SARS-CoV-2Phase 1/2NCT05433181
ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)
A Phase 1/2 study testing ACE2 Chewing Gum in people with SARS-CoV-2, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- ACE2 Chewing Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to 1 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent prior to initiation of study procedures.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years to 65 years.
- Had a positive PCR or antigen test for SARS-CoV-2 within 72 hours of enrollment.
- In the opinion of the investigator, has the ability to comply with study procedures including chewing the study products (gum).
- 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.
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- Stated willingness to abstain from eating mints or other chewing gums during the duration of the study.
- Stated willingness to abstain from using mouth rinse/gargling solutions at the time of enrollment and for the duration of the study.
- 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.
- Stated ability and willingness to store saliva samples at approximately 40° F for 3 days.
Who cannot join
- Individuals receiving antiviral medications that are thought to be active against SARS-CoV-2 in the opinion of the investigator.
- Individuals receiving oral or injectable antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
- Currently undergoing cancer treatment.
- Pregnant or breastfeeding women.
- Participation in any other clinical trial within the past 14 days that used an investigational drug product.
- 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.
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- Taking chronic immunosuppressive medications at time of enrollment, defined as immunomodulatory agents or a prednisolone dose greater than 10 mg a day.
- Uncontrolled hypertension, defined as ≥160 mmHg systolic or ≥100 mmHg diastolic.
- Allergy/hypersensitivity to lettuce, gelatin (plant based), stevia, or unwillingness to consume genetically modified plant material.
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Diseases Clinical Trial Unit
Philadelphia, Pennsylvania, 19104
About this study
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)
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.
- Conditions
- SARS-CoV-2
- Being tested
- ACE2 Chewing Gum, Placebo Chewing Gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE2 Chewing GumDrug
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 Chewing GumOther
Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP.
| Study group | Role | What they receive |
|---|---|---|
| ACE2 Chewing Gum | Experimental | Not described Receives: Drug: ACE2 Chewing Gum |
| Placebo Chewing Gum | Placebo comparator | Not described Receives: Other: Placebo Chewing Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At time of consent through Day 28
Secondary outcomes (2)
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.
Measured: Days 1-4
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).
Measured: Days 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startFeb 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Why it stopped: For administrative reasons, the study was never opened and was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433181
- Sponsor's protocol ID
- 851459
- Status last verified
- Mar 2025
- First submitted
- 24 Jun 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganesan PK, Kulchar RJ, Kaznica P, Montoya-Lopez R, Green BJ, Streatfield SJ, Daniell H. Optimization of biomass and target protein yield for Phase III clinical trial to evaluate Angiotensin Converting Enzyme 2 expressed in lettuce chloroplasts to reduce SARS-CoV-2 infection and transmission. Plant Biotechnol J. 2023 Feb;21(2):244-246. doi: 10.1111/pbi.13954. Epub 2022 Dec 1. No abstract available.
PubMed 36314106
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05433181
- Acronym / sponsor ID
- 851459
- Conditions
- SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: For administrative reasons, the study was never opened and was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE2 Chewing Gum | Experimental | Drug: ACE2 Chewing Gum |
| Placebo Chewing Gum | Placebo comparator | Other: Placebo Chewing Gum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide informed consent prior to initiation of study procedures.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years to 65 years.
- Had a positive PCR or antigen test for SARS-CoV-2 within 72 hours of enrollment.
- In the opinion of the investigator, has the ability to comply with study procedures including chewing the study products (gum).
Key exclusion criteria (9 listed)
- Individuals receiving antiviral medications that are thought to be active against SARS-CoV-2 in the opinion of the investigator.
- Individuals receiving oral or injectable antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
- Currently undergoing cancer treatment.
- Pregnant or breastfeeding women.
- Participation in any other clinical trial within the past 14 days that used an investigational drug product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE2 Chewing GumThe 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. | Drug | ACE2 Chewing Gum |
| Placebo Chewing GumChewing gum containing wild-type lyophilized plant cells manufactured to match the IP. | Other | Placebo Chewing Gum |
Primary outcome
Evaluate the safety and tolerability of CTB-ACE2 chewing gum.
Time frame: 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).
2 secondary outcomes
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.
Time frame: Days 1-4
Evaluate the Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).
Time frame: Days 1-4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 36314106Ganesan PK, Kulchar RJ, Kaznica P, Montoya-Lopez R, Green BJ, Streatfield SJ, Daniell H. Optimization of biomass and target protein yield for Phase III clinical trial to evaluate Angiotensin Converting Enzyme 2 expressed in lettuce chloroplasts to reduce SARS-CoV-2 infection and transmission. Plant Biotechnol J. 2023 Feb;21(2):244-246. doi: 10.1111/pbi.13954. Epub 2022 Dec 1. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACE2 Chewing Gum in people with SARS-CoV-2, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of CTB-ACE2 chewing gum. (time frame: At time of consent through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.