COVID-19 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial
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
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 ;
| NCT number | NCT04828161 |
| Study type | Interventional |
| Source | Molecular Partners AG |
| Contact | Medical Director MPAG |
| Phone | +41 44 755 7700 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | Phase 2/Phase 3 |
| Start date | April 15, 2021 |
| Completion date | June 2022 |
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