From inclusion to ICU discharge, up to 10 days after inclusion
4 Single-center, Prospective, Open-label, Comparator Study, Blind for Central Accessor to Access the Efficacy, Safety, and Tolerability of Inhalations of Low-doses of Melphalan in Patients With Pneumonia With Confirmed or Suspected COVID-19

This 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.

NCT04380376
Conditions
  1. COVID-19
  2. Viral Pneumonia
Interventions
  1. Drug: Melphalan
  2. Other: Standard of care
MeSH:Pneumonia, Viral Pneumonia Respiratory Aspiration
HPO:Pneumonia

Primary Outcomes

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 28

Description: 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 28

Description: 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 28

Secondary Outcomes

Description: 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 28

Description: 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 28

Description: 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 28

Description: 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 28

Description: 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 28
5 Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide.

This 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.

NCT04388683
Conditions
  1. COVID-19
Interventions
  1. Drug: Nitric Oxide
MeSH:Respiratory Aspiration

Primary Outcomes

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 days

Secondary Outcomes

Measure: Prevention of progression assessed by an alternate severity scale

Time: 28 days

Measure: Time to reaching maximal severity score

Time: 28 days

Measure: Proportion of patients in each stage at maximum severity

Time: 28 days

Measure: PaO2/FIO2 or SaO2/FIO2 ratio, measured daily

Time: 28 days

Measure: Length of hospital Stay (death assigned as worst case)

Time: 28 days

Measure: Frequency of Intubation, ECMO, or need to intubate with "Do Not Resuscitate" order

Time: 28 days

Measure: Mortality

Time: 28 days

Measure: IL6 level

Time: 7 days

Measure: TNF-alpha level

Time: 7 days

Measure: Fibrinogen level

Time: 7 days

Measure: CRP level

Time: 7 days

Measure: Ferritin Level

Time: 7 days

Measure: D-dimer level

Time: 7 days
6 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 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
7 Telehealth-Delivered Preoperative Inspiratory Muscle Training: An Innovative Solution to Conserve Scarce ICU Resources

In 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.

NCT04423614
Conditions
  1. Mechanical Ventilation Complication
Interventions
  1. Other: Inspiratory Muscle Training
  2. Other: Relaxation Breathing
MeSH:Respiratory Aspiration

Primary Outcomes

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-operatively

Secondary Outcomes

Description: 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 ICU

Description: Length of ICU stay will be measured as hours spent in ICU after surgery.

Measure: Length of ICU stay

Time: Up to 1 month

Description: Length of hospital stay will be measured as hours spent in hospital after surgery.

Measure: Length of hospital stay

Time: Up to 1 month

Description: 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-operatively

Description: 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-operatively

Description: 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)
8 Breathing Techniques and Meditation for Health Care Workers During COVID-19

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.

NCT04482647
Conditions
  1. COVID-19 Infection
Interventions
  1. Other: Media Intervention
  2. Procedure: Meditation Therapy
  3. Other: Quality-of-Life Assessment
  4. Other: Questionnaire Administration
  5. Procedure: Yoga
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Feasibility will be defined as recruitment of 50 participants to the study within 2 months.

Measure: Study recruitment

Time: Within 2 months

Description: Defined as more than 50% of participants perceive the intervention as useful.

Measure: Acceptability of study

Time: Up to 2 years

Secondary Outcomes

Description: 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 days

Description: Measured by the Brief Resilient Coping Scale among health care workers questionnaire.

Measure: Change in resilience

Time: Day 0 to 28

Description: 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 28

Description: 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 days
9 Can Inhalation of KELEA Excellerated Water Reduce the Time Required for Covid-19 Infected Individuals to Become Symptom-Free and to Test Negative Using Either the PCR or Antigen Assay

Preliminary 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

NCT04490824
Conditions
  1. Covid19
Interventions
  1. Device: KELEA Excellerated Water
  2. Device: Water Without an Elevated Level of KELEA
MeSH:Respiratory Aspiration

Primary Outcomes

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-19testing

Secondary Outcomes

Description: 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 inhalation
10 Local Tolerability and Pharmacokinetic Evaluation of Cyclops Dry Powder Hydroxychloroquine Inhalation in Healthy Volunteers; a Pilot Study

Rationale: 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.

NCT04497519
Conditions
  1. Covid19
Interventions
  1. Drug: inhaled hydroxychloroquine
MeSH:Respiratory Aspiration

Primary Outcomes

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 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: 95 minutes after inhalation

Description: Number of patients that report cough, or any other adverse event after inhalation.

Measure: Local tolerability

Time: 5 hours

Secondary Outcomes

Description: Calculated actual inhaled dose

Measure: Pharmacokinetic parameter

Time: 0,5 hour

Description: Cmax

Measure: Pharmacokinetic parameter

Time: 3,5 hours

Description: Tmax

Measure: Pharmacokinetic parameter

Time: 3,5 hours
11 A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

The 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).

NCT04539262
Conditions
  1. COVID-19
Interventions
  1. Drug: Remdesivir (RDV)
  2. Drug: Placebo
MeSH:Respiratory Aspiration

Primary Outcomes

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 7

Secondary Outcomes

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

Time: First dose date up to 5 days plus 30 days

Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities

Time: First dose date up to 5 days plus 30 days

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation

Time: First dose date up to 5 days plus 30 days

Measure: Proportion of Participants Progressing From Early Stage Coronavirus Disease 2019 (COVID-19) to Hospitalization or Death by Day 14

Time: Day 14

Description: 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.

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 4

Time: Baseline, Day 4

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 7

Time: Baseline, Day 7

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 14

Time: Baseline, Day 14

Measure: Time to Negative SARS-CoV-2 Polymerase Chain Reaction (PCR)

Time: First dose date up to 14 days
12 Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .

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 .

NCT04554433
Conditions
  1. Covid-19
  2. Drug Effect
Interventions
  1. Drug: Ethanol with Asprin
MeSH:Respiratory Aspiration

Primary Outcomes

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 .

Secondary Outcomes

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 .

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