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

Baqiyatallah Medical Sciences University

Status: Withdrawn

Conditions: COVID-19

Treatments: Drug: Hydroxychloroquine; Drug: Mucodentol; Device: Personal protective equipment

Study type: Interventional

Funder types: Other

Identifiers

NCT04466280

IR.BMSU.REC.1399.086

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Participants in this group use personal protective equipment in the face of patients with COVID-19

Treatment:

Device: Personal protective equipment

Intervention Group 1

Experimental group

Description:

In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.

Treatment:

Drug: Hydroxychloroquine

Device: Personal protective equipment

Intervention Group 2

Experimental group

Description:

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.

Treatment:

Drug: Mucodentol

Device: Personal protective equipment