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

NCT ID: NCT04834856

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-08-20

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ensovibep dose 1

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: 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.

ensovibep dose 2

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

MP0420

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molecular Partners AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

2021-000365-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MP0420-CP204

Identifier Type: -

Identifier Source: org_study_id