Covid19
Conditions
Keywords
SARS-CoV-2, Corona, DARPin
Brief summary
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
Interventions
DRUGensovibep
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.
Sponsors
Molecular Partners AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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. * Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
Exclusion criteria
* Requiring hospitalization at time of screening, or at time of study drug administration. * Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute. * Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. * Any co-morbidity requiring hospitalization or surgery within \<7 days, or that is considered life-threatening within 29 days. * A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection. * Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies. * Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study. * Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial. * Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells \<200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study. * Subjects at high risk for of COVID-19 related complications or mortality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 viral load | up to day 29 | Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs |
| SARS-CoV-2 viral cultures | up to day 29 | Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs |
| SARS-CoV-2 PCR days to negativity | up to day 29 | Duration in days to SARS-CoV-2 PCR negativity |
| Observed maximum concentration (Cmax) | up to day 91 | The maximum observed concentration (Cmax) is estimated based on the serum concentrations. |
| 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) | up to day 91 | — |
| Apparent volume of distribution at steady state (Vss) | up to day 91 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 14 Common Covid-19 Related Symptoms score | up to day 29 | Changes in the assessment of 14 Common Covid-19 Related Symptoms score |
| Local tolerability at injection site | up to 90 min post dose | Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score |
| Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs) | up to day 91 | Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study |
| Concomitant medication | up to day 91 | Intake of concomitant medication will be assessed throughout the study |
| 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 | — |
Countries
Netherlands
Outcome results
None listed