Clinical trial NCT05433181: ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the safety and tolerability of CTB-ACE2 chewing gum.
timeFrame: At time of consent through Day 28
Secondary outcomes:
measure: 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.
timeFrame: Days 1-4
measure: Evaluate the Symptom score of documented SARS-CoV-2 infection relative to treatment group (CTB-ACE2 chewing gum/placebo).
timeFrame: Days 1-4
Other outcomes:
measure: 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.
timeFrame: Days 1-4
Locations:
city: Philadelphia
country: United States
facility: Infectious Diseases Clinical Trial Unit
state: Pennsylvania
Study officials:
References: