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

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

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

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