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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04834856 | Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients | PHASE2 | COMPLETED | 12 | — | — | Apr 1, 2021 | Aug 20, 2021 | Sep 8, 2021 | 1 | Netherlands |
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs
Duration in days to SARS-CoV-2 PCR negativity
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
| Arm | Type | Description |
|---|---|---|
| ensovibep dose 1 | EXPERIMENTAL | - |
| ensovibep dose 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ensovibep | DRUG | The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion. |
Inclusion Criteria: * Men or non-pregnant women, between 18 and 70 years on the day of inclusion. * Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. * Posi...