Covid19NCT04605952
Study to Find the Percentage of Cases Retaining COVID-19 IgG Antibodies 45-65 After They Have Tested Positive
An observational study of Covid19, run by Tata Main Hospital at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Repeat SARS-CoV-2 IgG antibodies at 45-65 days
- How many people
- 201 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2020to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Asymptomatic workforce
Who may be able to join
- SARS-CoV-2 IgG antibody positive between 28th June and 15th July 2020
Who cannot join
- SARS-CoV-2 IgG antibody negative between 28th June and 15th July 2020
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
As a serosurveillance measure, 3296 asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for COVID-19 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.
The cases who tested positive for COVID-19 IgG antibodies were repeat tested for the presence of COVID-19 IgG at 45-65 days after initially testing positive. This was done with the aim of finding out the percentage of cases retaining their IgG antibodies at 45-65 days of initially testing positive.
- Conditions
- Covid19
- Being tested
- Repeat SARS-CoV-2 IgG antibodies at 45-65 days
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Repeat SARS-CoV-2 IgG antibodies at 45-65 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45-65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Jul 2020
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Main Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Deb Sanjay Nag, Tata Main Hospital
- Investigators
- DR.DEB S NAG, MD, Principal investigator, Tata Main Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605952
- Sponsor's protocol ID
- 152473
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Find the Percentage of Cases Retaining COVID-19 IgG Antibodies 45-65 After They Have Tested Positive
- ClinicalTrials.gov ID
- NCT04605952
- Acronym / sponsor ID
- 152473
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Tata Main HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As a serosurveillance measure, 3296 asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for COVID-19 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.
The cases who tested positive for COVID-19 IgG antibodies were repeat tested for the presence of COVID-19 IgG at 45-65 days after initially testing positive. This was done with the aim of finding out the percentage of cases retaining their IgG antibodies at 45-65 days of initially testing positive.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 IgG antibody positive between 28th June to 15th July 2020 | – | Diagnostic Test: Repeat SARS-CoV-2 IgG antibodies at 45-65 daysAs 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asymptomatic workforce
Key inclusion criteria (1 listed)
- SARS-CoV-2 IgG antibody positive between 28th June and 15th July 2020
Key exclusion criteria (1 listed)
- SARS-CoV-2 IgG antibody negative between 28th June and 15th July 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeat SARS-CoV-2 IgG antibodies at 45-65 daysAll cases who initially tested positive for SARS-CoV-2 IgG antibodies would undergo a repeat test at 45-65 days | Diagnostic test | SARS-CoV-2 IgG antibody positive between 28th June to 15th July 2020 |
Primary outcome
Percentage of cases retaining SARS-CoV-2 IgG antibodies at 45-65 days
Time frame: 45-65 days
Percentage of cases retaining SARS-CoV-2 IgG antibodies at 45-65 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR.DEB S NAG, MD principal investigator
Tata Main Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Tata Main Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cases retaining SARS-CoV-2 IgG antibodies at 45-65 days (time frame: 45-65 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.