COVID-19NCT04466280
Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19
A study testing Hydroxychloroquine, Mucodentol and Personal protective equipment in people with COVID-19, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine, Mucodentol and Personal protective equipment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIran
- Study dates
- 12 Aug 2020to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Negative PCR testing through throat swabs
- Signing Conscious Consent
Who cannot join
- History of ocular complications and visual disturbances
- Sensitivity to plant compounds in the product
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Mucodentol, Personal protective equipment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg of hydroxychloroquine daily for participants in the intervention group 1
MucodentolDrug
Also called Dentol Gel
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 equipmentDevice
Personal protective equipment such as masks, gloves, protective shields
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in this group use personal protective equipment in the face of patients with COVID-19 Receives: Device: Personal protective equipment |
| Intervention Group 1 | Experimental | In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment. Receives: Drug: Hydroxychloroquine; Device: Personal protective equipment |
| Intervention Group 2 | Experimental | 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. Receives: Drug: Mucodentol; Device: Personal protective equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR test
Laboratory PCR testing can help diagnose the disease
Measured: up to 1 month
Secondary outcomes (4)
Laboratory Treatment Response
Normal blood cell count and CRP count (normal laboratory range)
Measured: up to 1 month
drug reactions Adverse
Complications in both groups should be evaluated and evaluated during treatment.
Measured: up to 1 month
Allergic drug
There will be known allergic reactions to the drugs.
Measured: up to 1 month
Radiological Treatment Response
CT scans help determine how much the lungs are affected by COVID-19.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start12 Aug 2020
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Why it stopped: The financier of this research project died due to covid-19, Therefore, this project was stopped due to lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466280
- Sponsor's protocol ID
- IR.BMSU.REC.1399.086
- Status last verified
- Aug 2022
- First submitted
- 9 Jul 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04466280
- Acronym / sponsor ID
- IR.BMSU.REC.1399.086
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The financier of this research project died due to covid-19, Therefore, this project was stopped due to lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Personal protective equipmentParticipants in this group use personal protective equipment in the face of patients with COVID-19 |
| Intervention Group 1 | Experimental | Drug: Hydroxychloroquine, Device: Personal protective equipmentIn this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment. |
| Intervention Group 2 | Experimental | Drug: Mucodentol, Device: Personal protective equipmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Negative PCR testing through throat swabs
- Signing Conscious Consent
Key exclusion criteria (2 listed)
- History of ocular complications and visual disturbances
- Sensitivity to plant compounds in the product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine200 mg of hydroxychloroquine daily for participants in the intervention group 1 | Drug | Intervention Group 1 |
| MucodentolAlso: Dentol GelIntervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours. | Drug | Intervention Group 2 |
| Personal protective equipmentPersonal protective equipment such as masks, gloves, protective shields | Device | Control Group, Intervention Group 1, Intervention Group 2 |
Primary outcome
PCR test
Time frame: up to 1 month
Laboratory PCR testing can help diagnose the disease
4 secondary outcomes
Laboratory Treatment Response
Time frame: up to 1 month
drug reactions Adverse
Time frame: up to 1 month
Allergic drug
Time frame: up to 1 month
Radiological Treatment Response
Time frame: up to 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine, Mucodentol and Personal protective equipment in people with COVID-19, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR test (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.