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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000365-33 | EudraCT Number |
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This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ensovibep dose 1 | Experimental |
| |
| ensovibep dose 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 viral load | Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs | up to day 29 |
| SARS-CoV-2 viral cultures | Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs | up to day 29 |
| SARS-CoV-2 PCR days to negativity | Duration in days to SARS-CoV-2 PCR negativity | up to day 29 |
| Observed maximum concentration (Cmax) | The maximum observed concentration (Cmax) is estimated based on the serum concentrations. | up to day 91 |
| Terminal Elimination Half-Life (T½) | up to day 91 | |
| Time to Cmax (Tmax) | up to day 91 | |
| The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf) | up to day 91 | |
| The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | up to day 91 | |
| Apparent total body clearance of the drug from plasma (CL) |
| Measure | Description | Time Frame |
|---|---|---|
| 14 Common Covid-19 Related Symptoms score | Changes in the assessment of 14 Common Covid-19 Related Symptoms score | up to day 29 |
| Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 | Netherlands |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000715987 | ensovibep |
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|
| up to day 91 |
| Apparent volume of distribution at steady state (Vss) | up to day 91 |
Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study |
| up to day 91 |
| Concomitant medication | Intake of concomitant medication will be assessed throughout the study | up to day 91 |
| Vital Signs: Heart Rate (bpm) | up to day 91 |
| Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) | up to day 91 |
| Vital Signs: Respiratory Rate (breaths per minute) | up to day 91 |
| Vital Signs: Body Temperature (°C) | up to day 91 |
| Vital Signs: Oxygen Saturation (SpO2) | up to day 91 |
| Clinical laboratory tests (hematology and blood chemistry) | up to day 91 |
| Physical examinations (symptom directed) | up to day 91 |
| Local tolerability at injection site | Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score | up to 90 min post dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |