Impact of Previous Treatment of HCV Patients by DAADs on... | NCT04729153

Studies
Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity

NCT04729153

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 3, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Covid19

Interventions

DAAD Compound

Countries

Not provided

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2021Estimated

Primary Completion Date

Feb 2022Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Jan 23, 2021

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Jan 28, 2021Actual

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

Jan 30, 2021

Last Update Posted Date

Feb 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

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

Evaluate effect of DAADs on covid-19 disease.

Detailed Description

If Chronic HCV patients who already received DAADs are protected against covid 19 and considered to be immune or not And if DAADS can be used in ttt of covid 19

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic HCV patients previously treated by DAADs.			Drug: DAAD Compound
Chronic HCV patients not treated by DAADs yet.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DAAD Compound	Drug	Sofosbuvir , Daclatasvir and ribavirin	Chronic HCV patients previously treated by DAADs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the effect of DAADs on covid -19	If chronic HCV patients who received DAADs suspected to be infected by covid-19 by having findings suggest covid 19 infection in MSCT chest or clinically symptoms or confirmed by nasopharyngeal swab . And if infected what about severity , if they need hospital admission or oxygen therapy or mechanical ventilation ,if they still alive or died	12 months (from 1/2/2021 to 1/2/2022)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCV patient with or without LC.
>18 years old.
Received DAADs at 2019.

Exclusion Criteria:

Combined HCV and HIV infected patients.
Combined HCV and HBV infected patients.
< 18 years old.
Pregnant or breast-feeding patients.
Patients with autoimmune disease.
Patients with multiorgan failure, active cancer, renal insufficiency.
Patients received immunosuppressive drugs.
Immune compromised patients.
Previous confirmed diagnosis of SARS-CoV-2 before starting DAAs.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Retrospective study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Adel	Contact	01096883754		emanadel9594@gmail.com
Nahed Ahmed	Contact	0 100 361 1626		nahedmak@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

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
C000628650	1,4-diacrylateanthracene-9,10-dione

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided