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low enrollment
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Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUR-928 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUR-928 | Drug | IV infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint of Alive and Free of Organ Failure at Day 28 | Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Alive at Days 28 and 60 | Day 28 and Day 60 | |
| Alive, Out of ICU, at Day 28 | Day 28 | |
| Alive, Out of Hospital, at Days 28 and 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gordon, MD | CTI Clinical Trial and Consulting Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 03 | Newark | New Jersey | 07103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DUR-928 | DUR-928: IV infusion |
| FG001 | Placebo | Placebo: IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated early due to lack of enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | DUR-928 | DUR-928: IV infusion |
| BG001 | Placebo | Placebo: IV infusion |
| BG002 |
| 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 | Composite Endpoint of Alive and Free of Organ Failure at Day 28 | Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure | Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively). | Posted | Count of Participants | Participants | Day 28 |
|
60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
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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 | DUR-928 | DUR-928: IV infusion | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | ACUTE HYPOXIC RESPIRATORY FAILURE 2/2 COVID PNA 2/2 TERMINAL EXTUBATION |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Early study termination led to small number (n=2) of subjects and in one treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Regulatory Affairs | DURECT Corporation | 408-777-1417 | jill.burns@durect.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2020 | Jul 12, 2022 | Prot_SAP_001.pdf |
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3:1 randomization DUR-928:placebo
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| Drug |
IV infusion |
|
| Day 28 and Day 60 |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Alive at Days 28 and 60 | Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively). | Posted | Count of Participants | Participants | Day 28 and Day 60 |
|
|
|
| Secondary | Alive, Out of ICU, at Day 28 | Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively). | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | Alive, Out of Hospital, at Days 28 and 60 | Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively). | Posted | Count of Participants | Participants | Day 28 and Day 60 |
|
|
|
| 2 |
| 2 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | Placebo: IV infusion | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Brain Injury | Nervous system disorders | Systematic Assessment | ANOXIC BRAIN INJURY SECONDARY TO CEREBRAL EDEMA AND SAH |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Activated Partial Thromboplastin Time Prolonged | Investigations | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
The disclosure restriction on the PI is that if sponsor has not submitted a multi-site publication within 18 months of study completion, the PI can submit the sponsor results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI will remove confidential information from results communications prior to publication upon request.