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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Centre for Human Drug Research
Leiden, Netherlands
SARS-CoV-2 viral load
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
Time frame: 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
Time frame: up to day 29
SARS-CoV-2 PCR days to negativity
Duration in days to SARS-CoV-2 PCR negativity
Time frame: up to day 29
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time frame: up to day 91
Terminal Elimination Half-Life (T½)
Time frame: up to day 91
Time to Cmax (Tmax)
Time frame: up to day 91
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
Time frame: up to day 91
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: up to day 91
Apparent total body clearance of the drug from plasma (CL)
Time frame: up to day 91
Apparent volume of distribution at steady state (Vss)
Time frame: up to day 91
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14 Common Covid-19 Related Symptoms score
Changes in the assessment of 14 Common Covid-19 Related Symptoms score
Time frame: up to day 29
Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study
Time frame: up to day 91
Concomitant medication
Intake of concomitant medication will be assessed throughout the study
Time frame: up to day 91
Vital Signs: Heart Rate (bpm)
Time frame: up to day 91
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time frame: up to day 91
Vital Signs: Respiratory Rate (breaths per minute)
Time frame: up to day 91
Vital Signs: Body Temperature (°C)
Time frame: up to day 91
Vital Signs: Oxygen Saturation (SpO2)
Time frame: up to day 91
Clinical laboratory tests (hematology and blood chemistry)
Time frame: up to day 91
Physical examinations (symptom directed)
Time frame: up to day 91
Local tolerability at injection site
Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score
Time frame: up to 90 min post dose