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-dayperiod in non-hospitalized subjects with Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) infection.
Not Provided
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.
Other: Placebo Chewing Gum
Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP.
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.
Infectious Diseases Clinical Trial Unit
Philadelphia, Pennsylvania, United States
Investigator: Infectious Diseases Clinical Trial Unit
Contact: 215-349-8092
HUP-IDCTU@uphs.upenn.edu
Infectious Diseases Clinical Trials Unit
215-349-8092
HUP-IDCTU@uphs.upenn.edu
Not Provided