Clinical trial NCT04326725: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonitis
Coronavirus Infection
Keywords: Hydroxychloroquine
coronavirus
prophylaxis
healthcare professional
outbreak
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.

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.

Primary outcomes:
measure: Protection against COVID-19
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Medical School
Study officials:
affiliation: Istinye University
name: Mahir M Ozmen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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