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

NCT ID: NCT04326725

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Pneumonitis Coronavirus Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hydroxychloroquine

Subjects with prophylaxis

Plaquenil 200Mg Tablet

Intervention Type DRUG

health workers under risk who took this medications

Interventions

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Plaquenil 200Mg Tablet

health workers under risk who took this medications

Intervention Type DRUG

Other Intervention Names

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Redoxan

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Mahir Ozmen

Professor of Surgery, Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahir M Ozmen, Professor

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Locations

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Istinye University Medical School

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 32145363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32171740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32173110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32074550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32147628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32117569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32092748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32139372 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32178711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29737455 (View on PubMed)

Other Identifiers

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2020-2/1

Identifier Type: -

Identifier Source: org_study_id

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