NCT04425889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

25 days

First QC Date

June 6, 2020

Last Update Submit

June 10, 2020

Conditions

COVID-19SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

  • Presence of antibody

    presence of IgG and/or IgM against SARS-CoV-2

    through study completion, an average of 8 weeks

Study Arms (1)

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

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of infectious diseases

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 11, 2020

Study Start

May 5, 2020

Primary Completion

May 30, 2020

Study Completion

June 1, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

ME(1)