Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc Dur... | NCT04326725

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

NCT04326725

Sponsor

Istinye University

Status

Unknown status

Last Update Posted

Jul 28, 2020Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Pneumonitis
Coronavirus Infection

Interventions

Plaquenil 200Mg Tablet

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2020Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Mar 26, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydroxychloroquine		Subjects with prophylaxis	Drug: Plaquenil 200Mg Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plaquenil 200Mg Tablet	Drug	health workers under risk who took this medications	Hydroxychloroquine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Protection against COVID-19	persons who took this medication should not have an infection	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahir M Ozmen, Professor	Istinye University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istinye University Medical School		Istanbul		34010	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32145363	Background	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.
32171740	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.

ID	Term
D011014	Pneumonia
D018352	Coronavirus Infections

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring