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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326725
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Mahir Ozmen, Istinye University

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
Pneumonitis Coronavirus Infection 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.

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Study Type : Observational
Estimated 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 : March 20, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020


Group/Cohort Intervention/treatment
Hydroxychloroquine
Subjects with prophylaxis
Drug: Plaquenil 200Mg Tablet
health workers under risk who took this medications
Other Name: Redoxan




Primary Outcome Measures :
  1. Protection against COVID-19 [ Time Frame: 4 months ]
    persons who took this medication should not have an infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Mainly doctors, nurses, health workers in the hospital whereby they have close contacts with possile COVID-19 infected patients were included. Their first degree relatives(spouse, child, parents)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326725


Contacts
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Contact: Mahir M Ozmen, Professor +905324246838 ozmenmm@gmail.com

Locations
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Turkey
Istinye University Medical School Recruiting
Istanbul, Turkey, 34010
Contact: Istinye University M ozmen, Prof    +905324246838    mahir.ozmen@istinye.edu.tr   
Sponsors and Collaborators
Istinye University
Publications:

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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: March 30, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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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, Istinye University:
Hydroxychloroquine
coronavirus
prophylaxis
healthcare professional
outbreak
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents