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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ACE2 Chewing Gum
  • 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.
Placebo Comparator
Placebo Chewing Gum
  • Other: Placebo Chewing Gum
    Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP.

Recruiting Locations

More Details

NCT ID
NCT05433181
Status
Withdrawn
Sponsor
University of Pennsylvania

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.