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?

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.

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+