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The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.
This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone in hospitalized patients with COVID-19 (World Health Organization [WHO] ordinal scale level 3 or 4).
Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care. |
|
| Control arm | Active Comparator | Participants will receive institutional SOC for the treatment of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESP301, a Nitric Oxide generating solution | Drug | Product application requires inhalation using a standard handheld nebulizer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale | A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. The number of participants that had an increase in at least one level higher score on the modified WHO ordinal scale was assessed. | Baseline, Day 2 and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time | Pulse oximetry measurements were performed to evaluate SpO2. The effect of RESP301 as measured by room air SpO2 was assessed. | Day 1 (Baseline) Post-Nebulization, Day 2, 3, 4, 5, 6, and 7 |
| Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust, St. Mary's Hospital | London | W2 1NY | United Kingdom | |||
| Royal Preston Hospital |
The screening period was of 2 days. All the study assessments were performed as per the schedule of assessment.
The study was conducted at 2 centers that enrolled 19 participants in the United Kingdom (UK) from 29-Jul-2020 (First Enrolment) to 21-May-2021 (Last Participant Completed).
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| ID | Title | Description |
|---|---|---|
| FG000 | RESP301+SoC | Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC). |
| FG001 | Standard of Care (SoC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2020 | Apr 7, 2022 |
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| Standard of Care | Other | Participants will receive institutional SOC for the treatment of COVID-19. |
|
The NEWS is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to, or are being monitored in hospital. Six simple physiological parameters form the basis of the scoring system: 1. Respiration rate; 2. Oxygen saturation; 3. Systolic blood pressure; 4. Pulse rate; 5. Level of consciousness or new confusion; 6. Temperature. Each score is 0-3 and individual scores are added together for an overall score. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention, and more intensive monitoring. |
| Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7 |
| Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit | A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. Change from baseline for Number of Participants on the modified WHO ordinal scale was assesed. | Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7 |
| Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale | Time to improvement is the time in which the participant sees a decrease after first study treatment in the WHO 7-point ordinal scale from baseline to a value at least one level lower in days (date of decrease in WHO scale - first dose date + 1). In the case that a patient has not decreased in the WHO scale at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | From Baseline to Day 28 |
| Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale | Time to progression is the time in which the patient sees an increase after first study treatment in the WHO 7-point ordinal scale from baseline to a value at least one level higher in days (date of increase in WHO scale - first dose date + 1). In the case that a patient has not increased in the WHO scale at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | From Baseline to Day 28 |
| Number of Participants With Adverse Events | AEs (non-serious) as variables of safety and tolerability of RESP301 were assessed. Severe AEs is defined as an event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event; and both AE and SAE can be assessed as severe. | From screening to safety follow up (Day 28) |
| Time to Hospital Discharge | Time to hospital discharge is the time in the hospital after first study treatment in days (date of discharge - first dose date + 1). Patients who die before leaving the hospital would be considered failures (did not achieve hospital discharge) and censored. In the case that a patient is still hospitalized at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | Day 10 |
| Number of Participants With Mortality by Day 28 | Incidence of mortality by Day 28 is the number of participants who have died by Day 28 and the percentage of patients reaching this endpoint will be summarized by treatment group. | Day 28 |
| Reduction in Oxygen Saturation (SpO2) to <90% | Room Air SpO2 for a summary of participants with reduction to < 90%, unless well clinically tolerated according to Investigator's opinion was assesed. | Day 1 (Baseline), Day 2, Day 3 |
| Events of Clinical Bronchial Hyper Responsiveness Related to Nebulization | Incidence of clinical bronchial hyper responsiveness related to nebulization was assessed. Oxygen saturation decreased and wheezing was assessed as an incidence of clinical bronchial hyper-responsiveness related to nebulization, requiring temporal increase of supplemental oxygen. | From screening to safety follow up (Day 28) |
| Preston |
| PR2 9HT |
| United Kingdom |
Participants received institutional SOC alone for the treatment of COVID-19.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RESP301+SoC | Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC). |
| BG001 | Standard of Care (SoC) | Participants received institutional SOC alone for the treatment of COVID-19. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale | A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. The number of participants that had an increase in at least one level higher score on the modified WHO ordinal scale was assessed. | The intent-to-treat (ITT) population included all randomized participants. For RESP301+SoC arm only 1 participant was available for this analysis who had an increase in at least one level higher score on the modified WHO ordinal scale. For SoC arm, no data were collected. Hence, 0 participants were analyzed. | Posted | Count of Participants | Participants | Baseline, Day 2 and Day 3 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time | Pulse oximetry measurements were performed to evaluate SpO2. The effect of RESP301 as measured by room air SpO2 was assessed. | The intent-to-treat (ITT) population included all randomized participants. Here, the number analyzed in each row signified only the participants that were analyzed for each timepoint. | Posted | Mean | Standard Deviation | Percent change | Day 1 (Baseline) Post-Nebulization, Day 2, 3, 4, 5, 6, and 7 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time | The NEWS is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to, or are being monitored in hospital. Six simple physiological parameters form the basis of the scoring system: 1. Respiration rate; 2. Oxygen saturation; 3. Systolic blood pressure; 4. Pulse rate; 5. Level of consciousness or new confusion; 6. Temperature. Each score is 0-3 and individual scores are added together for an overall score. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention, and more intensive monitoring. | The intent-to-treat (ITT) population included all randomized participants. Here, the number analyzed in each row signifies only the participants who were analyzed for each time point. | Posted | Mean | Standard Deviation | Score on a NEWS scale | Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit | A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. Change from baseline for Number of Participants on the modified WHO ordinal scale was assesed. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | No | Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale | Time to improvement is the time in which the participant sees a decrease after first study treatment in the WHO 7-point ordinal scale from baseline to a value at least one level lower in days (date of decrease in WHO scale - first dose date + 1). In the case that a patient has not decreased in the WHO scale at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | The intent-to-treat (ITT) population included all randomized participants. Here, the Overall Number of Participants Analyzed signified only the participants who decrease by at least one level. | Posted | Median | Full Range | Days | From Baseline to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale | Time to progression is the time in which the patient sees an increase after first study treatment in the WHO 7-point ordinal scale from baseline to a value at least one level higher in days (date of increase in WHO scale - first dose date + 1). In the case that a patient has not increased in the WHO scale at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | The intent-to-treat (ITT) population included all randomized participants. Here, the Overall Number of Participants Analyzed signified only the participants who increase by at least one level. | Posted | Median | Full Range | Days | From Baseline to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | AEs (non-serious) as variables of safety and tolerability of RESP301 were assessed. Severe AEs is defined as an event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event; and both AE and SAE can be assessed as severe. | The safety analysis set includes the safety (SP) population would include all randomized participants who inhale any amount of study intervention or were randomized to the control arm. The SP would be analyzed according to the actual treatment received. This set will be used for the safety analyses. | Posted | Count of Participants | Participants | From screening to safety follow up (Day 28) |
|
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| Secondary | Time to Hospital Discharge | Time to hospital discharge is the time in the hospital after first study treatment in days (date of discharge - first dose date + 1). Patients who die before leaving the hospital would be considered failures (did not achieve hospital discharge) and censored. In the case that a patient is still hospitalized at time of analysis or withdraws from the study before leaving the hospital, they would be censored at their date of last assessment in the data cut or early discontinuation date, respectively. | The intent-to-treat (ITT) population included all randomized participants. Here, the Overall Number of Participants Analyzed signified only the participants who were discharged from hospital. | Posted | Median | Full Range | Days | Day 10 |
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| Secondary | Number of Participants With Mortality by Day 28 | Incidence of mortality by Day 28 is the number of participants who have died by Day 28 and the percentage of patients reaching this endpoint will be summarized by treatment group. | The safety analysis set includes the safety (SP) population would include all randomized participants who inhale any amount of study intervention or were randomized to the control arm. The SP would be analyzed according to the actual treatment received. This set will be used for the safety analyses. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Reduction in Oxygen Saturation (SpO2) to <90% | Room Air SpO2 for a summary of participants with reduction to < 90%, unless well clinically tolerated according to Investigator's opinion was assesed. | The intent-to-treat (ITT) population included all randomized participants. Here, the number analyzed in each row signified only the participants that were analyzed for each time point. Standard of Care (SoC) participants did not receive any nebulization. Hence, no participants were analyzed for Pre-nebulization and Post-nebulization. Therefore, no data were available. | Posted | Mean | Standard Deviation | Percent change | Day 1 (Baseline), Day 2, Day 3 |
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| Secondary | Events of Clinical Bronchial Hyper Responsiveness Related to Nebulization | Incidence of clinical bronchial hyper responsiveness related to nebulization was assessed. Oxygen saturation decreased and wheezing was assessed as an incidence of clinical bronchial hyper-responsiveness related to nebulization, requiring temporal increase of supplemental oxygen. | The safety analysis set includes the safety (SP) population would include all randomized participants who inhale any amount of study intervention or were randomized to the control arm. The SP would be analyzed according to the actual treatment received. This set will be used for the safety analyses. | Posted | Number | Events | From screening to safety follow up (Day 28) |
|
|
From screening to safety follow up (30 days)
Severe AEs is defined as an event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event; and both AE and SAE can be assessed as severe.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RESP301+SoC | Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC). | 0 | 14 | 0 | 14 | 10 | 14 |
| EG001 | Standard of Care (SoC) Standard of Care (SoC) | Participants received institutional SOC alone for the treatment of COVID-19. | 0 | 5 | 0 | 5 | 2 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal Discomfort | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 23.0 | Non-systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | 23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | 23.0 | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | 23.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | 23.0 | Non-systematic Assessment |
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| Peripheral Swelling | General disorders | 23.0 | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | 23.0 | Non-systematic Assessment |
| |
| Liver Function Test Increased | Investigations | 23.0 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | 23.0 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | 23.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | 23.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | 23.0 | Non-systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | 23.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Bracchi, MSc | Thirty Respiratory Ltd | +447763882519 | alison.bracchi@30.technology |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2022 | Apr 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Baseline : WHO 7-point ordinal scale: 3 |
|
| Baseline : WHO 7-point ordinal scale: 4 |
|
| Baseline : WHO 7-point ordinal scale: 5 |
|
| Baseline : WHO 7-point ordinal scale: 6 |
|
| Baseline : WHO 7-point ordinal scale: 7 |
|
| Day 2 : WHO 7-point ordinal scale: 1 |
|
| Day 2 : WHO 7-point ordinal scale: 2 |
|
| Day 2 : WHO 7-point ordinal scale: 3 |
|
| Day 2 : WHO 7-point ordinal scale: 4 |
|
| Day 2 : WHO 7-point ordinal scale: 5 |
|
| Day 2 : WHO 7-point ordinal scale: 6 |
|
| Day 2 : WHO 7-point ordinal scale: 7 |
|
| Day 3 : WHO 7-point ordinal scale: 1 |
|
| Day 3 : WHO 7-point ordinal scale: 2 |
|
| Day 3 : WHO 7-point ordinal scale: 3 |
|
| Day 3 : WHO 7-point ordinal scale: 4 |
|
| Day 3 : WHO 7-point ordinal scale: 5 |
|
| Day 3 : WHO 7-point ordinal scale: 6 |
|
| Day 3 : WHO 7-point ordinal scale: 7 |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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