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

NCT05433181 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-04-01
Completion
2025-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05433181 on ClinicalTrials.gov