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Immunomodulator
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
Ankara, Turkey
Phase 2
Waitlist Available
Led By Reynold Panettieri, MD
Research Sponsored by Evelo Biosciences, Inc.
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 42 days
Summary
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
See full description
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Secondary study objectives
Change in S/F Ratio
Incidence of Clinically Significant Abnormal Lab Parameters
Intubation and Mechanical-ventilation Free Survival
+15 moreSide effects data
From 2021 Phase 2 trial • 249 Patients • NCT0460302713%
Headache
7%
Upper Respiratory Tract Infection
4%
COVID-19
4%
Diarrhea
4%
Vaccination Complication
4%
Viral Upper Respiratory Tract Infection
2%
COVID-19 Pneumonia
2%
Abdominal Pain
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
Cohort 1 Active
Cohort 2 Active
Cohort 3 Active
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP1815Experimental Treatment1 Intervention
Patients will receive EDP1815 in addition to standard of care
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive placebo in addition to standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP1815
2020
Completed Phase 3
~1370
Find a Location
Closest Location:Robert Wood Johnson University Hospital· New Brunswick, NJ
Who is running the clinical trial?
Evelo Biosciences, Inc.Lead Sponsor
10 Previous Clinical Trials
1,490 Total Patients Enrolled
Reynold Panettieri, MDPrincipal InvestigatorRutgers, The State University of New Jersey
1 Previous Clinical Trials
Douglas Maslin, MDStudy DirectorEvelo Biosciences
1 Previous Clinical Trials
287 Total Patients Enrolled