ACE2 Chewing Gum for COVID-19

Overseen By Infectious Diseases Clinical Trials Unit

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Must not be taking: Antivirals, Antimicrobials, Immunosuppressants

Disqualifiers: Cancer treatment, Pregnancy, Uncontrolled hypertension, others

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special chewing gum containing ACE2, a protein that might reduce the effects of COVID-19. The researchers aim to determine if the gum is safe, easy to use, and effective in fighting the virus in non-hospitalized individuals. Participants will chew either the ACE2 gum or a placebo (a gum with no active ingredient) for three days. This trial may suit those who tested positive for COVID-19 with a PCR or antigen test in the last three days and are willing to follow study rules, such as avoiding mouthwash or other gums. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are on antiviral or antimicrobial medications, or chronic immunosuppressive drugs, you cannot participate in the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ACE2 chewing gum is being tested for safety in humans. The gum contains a protein that might reduce the amount of the COVID-19 virus in saliva. In earlier studies, the gum significantly reduced virus levels in saliva samples from COVID-19 patients.

Regarding safety, ACE2 chewing gum has been tested in other studies with adults who have COVID-19. These studies examined how well people tolerate the gum and the frequency of any side effects. So far, the data suggest that people generally tolerate the gum well, though specific details about side effects are not provided in the sources.

Since the trial is in its early stages, the main goal is to assess the gum's safety and how people respond to it. Any serious safety issues are likely to be identified in these studies. Overall, while more information is needed, early results suggest the gum is safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for COVID-19, which often involve antiviral medications or vaccines, ACE2 Chewing Gum offers a novel approach by using the ACE2 protein to potentially trap and reduce viral particles in the mouth. This method targets the virus at its entry point, possibly lowering the viral load before it spreads further into the body. Researchers are excited about this treatment because it provides an innovative delivery method that is easy to use and could complement existing therapies by adding a layer of protection right at the source.

What evidence suggests that ACE2 Chewing Gum might be an effective treatment for COVID-19?

Research has shown that ACE2 chewing gum, which participants in this trial may receive, might help lower the amount of the COVID-19 virus in the mouth. One study found that this gum reduced virus-related proteins in COVID-19 patients, even in small amounts. Another study discovered that the gum cut down the virus in saliva by over 95%. The gum is designed to capture the virus, potentially preventing its spread. Early lab tests also showed that the gum could block the virus from entering certain cells. These findings suggest that ACE2 chewing gum could be useful in managing COVID-19. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can follow the study's rules and chew gum as required.

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

I agree not to use any mouthwash during the study.

Exclusion Criteria

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

Allergy/hypersensitivity to lettuce, gelatin (plant based), stevia, or unwillingness to consume genetically modified plant material

My blood pressure is not higher than 160/100 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive ACE2 chewing gum or placebo for 3 days to evaluate safety, tolerability, and antiviral activity

3 days

Daily visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ACE2 Chewing Gum
• Placebo Chewing Gum

Trial Overview 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.

How Is the Trial Designed?

Group I: ACE2 Chewing Gum Experimental Treatment 1 Intervention

Group II: Placebo Chewing Gum Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05433181

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) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0142961222003118

Debulking different Corona (SARS-CoV-2 delta, omicron, ... In addition, CTB-ACE2 chewing gum was able to markedly debulk SARS-CoV-2 (>95%) in COVID-19 patient saliva or swab samples as measured by microbubbles or qPCR [ ...

3. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(23)00011-3/fulltext

Advances in developing ACE2 derivatives against SARS ... Pseudovirus neutralisation assays have shown that CTB-ACE2 chewing gum can effectively prevent SARS-CoV-2 entry into Vero cells and Chinese ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8580552/

Debulking SARS-CoV-2 in saliva using angiotensin ... ACE2 gum decreased the amount of nucleocapsid antigens in COVID-19 patient samples even at very low concentration (25 mg), whereas each gum weighs 2 g. These ...

5. dental.upenn.edu dental.upenn.edu/news-events/2022/09/08/chewing-gum-designed-to-trap-sars-cov-2-in-the-saliva-moves-to-clinical-trial-from-dr-henry-daniells-lab/

Chewing Gum Designed to Trap SARS-CoV-2 in the Saliva ... A recently launched clinical trial at Penn will evaluate a unique chewing gum designed by Penn Dental Medicine's Dr. Henry Daniell to trap SARS-CoV-2 in the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05433181?term=SARS-&cond=COVID&viewType=Table&rank=4

ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19) There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...