Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Mucodentol
* Device: Personal protective equipment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Negative PCR testing through throat swabs Signing Conscious Consent Exclusion Criteria: History of ocular complications and visual disturbances Sensitivity to plant compounds in the product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Participants in this group use personal protective equipment in the face of patients with COVID-19 | Device: Personal protective equipment<br>* Personal protective equipment such as masks, gloves, protective shields<br>|
| Experimental: Intervention Group 1<br>In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment. | Drug: Hydroxychloroquine<br>* 200 mg of hydroxychloroquine daily for participants in the intervention group 1<br>Device: Personal protective equipment<br>* Personal protective equipment such as masks, gloves, protective shields<br>|
| Experimental: Intervention Group 2<br>In 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. | Drug: Mucodentol<br>* Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.<br>* Other names: Dentol Gel;Device: Personal protective equipment<br>* Personal protective equipment such as masks, gloves, protective shields<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR test | Laboratory PCR testing can help diagnose the disease | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory Treatment Response | Normal blood cell count and CRP count (normal laboratory range) | up to 1 month | 
| drug reactions Adverse | Complications in both groups should be evaluated and evaluated during treatment. | up to 1 month | 
| Allergic drug | There will be known allergic reactions to the drugs. | up to 1 month | 
| Radiological Treatment Response | CT scans help determine how much the lungs are affected by COVID-19. | up to 1 month |