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

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

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: ensovibep

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333
    • Centre For Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ensovibep dose 1	Drug: ensovibep; 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.; Other Names: MP0420
Experimental: ensovibep dose 2	Drug: ensovibep; 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.; Other Names: MP0420

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Molecular Partners AG

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Corona; DARPin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MP0420-CP204; 2021-000365-33 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No