Novel Regimens in COVID-19 Treatment | NCT04382846

Studies
Novel Regimens in COVID-19 Treatment

NCT04382846

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Dec 4, 2020Actual

Enrollment

160Estimated

Phase

Phase 3

Conditions

COVID
Corona Virus Infection

Interventions

Nitazoxanide

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2020Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 1, 2030Estimated

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 11, 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

Dec 2, 2020

Last Update Posted Date

Dec 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

Detailed Description

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019. Some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitazoxanide	Experimental	Nitazoxanide with standard protocol of treatment	Drug: Nitazoxanide
Control group	No Intervention	Standard protocol alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	Nitazoxanide	Nitazoxanide	Parazoxanide, Nanazoxid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with virological cure	the number of patients with virological cure	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with COVID-19 infection

Exclusion Criteria:

Allergy or contraindication to the drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
sherief Abd-Elsalam, Ass. Prof.	ass. Prof. Tropical Medicine	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32360581	Background	Kelleni MT. Nitazoxanide/azithromycin combination for COVID-19: A suggested new protocol for early management. Pharmacol Res. 2020 Jul;157:104874. doi: 10.1016/j.phrs.2020.104874. Epub 2020 Apr 30.
32322397	Background	Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases