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

Coronavirus Infection Clinical Trial

Official title:

Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins C, D and Zinc During COVID-19 Pandemia: An Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04326725
• Other study ID #: 2020-2/1
• Status: Active, not recruiting
• Start date: March 20, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2020
• Source: Istinye University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Pneumonia
• Pneumonitis
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Istinye University Medical School	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Apr;55(4):105932. doi: 10.1016/j.ijantimicag.2020.105932. Epub 2020 Mar 4. — View Citation

Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10. — View Citation

Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6. — View Citation

Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12. — View Citation

Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov Ther. 2020;14(1):58-60. doi: 10.5582/ddt.2020.01012. — View Citation

Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19. — View Citation

Kruse RL. Therapeutic strategies in an outbreak scenario to treat the novel coronavirus originating in Wuhan, China. F1000Res. 2020 Jan 31;9:72. doi: 10.12688/f1000research.22211.2. eCollection 2020. Review. — View Citation

Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5. Review. — View Citation

Plantone D, Koudriavtseva T. Current and Future Use of Chloroquine and Hydroxychloroquine in Infectious, Immune, Neoplastic, and Neurological Diseases: A Mini-Review. Clin Drug Investig. 2018 Aug;38(8):653-671. doi: 10.1007/s40261-018-0656-y. Review. — View Citation

Song P, Karako T. COVID-19: Real-time dissemination of scientific information to fight a public health emergency of international concern. Biosci Trends. 2020 Mar 16;14(1):1-2. doi: 10.5582/bst.2020.01056. Epub 2020 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protection against COVID-19	persons who took this medication should not have an infection	4 months