Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT04828161
Status:
TERMINATED
Last Update Posted:
2023-01-18
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPATHY
Brief 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.
Detailed 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 during the study and its clinical relevance (PK, efficacy and safety)
* To evaluate safety and tolerability of ensovibep
Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.
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 during the study and its clinical relevance (PK, efficacy and safety)
* To evaluate safety and tolerability of ensovibep
Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: