Covid 19 Research using Clinical Trials (Home Page)
Report for D053120: Respiratory Aspiration NIH
(Synonyms: Respiratory As, Respiratory Aspirat, Respiratory Aspiration)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (20)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2410 | Relaxation Breathing Wiki | 0.32 |
| drug1878 | Nitric Oxide delivered via LungFit™ system Wiki | 0.32 |
| drug491 | Buspirone + PAP therapy Wiki | 0.32 |
| drug1701 | Media Intervention Wiki | 0.32 |
| drug3305 | inhaled hydroxychloroquine Wiki | 0.32 |
| drug1720 | Melphalan Wiki | 0.32 |
| drug3157 | Zolpidem + PAP therapy Wiki | 0.32 |
| drug138 | Acetazolamide + supplemental oxygen + PAP therapy Wiki | 0.32 |
| drug1517 | KELEA Excellerated Water Wiki | 0.32 |
| drug1709 | Meditation Therapy Wiki | 0.32 |
| drug2038 | PSG Wiki | 0.32 |
| drug2578 | Self-acupressure Wiki | 0.32 |
| drug1429 | Inspiratory Muscle Training Wiki | 0.32 |
| drug2045 | PUL-042 Inhalation Solution Wiki | 0.22 |
| drug3145 | Yoga Wiki | 0.18 |
| drug2302 | Quality-of-Life Assessment Wiki | 0.18 |
| drug1875 | Nitric Oxide Wiki | 0.16 |
| drug2312 | Questionnaire Administration Wiki | 0.12 |
| drug2707 | Standard of care Wiki | 0.07 |
| drug2122 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020182 | Sleep Apnea, Central NIH | 0.32 |
| D012891 | Sleep Apnea, NIH | 0.16 |
| D012120 | Respiration Disorders NIH | 0.08 |
| D011024 | Pneumonia, Viral NIH | 0.08 |
| D012140 | Respiratory Tract Diseases NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.04 |
| D007239 | Infection NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.01 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002871 | Central apnea HPO | 0.32 |
| HP:0010535 | Sleep apnea HPO | 0.16 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 10 clinical trials
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 Sleep Disordered Breathing Able Bodied Drug: Acetazolamide + supplemental oxygen + PAP therapy Drug: Zolpidem + PAP therapy 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
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 daysDescription: Central apnea indices is used to indicate the severity of central sleep apnea
Measure: Central apnea indices Time: 120 daysSecondary Outcomes
Description: 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
NCT04312997 COVID-19 Drug: PUL-042 Inhalation Solution 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 daysSecondary Outcomes
Description: 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 days3 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 ARDS COVID-19 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 inclusionSecondary 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 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 inclusion4 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 COVID-19 Viral Pneumonia Drug: Melphalan 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.
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 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 28Secondary 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 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.
NCT04388683 COVID-19 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 daysSecondary Outcomes
Measure: Prevention of progression assessed by an alternate severity scale Time: 28 daysMeasure: 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 Corona Virus Infection COVID-19 SARS-CoV 2 Nitric Oxide Respiratory Disease Pneumonia, Viral Inhaled Nitric Oxide 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
Primary Outcomes
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysSecondary Outcomes
Description: 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 daysOther Outcomes
Description: 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.
NCT04423614 Mechanical Ventilation Complication Other: Inspiratory Muscle Training 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-operativelySecondary 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 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)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 COVID-19 Infection Other: Media Intervention Procedure: Meditation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration 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 monthsDescription: Defined as more than 50% of participants perceive the intervention as useful.
Measure: Acceptability of study Time: Up to 2 yearsSecondary 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 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 daysOther Outcomes
Description: Will be assessed by self-reported spirometric evaluation measuring FEV1 and FVC.
Measure: Forced expiratory volume in 1 minute (FEV1) and forced vital capacity (FVC) Time: Up to 28 days9 Can Inhalation of KELEA Excellerated Water Reduce the Time Required for Covid-19 Infected Individuals to Become Symptom-Free and PCR Negative
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 Covid19 Device: KELEA Excellerated Water MeSH:Respiratory Aspiration
Primary Outcomes
Description: Proportion of the PCR Positive Participants Who Become PCR Negative
Measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals Time: Two days of inhalation prior to the repeat PCR testingSecondary 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 inhalation10 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 Covid19 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 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 hoursSecondary Outcomes
Description: 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 hours