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Monoclonal Antibodies

ensovibep for COVID-19 (EMPATHY Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on day 1, and at days 3, 8, 15, 29, 61 and 91
Awards & highlights

EMPATHY Trial Summary

This study is evaluating whether ensovibep can be used to treat COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

EMPATHY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on day 1, and at days 3, 8, 15, 29, 61 and 91
This trial's timeline: 3 weeks for screening, Varies for treatment, and data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on day 1, and at days 3, 8, 15, 29, 61 and 91 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8
Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause
Secondary outcome measures
Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep
Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep
Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep
+13 more

EMPATHY Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3/ Part B, ensovibep active treatment arm 4Experimental Treatment1 Intervention
Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.
Group II: Phase 2 / Part A, ensovibep active treatment arm 3Experimental Treatment1 Intervention
Phase 2 / Part A: ensovibep active treatment arm 3
Group III: Phase 2 / Part A, ensovibep active treatment arm 2Experimental Treatment1 Intervention
Phase 2 / Part A: ensovibep active treatment arm 2
Group IV: Phase 2 / Part A, ensovibep active treatment arm 1Experimental Treatment1 Intervention
Phase 2 / Part A: ensovibep active treatment arm 1
Group V: Phase 3/ Part B, Placebo armPlacebo Group1 Intervention
Phase 3/ Part B: Placebo. Part B was not initiated.
Group VI: Phase 2 / Part A, PlaceboPlacebo Group1 Intervention
Phase 2 / Part A: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ensovibep
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,197,837 Total Patients Enrolled
11 Trials studying COVID-19
1,280 Patients Enrolled for COVID-19
Molecular Partners AGIndustry Sponsor
13 Previous Clinical Trials
3,628 Total Patients Enrolled
4 Trials studying COVID-19
3,303 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Gastrointestinal and Liver Consultants
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
2021. "A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828161.
~104 spots leftby Apr 2025
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