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

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: ensovibep

• Registration Number: NCT04834856
• Lead Sponsor: Molecular Partners AG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ensovibep dose 2	ensovibep	-
ensovibep dose 1	ensovibep	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
14 Common Covid-19 Related Symptoms score	up to day 29	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)	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: Oxygen Saturation (SpO2)	up to day 91
Clinical laboratory tests (hematology and blood chemistry)	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
Physical examinations (symptom directed)	up to day 91
Local tolerability at injection site	up to 90 min post dose	Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands