Back to resultsViral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
ensovibep
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, Corona, DARPin
Eligibility Criteria
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
Sites / Locations
- Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ensovibep dose 1
ensovibep dose 2
Arm Description
Outcomes
Primary Outcome Measures
SARS-CoV-2 viral load
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
SARS-CoV-2 viral cultures
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
Duration in days to SARS-CoV-2 PCR negativity
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Terminal Elimination Half-Life (T½)
Time to Cmax (Tmax)
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Apparent total body clearance of the drug from plasma (CL)
Apparent volume of distribution at steady state (Vss)
Secondary Outcome Measures
14 Common Covid-19 Related Symptoms score
Changes in the assessment of 14 Common Covid-19 Related Symptoms score
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
Concomitant medication
Intake of concomitant medication will be assessed throughout the study
Vital Signs: Heart Rate (bpm)
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Vital Signs: Respiratory Rate (breaths per minute)
Vital Signs: Body Temperature (°C)
Vital Signs: Oxygen Saturation (SpO2)
Clinical laboratory tests (hematology and blood chemistry)
Physical examinations (symptom directed)
Local tolerability at injection site
Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834856
Brief Title
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Partners AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, Corona, DARPin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ensovibep dose 1
Arm Type
Experimental
Arm Title
ensovibep dose 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ensovibep
Other Intervention Name(s)
MP0420
Intervention Description
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.
Primary Outcome Measure Information:
Title
SARS-CoV-2 viral load
Description
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
Time Frame
up to day 29
Title
SARS-CoV-2 viral cultures
Description
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
Title
SARS-CoV-2 PCR days to negativity
Description
Duration in days to SARS-CoV-2 PCR negativity
Time Frame
up to day 29
Title
Observed maximum concentration (Cmax)
Description
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time Frame
up to day 91
Title
Terminal Elimination Half-Life (T½)
Time Frame
up to day 91
Title
Time to Cmax (Tmax)
Time Frame
up to day 91
Title
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
Time Frame
up to day 91
Title
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
Title
Apparent total body clearance of the drug from plasma (CL)
Time Frame
up to day 91
Title
Apparent volume of distribution at steady state (Vss)
Time Frame
up to day 91
Secondary Outcome Measure Information:
Title
14 Common Covid-19 Related Symptoms score
Description
Changes in the assessment of 14 Common Covid-19 Related Symptoms score
Time Frame
up to day 29
Title
Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
Description
Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study
Time Frame
up to day 91
Title
Concomitant medication
Description
Intake of concomitant medication will be assessed throughout the study
Time Frame
up to day 91
Title
Vital Signs: Heart Rate (bpm)
Time Frame
up to day 91
Title
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time Frame
up to day 91
Title
Vital Signs: Respiratory Rate (breaths per minute)
Time Frame
up to day 91
Title
Vital Signs: Body Temperature (°C)
Time Frame
up to day 91
Title
Vital Signs: Oxygen Saturation (SpO2)
Time Frame
up to day 91
Title
Clinical laboratory tests (hematology and blood chemistry)
Time Frame
up to day 91
Title
Physical examinations (symptom directed)
Time Frame
up to day 91
Title
Local tolerability at injection site
Description
Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score
Time Frame
up to 90 min post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre for Human Drug Research
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
12. IPD Sharing Statement
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Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
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