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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Device: Personal protective equipment; Drug: Hydroxychloroquine; Drug: Mucodentol

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Mohammad Sadegh Bagheri Baghdasht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in this group use personal protective equipment in the face of patients with COVID-19	Device: Personal protective equipment; Personal protective equipment such as masks, gloves, protective shields
Experimental: Intervention Group 1; In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.	Device: Personal protective equipment; Personal protective equipment such as masks, gloves, protective shields; Drug: Hydroxychloroquine; 200 mg of hydroxychloroquine daily for participants in the intervention group 1
Experimental: 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.	Device: Personal protective equipment; Personal protective equipment such as masks, gloves, protective shields; 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.; Other Names: Dentol Gel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: IR.BMSU.REC.1399.086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No