COVID-19NCT04425889
COVID-19 Antibodies Among Healthcare Workers
An observational study of COVID-19 and SARS-CoV 2, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)
- How many people
- 156 participants
- Where
- 1 siteMexico
- Study dates
- 5 May 2020to 1 Jun 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Healthcare workers who did not have exposure for more or equal 14 days
- Healthcare workers who did not wish to participate
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit
Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody
Read the 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.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| exposed Healthcare workers | Healthcare workers working for 8 weeks in a COVID-19 area Receives: Diagnostic Test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of antibody
presence of IgG and/or IgM against SARS-CoV-2
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start5 May 2020
- Primary completion30 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425889
- Sponsor's protocol ID
- IF20-00008
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit
- ClinicalTrials.gov ID
- NCT04425889
- Acronym / sponsor ID
- IF20-00008
- Conditions
- COVID-19, SARS-CoV 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 11 Jun 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exposed Healthcare workers | – | Diagnostic Test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)Healthcare workers working for 8 weeks in a COVID-19 area |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Healthcare workers who did not have exposure for more or equal 14 days
- Healthcare workers who did not wish to participate
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 |
|---|---|---|
| COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)a blood sample is drained for detection of IgG and IgM antibody | Diagnostic test | exposed Healthcare workers |
Primary outcome
Presence of antibody
Time frame: through study completion, an average of 8 weeks
presence of IgG and/or IgM against SARS-CoV-2
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 12 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and SARS-CoV 2, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 2 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 12 Jun 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 Mexico. 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?
Presence of antibody (time frame: through study completion, an average of 8 weeks). 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 12 Jun 2020.