- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04466280
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Tehran, Iran, Islamisk Republik
- Mohammad Sadegh Bagheri Baghdasht
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Control Group
Participants in this group use personal protective equipment in the face of patients with COVID-19
|
Personal protective equipment such as masks, gloves, protective shields
|
Eksperimentel: Intervention Group 1
In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.
|
Personal protective equipment such as masks, gloves, protective shields
200 mg of hydroxychloroquine daily for participants in the intervention group 1
|
Eksperimentel: 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.
|
Personal protective equipment such as masks, gloves, protective shields
Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PCR test
Tidsramme: up to 1 month
|
Laboratory PCR testing can help diagnose the disease
|
up to 1 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Laboratory Treatment Response
Tidsramme: up to 1 month
|
Normal blood cell count and CRP count (normal laboratory range)
|
up to 1 month
|
drug reactions Adverse
Tidsramme: up to 1 month
|
Complications in both groups should be evaluated and evaluated during treatment.
|
up to 1 month
|
Allergic drug
Tidsramme: up to 1 month
|
There will be known allergic reactions to the drugs.
|
up to 1 month
|
Radiological Treatment Response
Tidsramme: up to 1 month
|
CT scans help determine how much the lungs are affected by COVID-19.
|
up to 1 month
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- COVID-19
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Antirheumatiske midler
- Antiprotozoale midler
- Antiparasitære midler
- Antimalariamidler
- Hydroxychloroquin
Andre undersøgelses-id-numre
- IR.BMSU.REC.1399.086
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med COVID-19
-
Yang I. PachankisAktiv, ikke rekrutterendeCOVID-19 luftvejsinfektion | COVID-19 stresssyndrom | COVID-19-vaccinebivirkning | COVID-19-associeret tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-associeret slagtilfældeKina
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbejdspartnereAfsluttetPostakutte følgesygdomme af COVID-19 | Tilstand efter COVID-19 | Langtids-COVID | Kronisk COVID-19 syndromItalien
-
Massachusetts General HospitalRekrutteringPostakut COVID-19 syndrom | Lang COVID | Postakutte følgesygdomme af COVID-19 | Lang COVID-19Forenede Stater
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRekrutteringCovid-19-pandemi | Vacciner mod covid-19 | COVID-19 virus sygdomIndonesien
-
Indonesia UniversityRekrutteringPost-COVID-19 syndrom | Lang COVID | Tilstand efter COVID-19 | Post-COVID syndrom | Lang COVID-19Indonesien
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital og andre samarbejdspartnereRekrutteringKohorteopfølgning af epidemi og neuroimaging for patienter under den første bølge af COVID-19 i KinaCOVID-19 | Post-COVID-19 syndrom | Post-akut COVID-19 | Akut COVID-19Kina
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkIkke rekrutterer endnuPost-COVID-19 syndrom | Lang COVID | Lang Covid19 | Tilstand efter COVID-19 | Post-COVID syndrom | Tilstand efter COVID-19, uspecificeret | Post-COVID tilstandHolland
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyAfsluttetPost-COVID-19 syndrom | Long-COVID-19 syndromTyskland
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRekrutteringCOVID-19 lungebetændelse | COVID-19 luftvejsinfektion | Covid-19-pandemi | COVID-19 Akut Respiratorisk Distress Syndrome | COVID-19-associeret lungebetændelse | COVID 19 associeret koagulopati | COVID-19 (Coronavirus sygdom 2019) | COVID-19-associeret tromboembolismeGrækenland
Kliniske forsøg med Personal protective equipment
-
Salisbury UniversityRekrutteringSund livsstil | Arteriel stivhedForenede Stater
-
Rambam Health Care CampusCogMe LtdRekruttering
-
The Max Stern Academic College Of Emek YezreelUkendt
-
Salisbury UniversityAfsluttetSund livsstil | Arteriel stivhedForenede Stater
-
The Hong Kong Polytechnic UniversityRekrutteringParkinsons sygdom og ParkinsonismeHong Kong
-
Global Kinetics CorporationAktiv, ikke rekrutterendeParkinsons sygdomForenede Stater
-
Mostafa ShabanTilmelding efter invitationDemens | Agitation ved demens, herunder Alzheimers sygdomEgypten
-
Kaiser PermanenteAfsluttetFedme | OvervægtigForenede Stater
-
Smiths Medical, ASD, Inc.AfsluttetPerifert intravenøst kateterCanada
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise UgandaRekrutteringStress | Velvære, psykologisk | Økonomisk nødUganda