COVID-19 Antibodies Among Healthcare Workers | NCT04425889

Studies
COVID-19 Antibodies Among Healthcare Workers

NCT04425889

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Status

Completed

Last Update Posted

Jun 12, 2020Actual

Enrollment

156Actual

Phase

Not provided

Conditions

COVID-19
SARS-CoV 2

Interventions

COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)

Countries

Mexico

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

Jun 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 5, 2020Actual

Primary Completion Date

May 30, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jun 6, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 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

Jun 10, 2020

Last Update Posted Date

Jun 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Adrian Camacho-Ortiz, Head of infectious diseases, Hospital Universitario Dr. Jose E. GonzalezPrincipal Investigator

Lead Sponsor

Hospital Universitario Dr. Jose E. GonzalezOTHER

Collaborators

Not provided

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

Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

Detailed Description

All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

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

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exposed Healthcare workers		Healthcare workers working for 8 weeks in a COVID-19 area	Diagnostic Test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)	Diagnostic Test	a blood sample is drained for detection of IgG and IgM antibody	exposed Healthcare workers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of antibody	presence of IgG and/or IgM against SARS-CoV-2	through study completion, an average of 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All healthcare workers who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance were included

Exclusion Criteria:

Healthcare workers who did not have exposure for more or equal 14 days
Healthcare workers who did not wish to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Healthcare workes of any category that are 18 years of age or older, who work in the COVID-19 unit at the University Hospital and hve been diagnosing and treating suspected or confirmed cases of COVID-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario José E. Gonzalez		Monterrey	Nuevo León	64460	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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