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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834856
• Other study ID #: MP0420-CP204
• Secondary ID: 2021-000365-33
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: Molecular Partners AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Partners AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	SARS-CoV-2 PCR days to negativity	Duration in days to SARS-CoV-2 PCR negativity	up to day 29
Primary	Observed maximum concentration (Cmax)	The maximum observed concentration (Cmax) is estimated based on the serum concentrations.	up to day 91
Primary	Terminal Elimination Half-Life (T½)		up to day 91
Primary	Time to Cmax (Tmax)		up to day 91
Primary	The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)		up to day 91
Primary	The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)		up to day 91
Primary	Apparent total body clearance of the drug from plasma (CL)		up to day 91
Primary	Apparent volume of distribution at steady state (Vss)		up to day 91
Secondary	14 Common Covid-19 Related Symptoms score	Changes in the assessment of 14 Common Covid-19 Related Symptoms score	up to day 29
Secondary	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
Secondary	Concomitant medication	Intake of concomitant medication will be assessed throughout the study	up to day 91
Secondary	Vital Signs: Heart Rate (bpm)		up to day 91
Secondary	Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)		up to day 91
Secondary	Vital Signs: Respiratory Rate (breaths per minute)		up to day 91
Secondary	Vital Signs: Body Temperature (°C)		up to day 91
Secondary	Vital Signs: Oxygen Saturation (SpO2)		up to day 91
Secondary	Clinical laboratory tests (hematology and blood chemistry)		up to day 91
Secondary	Physical examinations (symptom directed)		up to day 91
Secondary	Local tolerability at injection site	Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score	up to 90 min post dose