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

NCT ID: NCT04466280

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2020-09-21

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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Personal protective equipment

Intervention Type DEVICE

Personal protective equipment such as masks, gloves, protective shields

Intervention Group 1

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

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

200 mg of hydroxychloroquine daily for participants in the intervention group 1

Personal protective equipment

Intervention Type DEVICE

Personal protective equipment such as masks, gloves, protective shields

Intervention Group 2

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.

Group Type EXPERIMENTAL

Mucodentol

Intervention Type DRUG

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

Intervention Type DEVICE

Personal protective equipment such as masks, gloves, protective shields

Interventions

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Hydroxychloroquine

200 mg of hydroxychloroquine daily for participants in the intervention group 1

Intervention Type DRUG

Mucodentol

Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.

Intervention Type DRUG

Personal protective equipment

Personal protective equipment such as masks, gloves, protective shields

Intervention Type DEVICE

Other Intervention Names

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Dentol Gel

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohammad Sadegh Bagheri Baghdasht

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.BMSU.REC.1399.086

Identifier Type: -

Identifier Source: org_study_id

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