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Virus Therapy

ACE2 Chewing Gum for COVID-19

Phase 1 & 2

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Stated willingness to abstain from using mouth rinse/gargling solutions at the time of enrollment and for the duration of the study

Male or female, aged 18 years to 65 years

Must not have

Uncontrolled hypertension, defined as ≥160 mmHg systolic or ≥100 mmHg diastolic

Currently undergoing cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of consent through day 28

Summary

This trial tests if ACE2 gum can safely reduce SARS-CoV-2 symptoms over 3 days.

Who is the study for?

This trial is for adults aged 18-65 with a recent positive test for COVID-19, who are not hospitalized and can comply with study procedures like storing saliva samples. They must not use mouthwash or other oral products before tests, avoid certain medications including antivirals and antibiotics, and cannot be pregnant or on cancer treatment.

What is being tested?

The trial is testing the effects of an ACE2 chewing gum against a placebo gum to see if it can reduce the amount of coronavirus in the saliva of people with COVID-19. Participants will chew the gum over three days, and their viral load will be monitored.

What are the potential side effects?

Specific side effects aren't listed but participants should not have allergies to lettuce, gelatin (plant-based), stevia, or objections to genetically modified plant material as these may be present in the chewing gum.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to use any mouthwash during the study.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not higher than 160/100 mmHg.

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I am currently receiving treatment for cancer.

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I am on long-term immune system suppressing drugs or take more than 10 mg of prednisolone daily.

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I am currently taking medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of consent through day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of consent through day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of consent through day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the safety and tolerability of CTB-ACE2 chewing gum.

Secondary study objectives

Evaluate the Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).

Test the antiviral activity of ACE2 chewing gum on reducing SARS-CoV-2 viral load in the oral cavity of COVID-19+ individuals via authorized PCR.

Other study objectives

Test the antiviral activity of ACE2 chewing gum on reducing SARS-CoV-2 viral load in the oral cavity of COVID-19+ individuals via antigen quantitation analysis.