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

Phase 1

Withdrawn

• Conditions: SARS-CoV-2
• Interventions: Other: Placebo Chewing Gum; Drug: ACE2 Chewing Gum

• Registration Number: NCT05433181
• Lead Sponsor: University of Pennsylvania

Brief Summary

A randomized double-blind, placebo controlled clinical trial of the safety, tolerability, and antiviral activity of angiotensin-converting enzyme 2 (ACE2) chewing gum over a 3-day period in non-hospitalized subjects with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-27
• Study Start: 2025-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Able and willing to provide informed consent prior to initiation of study procedures.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 years to 65 years.
4. Had a positive PCR or antigen test for SARS-CoV-2 within 72 hours of enrollment.
5. In the opinion of the investigator, has the ability to comply with study procedures including chewing the study products (gum).
6. Stated willingness to refrain from brushing, eating or using any oral health care products, including mouth rinses at least one hour prior to first saliva sample.
7. Stated willingness to abstain from eating mints or other chewing gums during the duration of the study.
8. Stated willingness to abstain from using mouth rinse/gargling solutions at the time of enrollment and for the duration of the study.
9. Stated willingness to use an acceptable method of birth control throughout duration of the study. Acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the PI.
10. Stated ability and willingness to store saliva samples at approximately 40° F for 3 days.

Exclusion Criteria

1. Individuals receiving antiviral medications that are thought to be active against SARS-CoV-2 in the opinion of the investigator.
2. Individuals receiving oral or injectable antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
3. Currently undergoing cancer treatment.
4. Pregnant or breastfeeding women.
5. Participation in any other clinical trial within the past 14 days that used an investigational drug product.
6. Admitted to the hospital or other medical facility or in the opinion of the investigator expected to require admission to a medical facility for the duration of the study.
7. Taking chronic immunosuppressive medications at time of enrollment, defined as immunomodulatory agents or a prednisolone dose greater than 10 mg a day.
8. Uncontrolled hypertension, defined as ≥160 mmHg systolic or ≥100 mmHg diastolic.
9. Allergy/hypersensitivity to lettuce, gelatin (plant based), stevia, or unwillingness to consume genetically modified plant material.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Chewing Gum	Placebo Chewing Gum	-
ACE2 Chewing Gum	ACE2 Chewing Gum	-

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of CTB-ACE2 chewing gum.	At time of consent through Day 28	The safety and tolerability in COVID 19+ adult individuals as measured by frequency of solicited adverse events (AEs).

Secondary Outcome Measures

Name	Time	Method
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.	Days 1-4	The change in amount of SARS-CoV-2 in saliva before and after intervention (chewing gum for 10 minutes) via authorized PCR; this includes after first use and sustained use over 3 days.
Evaluate the Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).	Days 1-4	Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).

Trial Locations

Locations (1)

Infectious Diseases Clinical Trial Unit; 🇺🇸 Philadelphia, Pennsylvania, United States