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A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide (iNO) | Active Comparator | Pulsed inhaled iNO 125 mcg/kg IBW/hour |
|
| Placebo | Sham Comparator | Pulsed inhaled N2, 99.999% gas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INOpulse | Combination Product | Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Who Died or Had Respiratory Failure | The number of subjects who died or had respiratory failure through Day 28 | Through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects to Recover | Number of subjects to recover, where recover is defined as attaining a NIAID Ordinal score of 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen or 8) Not hospitalized, no limitations on activities sustained through Day 28, or discharge from hospital without re admission for COVID. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events Leading to Study Drug Discontinuation | Number of subjects with adverse events leading to study drug discontinuation through Day 28 | Through Day 28 |
Inclusion Criteria:
Signed informed consent
At least 18 years old
Subjects must be hospitalized and have the following:
Female subjects must have a negative pregnancy test
Willing and able to comply with the treatment schedule and study procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashika Ahmed, MD | Bellerophon Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Kaiser Permanente - Zion Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Nitric Oxide (iNO) | Pulsed inhaled iNO 125 mcg/kg IBW/hour INOpulse: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
| FG001 | Placebo |
| 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 | Aug 19, 2020 | May 26, 2022 |
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| Placebo | Combination Product | Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
|
| Through Day 28 |
| Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | Day 7 |
| Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | Day 14 |
| Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | Day 28 |
| Number of Subjects Discharged Alive From Hospital | Number of subjects discharged alive from hospital through Day 28 | Through Day 28 |
| Duration of Hospitalization | Duration of Hospitalization through Day 28 | Through Day 28 |
| All Cause Mortality | All cause mortality through Day 28 | Through Day 28 |
| Difference in Proportion in RT-PCR Results at Discharge by Treatment Group | Proportion of subjects with a positive RT-PCR result at baseline from a nasopharyngeal swab through Day 28 reported as a proportion of positive or negative RT-PCR testing. | Through Day 28 |
| San Diego |
| California |
| 92120 |
| United States |
| Kaiser Permanente - San Diego Medical Center | San Diego | California | 92123 | United States |
| University of Miami Health System | Miami | Florida | 33136 | United States |
| The Lung Research Center (St. Luke's) | Chesterfield | Missouri | 63017 | United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Mercy Health St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| INOVA | Falls Church | Virginia | 22042 | United States |
| St. Francis Medical Center | Richmond | Virginia | 23114 | United States |
| Memorial Regional Medical Center | Richmond | Virginia | 23116 | United States |
| Chippenham Medical Center | Richmond | Virginia | 23225 | United States |
| Pulmonary Associates of Richmond | Richmond | Virginia | 23226 | United States |
| St. Mary's Hospital | Richmond | Virginia | 23226 | United States |
| Johnston-Willis Hospital | Richmond | Virginia | 23235 | United States |
Pulsed inhaled N2, 99.999% gas
Placebo: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
| COMPLETED |
|
| NOT COMPLETED |
|
All Randomized Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide (iNO) | Pulsed inhaled iNO 125 mcg/kg IBW/hour INOpulse: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
| BG001 | Placebo | Pulsed inhaled N2, 99.999% gas Placebo: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
| 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, Categorical | 1 age value missing in Placebo group | Count of Participants | Participants | No |
| ||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | The Number of Subjects Who Died or Had Respiratory Failure | The number of subjects who died or had respiratory failure through Day 28 | All Randomized Analysis Set | Posted | Count of Participants | Participants | Through Day 28 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects to Recover | Number of subjects to recover, where recover is defined as attaining a NIAID Ordinal score of 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen or 8) Not hospitalized, no limitations on activities sustained through Day 28, or discharge from hospital without re admission for COVID. | Posted | Count of Participants | Participants | Through Day 28 |
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| Secondary | Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | All Randomized Analysis Set with NIAID scores at Day 7 | Posted | Least Squares Mean | Standard Error | score on a scale | Day 7 |
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| Secondary | Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | All Randomized Analysis Set with NIAID scores at Day 14 | Posted | Least Squares Mean | Standard Error | score on a scale | Day 14 |
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| Secondary | Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale | The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | All Randomized Analysis Set with NIAID scores at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Day 28 |
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| Secondary | Number of Subjects Discharged Alive From Hospital | Number of subjects discharged alive from hospital through Day 28 | (1) Discharged is defined as discharged alive from hospital through day 28. (2) For patients who were randomized but not treated, the date of randomization is used in place of the treatment start date. | Posted | Count of Participants | Participants | Through Day 28 |
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| Secondary | Duration of Hospitalization | Duration of Hospitalization through Day 28 | (1) Subject hospital duration will be defined as the time from Day 1 (start of study treatment) to the day of hospital discharge or Day 28 of treatment for patients who are still hospitalized. If a patient has expired on or before Day 27 of treatment, they will be assigned a value of 28 days. (2) For patients who were randomized but not treated, the date of randomization is used in place of the treatment start date. | Posted | Mean | Standard Deviation | Days | Through Day 28 |
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| Secondary | All Cause Mortality | All cause mortality through Day 28 | Posted | Count of Participants | Participants | Through Day 28 |
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| Secondary | Difference in Proportion in RT-PCR Results at Discharge by Treatment Group | Proportion of subjects with a positive RT-PCR result at baseline from a nasopharyngeal swab through Day 28 reported as a proportion of positive or negative RT-PCR testing. | Difference in converted RT-PCR Results at Discharge by Treatment Group. Only participants with a positive RT-PCR result at baseline are included in the analysis. | Posted | Number | 95% Confidence Interval | Proportion Converted | Through Day 28 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Adverse Events Leading to Study Drug Discontinuation | Number of subjects with adverse events leading to study drug discontinuation through Day 28 | Full Safety Set | Posted | Count of Participants | Participants | Through Day 28 |
|
|
Collected during the study duration that includes 14 days within randomization to 30 days post last day of treatment (up to 28 days of blinded treatment)
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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 | Inhaled Nitric Oxide (iNO) | Pulsed inhaled iNO 125 mcg/kg IBW/hour INOpulse: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. | 5 | 91 | 13 | 91 | 16 | 91 |
| EG001 | Placebo | Pulsed inhaled N2, 99.999% gas Placebo: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. | 1 | 95 | 12 | 95 | 28 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hemianopia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Plural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sputum discolored | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| SARS-CoV-2 sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Pruritus | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Visual impariment | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bobae Kim | Bellerophon Therapeutics | (917) 675-2254 | bobae.kim@bellerophon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2020 | May 26, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
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| Black or African American |
|
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| Asian |
|
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| America Indian or Alaska Native |
|
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| Native Hawaiian or Other Pacific Islander |
|
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| Other |
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|
Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level
| Odds Ratio (OR) |
| 1.502 |
| 2-Sided |
| 95 |
| 0.567 |
| 3.977 |
| Superiority |
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