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Virus Therapy

IMM-BCP-01 for COVID-19

Phase 1

Recruiting

Research Sponsored by Immunome, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

Study Summary

This trial is testing a new drug, IMM-BCP-01, to see if it is safe and effective in treating people with mild to moderate COVID-19. The study will last 28 days, and will measure safety, tolerability, and viral clearance.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Anti drug antibody

Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

PK parameters

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: IV Cohort 4 (optional)Experimental Treatment2 Interventions

Single intravenous (IV) dose 4 of IMM-BCP-01 or matching placebo

Group II: IV Cohort 3Experimental Treatment2 Interventions

Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo

Group III: IV Cohort 2Experimental Treatment2 Interventions

Single intravenous (IV) dose 2 of IMM-BCP-01 or matching placebo

Group IV: IV Cohort 1Experimental Treatment2 Interventions

Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

866 Previous Clinical Trials

327,271 Total Patients Enrolled

19 Trials studying COVID-19

6,939 Patients Enrolled for COVID-19

Immunome, Inc.Lead Sponsor

Frequently Asked Questions

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

Does this research include participants who are older than 35 years of age?

"This trial is specifically searching for patients aged 18 to 50 years. In contrast, there are 140 studies targeting minors and 911 trials recruiting persons over 65."

Answered by AI

Could you please explain the safety profile of IMM-BCP-01 for human subjects?

"According to our internal assessment, IMM-BCP-01's safety is tentatively rated a 1 as this trial has only begun Phase 1 and lacks sufficient evidence of efficacy."

Answered by AI

Are there any available slots for enrollees in this research program?

"Clinicaltrials.gov reveals that this research endeavour is actively recruiting participants, with the initial posting having been made on June 3rd 2022 and subsequent updates issued on August 11th of the same year."

Answered by AI

Can I be selected to partake in this experiment?

"To meet the criteria of this clinical trial, applicants must be ages 18 to 50 and have been diagnosed with COVID-19. The trial is currently accepting 36 participants in total."

Answered by AI

How many participants is the maximum capacity of this research endeavor?

"This trial requires 36 qualified patients located in various regions. Two of the participating sites are Icahn School of Medicine at Mt. Sinai, New york and Ark Clinical Research, Long Beach, California."

Answered by AI

To what extent are hospitals participating in this experiment?

"Currently, individuals can sign up for this trial at 4 different locations: New york City, Long Beach, and Miami Lakes are a few of the sites. Choosing to take part at the closest medical centre helps limit your travel burden."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMM-BCP-01 in Mild to Moderate COVID-19

2022. "IMM-BCP-01 in Mild to Moderate COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429021.