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

NCT04326725 | Unknown FDA Drug

• 1 other identifier: 2020-2/1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonitis; Coronavirus Infection

Keywords

Hydroxychloroquine; coronavirus; prophylaxis; healthcare professional; outbreak

Outcome Measures

Primary Outcomes (1)

• Protection against COVID-19

  persons who took this medication should not have an infection

  4 months

Study Arms (1)

Hydroxychloroquine

Subjects with prophylaxis

Drug: Plaquenil 200Mg Tablet

Interventions

Plaquenil 200Mg Tablet DRUG

health workers under risk who took this medications

Also known as: Redoxan

Hydroxychloroquine

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• person who are working as health professional with contact to known COVID positive case
• Their first degree relatives (child, spouse or parents)
• must be able to swallow tablets

You may not qualify if:

• Already using plaquenil for other reasons (RA etc)
• person with the diagnosis of COVID infection
• Person with the condition may cause complications with this medication (severe CVD, av block, already has ophtalmological complications, organ failure of any degree etc).
• Documented allergic history to chloroquine;
• Documented history of hematological system diseases;
• Documented history of chronic liver and kidney diseases;
• Documented history of cardiac arrhythmia or chronic heart diseases;
• Documented history of retina or hearing dysfunction;
• Documented history of mental illnesses; 10. Use of digitalis due to the previous disease.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Medical School

Istanbul, 34010, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 32145363 BACKGROUND

• 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.

  PMID: 32171740 BACKGROUND

• 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.

  PMID: 32173110 BACKGROUND

• 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.

  PMID: 32074550 BACKGROUND

• 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.

  PMID: 32147628 BACKGROUND

• 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.

  PMID: 32117569 BACKGROUND

• 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.

  PMID: 32092748 BACKGROUND

• 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.

  PMID: 32139372 BACKGROUND

• 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.

  PMID: 32178711 BACKGROUND

• 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.

  PMID: 29737455 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mahir M Ozmen, Professor

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Department of Surgery

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: March 20, 2020
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

TU (1)