Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326725
Recruitment Status : Active, not recruiting
First Posted : March 30, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Mahir Ozmen, Istinye University

Tracking Information
First Submitted Date March 26, 2020
First Posted Date March 30, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date March 20, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2020)
Protection against COVID-19 [ Time Frame: 4 months ]
persons who took this medication should not have an infection
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia
Official Title Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins C, D and Zinc During COVID-19 Pandemia: An Observational Study
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Pneumonitis
  • Coronavirus Infection
Intervention Drug: Plaquenil 200Mg Tablet
health workers under risk who took this medications
Other Name: Redoxan
Study Groups/Cohorts Hydroxychloroquine
Subjects with prophylaxis
Intervention: Drug: Plaquenil 200Mg Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 27, 2020)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04326725
Other Study ID Numbers 2020-2/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Mehmet Mahir Ozmen, Istinye University
Study Sponsor Istinye University
Collaborators Not Provided
Investigators
Principal Investigator: Mahir M Ozmen, Professor Istinye University
PRS Account Istinye University
Verification Date July 2020