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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of consent through day 28

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ACE2 Chewing GumExperimental Treatment1 Intervention

Group II: Placebo Chewing GumPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,959 Total Patients Enrolled

32 Trials studying COVID-19

6,273,977 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.

Is this experiment still taking in participants?

"According to the most recent update on clinicaltrials.gov, this trial is in search of participants and has been since November 1st 2023. The post was last revised October 25th 2023."

Answered by AI

Is geriatric involvement sought in this trial?

"This medical trial is open to participants between 18 and 65 years of age. There are separate trials for those under the age of 18 (21) and over 65 (99)."

Answered by AI

How many individuals are involved in this clinical research endeavor?

"Affirmative. The details on clinicaltrials.gov demonstrate that the recruiting process for this medical trial has commenced; it was first shared on November 1st 2023 and its most recent update occurred October 25th 2023. 40 patients are expected to be recruited from one site."

Answered by AI

Am I eligible to participate in this research project?

"This medical trial is enrolling 40 adults aged between 18 and 65 who have tested positive for the SARS-CoV-2 virus within 72 hours of enrolment. Candidates must satisfy various criteria, such as: willing to provide their informed consent before procedure initiation; commitment to comply with all study protocols; capacity to follow instructions concerning chewing products (gum) ingestion; abstinence from brushing teeth, eating or using oral health care items including mouthwash one hour prior to saliva sample collection; abstaining from consuming mints and other gums over the duration of the experiment; refraining from gargling solutions at time of registration and throughout study"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

2025. "ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05433181.

All > Covid 19