Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04951349 | Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19. | PHASE2 | COMPLETED | 85 | — | — | Jan 21, 2021 | May 30, 2021 | Jul 6, 2021 | 3 | Panama |
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 |
|---|---|---|
| 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 | DRUG | Same dosage used in Bactroban Nasal studies. |
| Petrolatum ointment | DRUG | Viscous ointment similar in form to study drug. |
Inclusion Criteria: * 1\. Patients aged 18-65 hospitalized with SARS-CoV-2, diagnosed by a positive nasal or nasopharyngeal swab 2\. Men or women who are not pregnant, not breastfeeding, postmenopausal, naturally or surgically sterile, or who agree to use effective contraception during the cours...