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Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia

Sponsor
Istinye University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04326725
Collaborator
(none)
80
Enrollment
1
Location
5.4
Anticipated Duration (Months)
14.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.

Condition or Disease Intervention/Treatment Phase
  • Drug: Plaquenil 200Mg Tablet

Detailed Description

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients.PArticipants, age, sex, BMI, smoking history, comorbid disease were also registered.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins C, D and Zinc During COVID-19 Pandemia: An Observational Study
Actual Study Start Date :
Mar 20, 2020
Actual Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Hydroxychloroquine

Subjects with prophylaxis

Drug: Plaquenil 200Mg Tablet
health workers under risk who took this medications
Other Names:
  • Redoxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Protection against COVID-19 [4 months]

      persons who took this medication should not have an infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. person who are working as health professional with contact to known COVID positive case

    2. Their first degree relatives (child, spouse or parents)

    3. must be able to swallow tablets

    Exclusion Criteria:

    1. Already using plaquenil for other reasons (RA etc)

    2. person with the diagnosis of COVID infection

    3. Person with the condition may cause complications with this medication (severe CVD, av block, already has ophtalmological complications, organ failure of any degree etc).

    4. Documented allergic history to chloroquine;

    5. Documented history of hematological system diseases;

    6. Documented history of chronic liver and kidney diseases;

    7. Documented history of cardiac arrhythmia or chronic heart diseases;

    8. Documented history of retina or hearing dysfunction;

    9. Documented history of mental illnesses; 10. Use of digitalis due to the previous disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istinye University Medical School Istanbul Turkey 34010

    Sponsors and Collaborators

    • Istinye University

    Investigators

    • Principal Investigator: Mahir M Ozmen, Professor, Istinye University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mehmet Mahir Ozmen, Professor of Surgery, Department of Surgery, Istinye University
    ClinicalTrials.gov Identifier:
    NCT04326725
    Other Study ID Numbers:
    • 2020-2/1
    First Posted:
    Mar 30, 2020
    Last Update Posted:
    Jul 28, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Mehmet Mahir Ozmen, Professor of Surgery, Department of Surgery, Istinye University
    Hydroxychloroquine
    coronavirus
    prophylaxis
    healthcare professional
    outbreak
    Additional relevant MeSH terms:
    Coronavirus Infections
    Pneumonia
    Hydroxychloroquine

    Study Results

    No Results Posted as of Jul 28, 2020