NCT05433181

ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

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)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2022-06-27
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study