Name (Synonyms) | Correlation | |
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drug594 | PSG Wiki | 0.71 |
drug597 | PUL-042 Inhalation Solution Wiki | 0.50 |
drug616 | Placebo Wiki | 0.07 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
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
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 severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Clinical Improvement within 10 days from the start of the experimental therapy.
Measure: Severity of COVID-19 Time: 10 daysDescription: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
Measure: SARS-CoV-2 infection Time: 28 daysDescription: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Clinical Improvement within 28 days from the start of the experimental therapy.
Measure: Severity of COVID-19 over 28 days 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 inclusion