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Name (Synonyms) | Correlation | |
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drug1191 | Ethanol with Asprin Wiki | 0.28 |
drug1961 | Melphalan Wiki | 0.28 |
drug1871 | LungFit™ Wiki | 0.28 |
Name (Synonyms) | Correlation | |
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drug3472 | UNI911 INHALATION Wiki | 0.28 |
drug3597 | Water Without an Elevated Level of KELEA Wiki | 0.28 |
drug2783 | Remdesivir (RDV) Wiki | 0.28 |
drug1949 | Meditation Therapy Wiki | 0.28 |
drug3832 | inspiratory muscle traiing Wiki | 0.28 |
drug2162 | Nitric Oxide delivered via LungFit™ system Wiki | 0.28 |
drug1941 | Media Intervention Wiki | 0.28 |
drug2350 | PSG Wiki | 0.28 |
drug3082 | Sofosbuvir and Ledipasvir Wiki | 0.28 |
drug1727 | KELEA Excellerated Water Wiki | 0.28 |
drug3830 | inhaled hydroxychloroquine Wiki | 0.28 |
drug2797 | Repeat SARS-CoV-2 IgG antibodies at 45-65 days Wiki | 0.28 |
drug2358 | PUL-042 Inhalation Solution Wiki | 0.20 |
drug3632 | Yoga Wiki | 0.16 |
drug2159 | Nitric Oxide Wiki | 0.14 |
drug2672 | Quality-of-Life Assessment Wiki | 0.10 |
drug2687 | Questionnaire Administration Wiki | 0.08 |
drug2153 | Nitazoxanide Wiki | 0.07 |
drug3146 | Standard of care Wiki | 0.05 |
drug2448 | Placebo Wiki | 0.03 |
Navigate: Correlations HPO
There are 13 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 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 daysThis 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 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 daysAlphabetical 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