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Clinical Trial Summary

The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients


Clinical Trial Description

Primary objectives: Part A The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8. Part B The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29. Secondary objectives: Part A The secondary objectives of this Part are: - To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29 - To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29 - To evaluate safety and tolerability of ensovibep - To characterize the pharmacokinetics (PK) of ensovibep Part B The secondary objectives of this Part are: - To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8 - To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29 - To evaluate the immunogenicity of ensovibep and its clinical relevance (pharmacokinetic, efficacy, and safety). - To evaluate safety and tolerability of ensovibep ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04828161
Study type Interventional
Source Molecular Partners AG
Contact Medical Director MPAG
Phone +41 44 755 7700
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date April 15, 2021
Completion date June 2022

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