Efficacy of Faviprevir in COVID-19 Treatment | NCT04351295

Studies
Efficacy of Faviprevir in COVID-19 Treatment

NCT04351295

Sponsor

Tanta University

Status

Completed

Last Update Posted

Nov 1, 2021Actual

Enrollment

92Actual

Phase

Phase 2Phase 3

Conditions

COVID

Interventions

Favipiravir
Chloroquine

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

Oct 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

Apr 20, 2020Actual

Primary Completion Date

Sep 28, 2020Actual

Completion Date

Sep 28, 2020Actual

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 17, 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

Oct 29, 2021

Last Update Posted Date

Nov 1, 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

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Faviprevir	Experimental	Faviprevir	Drug: Favipiravir
chloroquine	Active Comparator	chloroquine	Drug: Chloroquine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Favipiravir	Drug	Favipiravir	Faviprevir	Faviprevir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with mortality or need for mechanical ventilation	Number of patients with mortality or need for mechanical ventilation	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with covid 19

Exclusion Criteria:

Allergy or contraindications to faviprevir

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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, Ainshams University		Tanta		35111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33492523	Derived	Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.	34811571Arch Virol. 2022 Jan;167(1):277

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