NCT04605952

Brief Summary

As a serosurveillance measure asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for COVID-19 IgG antibodies. Of the tested employees who were positive for COVID-19 IgG antibodies the study aimed to find the percentage of cases who retained their COVID-19 IgG antibodies 45-65 days after initially testing positive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

July 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 23, 2020

Last Update Submit

October 27, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Percentage of cases retaining SARS-CoV-2 IgG antibodies at 45-65 days

    Percentage of cases retaining SARS-CoV-2 IgG antibodies at 45-65 days

    45-65 days

Study Arms (1)

SARS-CoV-2 IgG antibody positive between 28th June to 15th July 2020

As a serosurveillance measure, 3296 asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for SARS-CoV-2 IgG antibodies specific for the spike subunit antigen by the ErbaLisa COVID-19, Erba Corporate Services (United Kingdom) between 28th June and 15th July 2020. All those who initially tested SARS-CoV-2 IgG antibody positive were retested at 45-65 days

Diagnostic Test: Repeat SARS-CoV-2 IgG antibodies at 45-65 days

Interventions

Repeat SARS-CoV-2 IgG antibodies at 45-65 daysDIAGNOSTIC_TEST

All cases who initially tested positive for SARS-CoV-2 IgG antibodies would undergo a repeat test at 45-65 days

SARS-CoV-2 IgG antibody positive between 28th June to 15th July 2020

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Asymptomatic workforce

You may qualify if:

  • SARS-CoV-2 IgG antibody positive between 28th June and 15th July 2020

You may not qualify if:

  • SARS-CoV-2 IgG antibody negative between 28th June and 15th July 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, 831011, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • DR.DEB S NAG, MD

    Tata Main Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Tata Main Hospital

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 28, 2020

Study Start

July 1, 2020

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)