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For administrative reasons, the study was never opened and was terminated.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE2 Chewing Gum | Experimental |
| |
| Placebo Chewing Gum | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE2 Chewing Gum | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At time of consent through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-4 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Clinical Trial Unit | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36314106 | Derived | Ganesan PK, Kulchar RJ, Kaznica P, Montoya-Lopez R, Green BJ, Streatfield SJ, Daniell H. Optimization of biomass and target protein yield for Phase III clinical trial to evaluate Angiotensin Converting Enzyme 2 expressed in lettuce chloroplasts to reduce SARS-CoV-2 infection and transmission. Plant Biotechnol J. 2023 Feb;21(2):244-246. doi: 10.1111/pbi.13954. Epub 2022 Dec 1. No abstract available. |
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|
| Placebo Chewing Gum | Other | Chewing gum containing wild-type lyophilized plant cells manufactured to match the IP. |
|
| 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). |
| Days 1-4 |