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

NCT04834856 | Completed Phase 2

• 2 other identifiers: MP0420-CP2042021-000365-33
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

SARS-CoV-2; Corona; DARPin

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (11)

• 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)

  up to day 91

• Concomitant medication

  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

Study Arms (2)

ensovibep dose 1

EXPERIMENTAL

Drug: ensovibep

ensovibep dose 2

EXPERIMENTAL

Drug: ensovibep

Interventions

ensovibep DRUG

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.

Also known as: MP0420

ensovibep dose 1; ensovibep dose 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Molecular Partners AG: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333, Netherlands

Location

MeSH Terms

Conditions

COVID-19

Interventions

ensovibep

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

NL (1)