Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GX-03 · 2 trials · 4 indications
vIGA-AD score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 8
Time to achieve a 60% reduction in viral load from baseline.
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
| Arm | Type | Description |
|---|---|---|
| GX-03 | EXPERIMENTAL | Treatment Arm |
| Vehicle | EXPERIMENTAL | Vehicle Control |
| Treatment of hospitalized patients with laboratory-confirmed COVID-19 | EXPERIMENTAL | Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days. |
| Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19 | PLACEBO_COMPARATOR | Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days. |
| Prevention of SARS-COV-2 in Health Care Providers | EXPERIMENTAL | Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days. |
| Placebo Prevention of SARS-COV-2 in Health Care Providers | PLACEBO_COMPARATOR | Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days. |
| Name | Type | Description |
|---|---|---|
| GX-03 | COMBINATION_PRODUCT | Topical ointment |
| Vehicle | OTHER | Ointment carrier |
| Petrolatum ointment | DRUG | Viscous ointment similar in form to study drug. |
Participants must meet all of the following criteria: * Adults aged 18 to 80 years, inclusive * Male or female subjects in good general health as determined by medical history * Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by: * Ec...