A Phase 1/2 interventional study of ACE2 Chewing Gum and Placebo Chewing Gum in SARS-CoV-2, sponsored by University of Pennsylvania. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University of Pennsylvania · Phase 1/2, Interventional, and Prevention
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ACE2 Chewing Gum
Other: Placebo 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.
Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP.
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).
Time frame: At time of consent through Day 28
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.
Time frame: 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).
Time frame: Days 1-4
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.
The change in amount of SARS-CoV-2 in saliva before and after intervention (chewing gum for 10 minutes) via antigen quantitation analysis; this includes after first use and sustained use over 3 days.
Time frame: Days 1-4
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania