Efficacay of Chloroquine or Hydroxychloroquine in COVID-1... | NCT04353336

Studies
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

NCT04353336

Sponsor

Tanta University

Status

Completed

Last Update Posted

Aug 2, 2021Actual

Enrollment

194Actual

Phase

Phase 2Phase 3

Conditions

COVID-19
Coronavirus Infection

Interventions

Chloroquine or Hydroxychloroquine

Countries

Egypt

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2020Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 20, 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 29, 2021

Last Update Posted Date

Aug 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chloroquine or hydroxychloroquine in COVID-19 treatment

Detailed Description

Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chloroquine or Hydroxychloroquine	Experimental	Chloroquine or Hydroxychloroquine with standard of care treatment.	Drug: Chloroquine or Hydroxychloroquine
No intervention	No Intervention	standard of care treatment alone.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroquine or Hydroxychloroquine	Drug	Chloroquine or Hydroxychloroquine	Chloroquine or Hydroxychloroquine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with cure or death	the number of patients with cure or death	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Covid 19 patients

Exclusion Criteria:

Allergy or contraindication to the drug
Pregnant or lactating
Patients with cardiac problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sherief Abd-Elsalam, Ass. Prof.	Tanta University - Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University, Assiut University		Tanta		35111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002738	Chloroquine
D006886	Hydroxychloroquine

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided