Study Stopped
The financier of this research project died due to covid-19, Therefore, this project was stopped due to lack of funds
Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19
1 other identifier
interventional
N/A
1 country
1
Brief Summary
180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours. At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedStudy Start
First participant enrolled
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2020
CompletedAugust 3, 2022
August 1, 2022
1 month
July 9, 2020
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
PCR test
Laboratory PCR testing can help diagnose the disease
up to 1 month
Secondary Outcomes (4)
Laboratory Treatment Response
up to 1 month
drug reactions Adverse
up to 1 month
Allergic drug
up to 1 month
Radiological Treatment Response
up to 1 month
Study Arms (3)
Control Group
ACTIVE COMPARATORParticipants in this group use personal protective equipment in the face of patients with COVID-19
Intervention Group 1
EXPERIMENTALIn this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.
Intervention Group 2
EXPERIMENTALIn this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.
Interventions
200 mg of hydroxychloroquine daily for participants in the intervention group 1
Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.
Personal protective equipment such as masks, gloves, protective shields
Eligibility Criteria
You may qualify if:
- Negative PCR testing through throat swabs
- Signing Conscious Consent
You may not qualify if:
- History of ocular complications and visual disturbances
- Sensitivity to plant compounds in the product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohammad Sadegh Bagheri Baghdasht
Tehran, 0, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 10, 2020
Study Start
August 12, 2020
Primary Completion
September 21, 2020
Study Completion
September 21, 2020
Last Updated
August 3, 2022
Record last verified: 2022-08