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

SARS-CoV-2 Clinical Trial

Official title:

A Phase 1/2, Randomized Double-blind Placebo-Controlled Trial to Test the Safety and Antiviral Activity of ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05433181
• Other study ID #: 851459
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2025
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Infectious Diseases Clinical Trials Unit
• Phone: 215-349-8092
• Email: HUP-IDCTU[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Drug:
• ACE2 Chewing Gum
The IP is formulated as an oral plant powder, which is packaged into a chewing gum. No specific excipient, buffer, salt or pH is required. CTB-ACE2, with efficient binding to both GM1 and ACE2 receptors, effectively blocks binding of the spike protein and viral entry into human cells. Oral epithelial cells are enriched with both receptors. In addition, ACE2 directly binds to the spike protein and inactivates SARS-CoV-2 virus. Therefore, CTB-ACE2 chewing gum is being evaluated for impact on entry and transmission of SARS-CoV-2.

Other:
• Placebo Chewing Gum
Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP.

Locations

Country	Name	City	State
United States	Infectious Diseases Clinical Trial Unit	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	The change in amount of SARS-CoV-2 in saliva before and after intervention (chewing gum for 10 minutes) via antigen quantitation analysis; this includes after first use and sustained use over 3 days.	Days 1-4
Primary	Evaluate the safety and tolerability of CTB-ACE2 chewing gum.	The safety and tolerability in COVID 19+ adult individuals as measured by frequency of solicited adverse events (AEs).	At time of consent through Day 28
Secondary	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.	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.	Days 1-4
Secondary	Evaluate the Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).	Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).	Days 1-4