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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04466280
• Other study ID #: IR.BMSU.REC.1399.086
• Status: Withdrawn
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: September 21, 2020

Study information

• Verified date: August 2022
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
200 mg of hydroxychloroquine daily for participants in the intervention group 1
• 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.

Device:
• Personal protective equipment
Personal protective equipment such as masks, gloves, protective shields

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR test	Laboratory PCR testing can help diagnose the disease	up to 1 month
Secondary	Laboratory Treatment Response	Normal blood cell count and CRP count (normal laboratory range)	up to 1 month
Secondary	drug reactions Adverse	Complications in both groups should be evaluated and evaluated during treatment.	up to 1 month
Secondary	Allergic drug	There will be known allergic reactions to the drugs.	up to 1 month
Secondary	Radiological Treatment Response	CT scans help determine how much the lungs are affected by COVID-19.	up to 1 month