v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05433181 |
|
Full text link
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
HUP-IDCTU@uphs.upenn.edu |
|
Registration date
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2022-06-27 |
|
Recruitment status
Last imported at : Dec. 22, 2023, 4 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Oct. 27, 2023, 8 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 20, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: able and willing to provide informed consent prior to initiation of study procedures. stated willingness to comply with all study procedures and availability for the duration of the study. male or female, aged 18 years to 65 years. had a positive pcr or antigen test for sars-cov-2 within 72 hours of enrollment. in the opinion of the investigator, has the ability to comply with study procedures including chewing the study products (gum). 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. stated willingness to abstain from eating mints or other chewing gums during the duration of the study. stated willingness to abstain from using mouth rinse/gargling solutions at the time of enrollment and for the duration of the study. 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. stated ability and willingness to store saliva samples at approximately 40° f for 3 days. |
|
Exclusion criteria
Last imported at : Aug. 20, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
individuals receiving antiviral medications that are thought to be active against sars-cov-2 in the opinion of the investigator. individuals receiving oral or injectable antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment. currently undergoing cancer treatment. pregnant or breastfeeding women. participation in any other clinical trial within the past 14 days that used an investigational drug product. 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. taking chronic immunosuppressive medications at time of enrollment, defined as immunomodulatory agents or a prednisolone dose greater than 10 mg a day. uncontrolled hypertension, defined as ≥160 mmhg systolic or ≥100 mmhg diastolic. allergy/hypersensitivity to lettuce, gelatin (plant based), stevia, or unwillingness to consume genetically modified plant material. |
|
Number of arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
University of Pennsylvania |
|
Inclusion age min
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Aug. 20, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : Oct. 27, 2023, 8 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
40 |
|
primary outcome
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Evaluate the safety and tolerability of CTB-ACE2 chewing gum. |
|
Notes
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "chewing gum", "treatment_id": 1752, "treatment_name": "Angiotensin-converting enzyme inhibitors", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "chewing gum", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |