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

Molecular Partners

Status and phase

Completed

Phase 2

Conditions

Covid19

Treatments

Drug: ensovibep

Study type

Interventional

Funder types

Industry

Identifiers

NCT04834856

2021-000365-33 (EudraCT Number)

MP0420-CP204

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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