Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients

Study Overview
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Brief Summary
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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

Official Title
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A Phase 2a Open Label, Non-comparative, Single Dose Escalation Study to Evaluate the Dynamics of Viral Clearance, Pharmacokinetics and Tolerability of Ensovibep in Patients With Symptomatic COVID-19 Disease

Conditions
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Covid19

Intervention / Treatment
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* Drug: ensovibep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ensovibep dose 1<br> | Drug: ensovibep<br>* 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.<br>* Other names: MP0420;|
| Experimental: ensovibep dose 2<br> | Drug: ensovibep<br>* 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.<br>* Other names: MP0420;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |  | up to day 91 | 
| Apparent volume of distribution at steady state (Vss) |  | up to day 91 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Corona, DARPin