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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
Male or female 18 to 50 years of age, inclusive, at the time of signing the informed consent.
Subjects must have mild to moderate COVID-19 with symptom onset within 5 days prior to study drug administration (see Appendix 13.1 for Food and Drug Administration [FDA] severity guidance). Subjects whose symptoms began >5 days (i.e. ˃120 hours) prior to dosing or whose time of symptom onset cannot be accurately assessed are not eligible.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 to 50 years old and have given your permission to participate in the study.
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You must have mild to moderate COVID-19 symptoms that started no more than 5 days ago. If your symptoms started more than 5 days ago or it's unclear when they started, you cannot participate in the study.
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You must have at least two of the common COVID-19 symptoms, such as fever, cough, sore throat, runny nose, headache, muscle pain, nausea, vomiting, diarrhea, or loss of taste or smell. The Principal Investigator may also consider other symptoms related to COVID-19.
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You must have enough oxygen in your blood without the help of additional oxygen.
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Your body mass index (BMI) is between 18 and 30 kilograms per square meter.
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You weigh at least 88 pounds at the time of screening.
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If you are sexually active and can have children, you must use a reliable form of birth control starting from the time you agree to participate in the study until 90 days after receiving the study drug.
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If you're a male, you must wait at least 90 days after taking the study drug before donating sperm.
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You were in good health before getting COVID-19 and don't have any major medical issues.
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You must be generally healthy and not have any major medical issues when you are screened by the study team.

Timeline

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

Find a Location

Who is running the clinical trial?

Immunome, Inc.Lead Sponsor
United States Department of DefenseFED
856 Previous Clinical Trials
225,559 Total Patients Enrolled
19 Trials studying COVID-19
6,939 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.

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
~13 spots leftby Mar 2025