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Study was terminated early by Heron, and was not terminated for safety reasons.
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The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Aprepitant injectable emulsion. |
|
| Treatment Group 2 | Placebo Comparator | Saline placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant injectable emulsion | Drug | Aprepitant injectable emulsion, once daily (QD) for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Alive and Discharged From the Hospital. | ITT Population. | 14 Days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO). | 56 Days. | |
| Time to Discharge From Hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| University of California, Irvine Medical Center |
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One participant was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population', leading to a discrepancy between the Enrollment number in the Protocol Section (27) and the number of participants Started in the Participant Flow module (26).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1: Aprepitant Injectable Emulsion | Aprepitant injectable emulsion, 130 mg once daily (QD) for 14 days. |
| FG001 | Treatment Group 2: Placebo | Saline Placebo, QD for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group 1: Aprepitant Injectable Emulsion | Aprepitant injectable emulsion, 130 mg QD for 14 days. |
| BG001 | Treatment Group 2: Placebo | Saline Placebo, QD for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Proportion of Subjects Alive and Discharged From the Hospital. | ITT Population. | Posted | Count of Participants | Participants | 14 Days. |
|
|
Through Day 56.
One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
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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 | Treatment Group 1: Aprepitant Injectable Emulsion | Aprepitant injectable emulsion, 130 mg QD for 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Candida infection | Infections and infestations | MedDRA, Version 23.0 | Systematic Assessment |
Study was terminated early by Heron, and was not terminated for safety reasons. The data reported is only safety data generated from the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tricia Mulford | Heron Therapeutics, Inc. | 760-622-3709 | tmulford@herontx.com |
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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 | Dec 11, 2020 | Apr 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2021 | Apr 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Saline Placebo | Drug | Saline Placebo, once daily (QD) for 14 days. |
|
| 56 Days. |
| Change From Baseline in Interleukin 6 (IL-6). | Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo)) |
| Incidence of Treatment-emergent Adverse Events. | Number of subjects reporting at least on Treatment-Emergent Adverse Event. Subjects reporting more than one event are counted only once using the highest severity. | Through Day 56 |
| Orange |
| California |
| 92868 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO). | Posted | Median | 95% Confidence Interval | days | 56 Days. |
|
|
|
| Secondary | Time to Discharge From Hospital. | Posted | Median | 95% Confidence Interval | days | 56 Days. |
|
|
|
| Secondary | Change From Baseline in Interleukin 6 (IL-6). | Overall Number of Participants Analyzed reflects the Total Enrolled ITT Population whereas Number Analyzed in each row reflects the number of subjects with IL-6 data reported at the specified timepoint. | Posted | Mean | Standard Deviation | pg/mL | Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo)) |
|
|
|
| Secondary | Incidence of Treatment-emergent Adverse Events. | Number of subjects reporting at least on Treatment-Emergent Adverse Event. Subjects reporting more than one event are counted only once using the highest severity. | Posted | Count of Participants | Participants | Through Day 56 |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 8 |
| 12 |
| EG001 | Treatment Group 2: Placebo | Saline Placebo, QD for 14 days. | 1 | 14 | 2 | 13 | 5 | 13 |
| Sinus node dysfunction | Cardiac disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA, Version 23.0 | Systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Leuconostoc infection | Infections and infestations | MedDRA, Version 23.0 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Tongue discomfort | Gastrointestinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA, Version 23.0 | Systematic Assessment |
|
| Candida test positive | Investigations | MedDRA, Version 23.0 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA, Version 23.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA, Version 23.0 | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 7 |
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| Day 14 |
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| Day 28 |
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| Discharge |
|
|