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

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Hydroxychloroquine

Mucodentol

Personal protective equipment

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Mohammad Sadegh Bagheri Baghdasht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group 1

Intervention Group 2

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

PCR test

Laboratory PCR testing can help diagnose the disease

Secondary Outcome Measures

Laboratory Treatment Response

Normal blood cell count and CRP count (normal laboratory range)

drug reactions Adverse

Complications in both groups should be evaluated and evaluated during treatment.

Allergic drug

There will be known allergic reactions to the drugs.

Radiological Treatment Response

CT scans help determine how much the lungs are affected by COVID-19.

Full Information

NCT ID

NCT04466280

First Posted

July 9, 2020

Last Updated

August 2, 2022

Sponsor

Baqiyatallah Medical Sciences University

1. Study Identification

Unique Protocol Identification Number

NCT04466280

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

The financier of this research project died due to covid-19, Therefore, this project was stopped due to lack of funds

Study Start Date

August 12, 2020 (Actual)

Primary Completion Date

September 21, 2020 (Actual)

Study Completion Date

September 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intervention Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Intervention Group 2

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mucodentol

Other Intervention Name(s)

Dentol Gel

Intervention Description

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

Device

Intervention Name(s)

Personal protective equipment

Intervention Description

Personal protective equipment such as masks, gloves, protective shields

Primary Outcome Measure Information:

Title

PCR test

Description

Laboratory PCR testing can help diagnose the disease

Time Frame

up to 1 month

Secondary Outcome Measure Information:

Title

Laboratory Treatment Response

Description

Normal blood cell count and CRP count (normal laboratory range)

Time Frame

up to 1 month

Title

drug reactions Adverse

Description

Complications in both groups should be evaluated and evaluated during treatment.

Time Frame

up to 1 month

Title

Allergic drug

Description

There will be known allergic reactions to the drugs.

Time Frame

up to 1 month

Title

Radiological Treatment Response

Description

CT scans help determine how much the lungs are affected by COVID-19.

Time Frame

up to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Mohammad Sadegh Bagheri Baghdasht

City

Tehran

ZIP/Postal Code

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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