Status:
COMPLETED
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Lead Sponsor:
Molecular Partners AG
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04834856
Start Date
April 1 2021
End Date
August 20 2021
Last Update
September 8 2021
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333