Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 75A50123C00034 | Other Grant/Funding Number | ASPR-BARDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 0.025 | Experimental | Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours. |
|
| Cohort 0.032 | Experimental | Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours. |
|
| Cohort 0.050 | Experimental | Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dodecafluoropentane (0.025 mL/kg) | Drug | dodecafluoropentane (0.025 mL/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Cumulative incidence of adverse events and serious adverse events | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Rate Oxygenation (ROX) Index score | Change in ROX Index from baseline. ROX Index = 100*(SaO2/FiO2)/respiratory rate | 24 hours |
| World Health Organization (WHO) 8-point scale for clinical assessments |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NuvOx Pharma | Contact | 520-624-6688 | EXTEND_Clinical@nuvoxpharma.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grey Nun Community Hospital | Recruiting | Edmonton | Alberta | T6L 5X8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C008806 | perfluoropentane |
Not provided
Not provided
Not provided
Up to six subjects will be enrolled at each dose level
Not provided
Not provided
Not provided
Not provided
| dodecafluoropentane (0.032 mL/kg) | Drug | dodecafluoropentane (0.032 mL/kg) |
|
|
| dodecafluoropentane (0.050 mL/kg) | Drug | dodecafluoropentane (0.050 mL/kg) |
|
|
Evaluate distribution of WHO 8-point ordinal scale at various time points throughout the study. Clinical assessment assigning clinical status of increasing severity from 1 to 8.
| 28 days |
| NanO2 Oxygenation | Duration of NanO2 oxygenation response as measured by pulse oximetry | 2 days |
| Determine the effects of NanO2 on PaO2 measurements | Comparisons of PaO2 measurements before, during and after NanO2 infusions | 2 days |
| Hôpital Maisonneuve Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
|
| D013568 | Pathological Conditions, Signs and Symptoms |