Prospective Study on COVID -19 Reinfection on Vaccinated... | NCT06544369

Studies
Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients

NCT06544369

Sponsor

Soad Ali

Status

Completed

Last Update Posted

Aug 9, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

COVID-19 Pandemic

Interventions

COVID-19 vaccin

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

Aug 2024

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

Nov 20, 2021Actual

Primary Completion Date

Jan 18, 2022Actual

Completion Date

Jan 18, 2022Actual

First Submitted Date

Oct 25, 2021

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

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

Aug 6, 2024

Last Update Posted Date

Aug 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soad Ali, lecturer of pharmaceutics and clinical pharmacy Deraya university, Deraya UniversitySponsor-Investigator

Lead Sponsor

Soad AliOTHER

Collaborators

Not provided

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

the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.

Detailed Description

Not provided

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccinated group		all criteria are accepted for study	Biological: COVID-19 vaccin
Non-vaccinated group		all criteria are accepted for study	Biological: COVID-19 vaccin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 vaccin	Biological	injection	Non-vaccinated group Vaccinated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percent of reinfection with COVID-19 in vaccinated and non vaccinated		one year

Secondary Outcomes

Measure	Description	Time Frame
scoring of symptoms in case of reinfection in vaccinated and non vaccinated		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinically diagnosed with COVID infection
take any type of vaccines

Exclusion Criteria:

no accept sharing
not vaccinated with COVID vaccine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

the study group are infected patients with COVID-19

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Deraya university		Minya		05673	Egypt

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