SARS-CoV-2 infection (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Ensovibep
Product Code: MP0420
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ensovibep
Current Sponsor code: MP0420
Other descriptive name: DARPin targeting three diffe
Sponsors
Molecular Partners AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant women, between 18 and 70 years on the day of inclusion. 2. 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. 3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). 4. Female subjects must agree to use highly effective contraception as described in section 4.5.1 or must be of non-childbearing potential. A woman is considered to be of non-childbearing potential if she meets one of the following criteria: a. be post-menopausal (spontaneous amenorrhea for at least 12 months,); or b. has no uterus, ovaries or fallopian tubes. 5. Agree to follow the contraception requirements of the trial as described in section 4.5.1. 6. Understand and agree to comply with planned study procedures, including nasopharyngeal swabs and venous blood samples. 7. Able to communicate well with the investigator in the Dutch language and has provided signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 39 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Requiring hospitalization at time of screening, or at time of study drug administration. 2. Oxygen saturation (SpO2) = 93 percent (%) on room air at sea level, respiratory rate = 30 per minute, or heart rate =125 per minute. 3. Known allergies to any of the components used in the i.v. formulation of ensovibep. 4. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. 5. Any co-morbidity requiring hospitalization or surgery within 35 kg/m2 ii. Chronic Cardiac or pulmonary disease (e.g. atrial fibrillation, CAD, heart failure, COPD, asthma), that might pose additional risks in study participation, as per investigator decision iii. Ongoing clinically significant neurological disease (e.g. stroke or any other chronic debilitating neurological disease) iv. Chronic kidney disease with GFR 1 year (excluding baso -or spinocellular skin cancers) vii. Chronic liver disease (liver cirrhosis Child Pugh A/B/C or other disease leading to liver dysfunction) as per medical history b. Age < 50 years with 3 or more of the above-mentioned risk factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To characterize the dynamics of viral clearance (incl. viral cultures, qPCR) following ensovibep administration • To evaluate the serum pharmacokinetics of single, i.v. doses of ensovibep in patients with symptomatic COVID-19 disease ;Secondary Objective: • To observe the evolution of clinical symptoms for COVID-19 following ensovibep administration • To characterize the tolerability of two single i.v. flat dose levels of ensovibep in patients with symptomatic COVID-19 disease ;Primary end point(s): • Changes from baseline to each time point of measurement in viral load (quantitative PCR) and viral cultures, as per assessment schedule • Duration in days to PCR negativity • Measurement of ensovibep in serum and assess PK paramenters (including Cmax, T1/2, Tmax, AUCinf, AUClast, CL, Vss) ;Timepoint(s) of evaluation of this end point: Day 1 - FFU | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in the Assessment of 14 Common COVID-19-Related Symptoms score per the assessment schedule • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit • Adverse events of special interest (AESIs) • Infusion-related reactions (IRRs) • Concomitant medication throughout the study at every study visit • Vital signs (pulse rate (bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate, temperature (ºC), and oxygen saturation (%)) as per the assessment schedule • Clinical laboratory tests (hematology and blood chemistry) as per the assessment schedule • Physical examinations (symptom directed) at every study visit • Assessment of local tolerability at injection site (Visual Infusion Phlebitis score) ;Timepoint(s) of evaluation of this end point: Day 1 - Day 91 | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Centre for Human Drug Research
Outcome results
None listed