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 (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug691 | Melphalan Wiki | 0.50 |
| drug758 | Nitric Oxide delivered via LungFit system Wiki | 0.50 |
| drug817 | PSG Wiki | 0.50 |
| drug820 | PUL-042 Inhalation Solution Wiki | 0.35 |
| drug1067 | Standard of care Wiki | 0.15 |
| drug850 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012120 | Respiration Disorders NIH | 0.19 |
| D012140 | Respiratory Tract Diseases NIH | 0.16 |
| D011024 | Pneumonia, Viral NIH | 0.14 |
| D011014 | Pneumonia NIH | 0.07 |
| D007239 | Infection NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
There are 4 clinical trials
Clinical Trials
1 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 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 days2 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 inclusion3 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
4 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
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 28The 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
need for high flow nasal cannula (HFNC) or
need for intubation
Measure: Time to deterioration Time: 14 Days
Secondary Outcomes
Description: Time to non-invasive ventilation
Measure: Time to non-invasive ventilation Time: 14 Days
Description: Time to HFNC
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) greater than 92%
Measure: Time to patient having stable oxygen saturation (SpO2) greater than 92% 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
HPO Nodes
Primary Outcomes
Description: Time to deterioration measured by need for NIV, HFNC or intubation need for high flow nasal cannula (HFNC) or need for intubation
Measure: Time to deterioration Time: 14 DaysSecondary Outcomes
Description: Time to non-invasive ventilation
Measure: Time to non-invasive ventilation Time: 14 DaysDescription: Time to HFNC
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) greater than 92%
Measure: Time to patient having stable oxygen saturation (SpO2) greater than 92% 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 days