Immune Response to Covid-19 in 300 Health Care Workers Wi... | NCT04356586

Studies
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms

NCT04356586

Sponsor

Sciensano

Status

Completed

Last Update Posted

Sep 7, 2020Actual

Enrollment

287Actual

Phase

Not provided

Conditions

COVID-19
Serology

Interventions

Not provided

Countries

Belgium

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

Sep 2020

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

May 4, 2020Actual

Primary Completion Date

Aug 21, 2020Actual

Completion Date

Aug 21, 2020Actual

First Submitted Date

Apr 17, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 22, 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

Sep 4, 2020

Last Update Posted Date

Sep 7, 2020Actual

Name	Class
Jessa Hospital	OTHER

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

Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.

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

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of serological positive healthcare workers		three months
Percentage of HCW with positive Saliva-sabs		three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

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

HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Goossens, MD, PhD	Sciensano	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sciensano		Brussels		1050	Belgium

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided