COVID-19NCT04445415
Diagnostic Value of New COVID-19 Antibodies Testing Among Laboratory Healthcare Workers
An observational study of COVID-19, run by Assiut University.
Trial summary
COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab testing as screening method for detection of covid 19 infections among laboratory health care workers ,assess the relationship between the infection with Covid 19 and different laboratory categories/area and assessemt of efficiency… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 antibodies testing
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Sep 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: the study was carried out using EPI info 2000 statistical package and based on a CDC COVID-19 Response Team report where the prevalence of COVID 19 infected health care workers (CDC, 2020) The minimum calculated sample was 250 health care worker , with confidence interval 80%.
Who may be able to join
- • Covid 19 infected healthcare workers.
Who cannot join
- •Risky healthcare workers (diabetic, hypertensive and more than 50 years)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Value of New- Covid 19 Antibodies Testing Among Laboratory Healthcare Workers
COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab testing as screening method for detection of covid 19 infections among laboratory health care workers ,assess the relationship between the infection with Covid 19 and different laboratory categories/area and assessemt of efficiency personal protective equipment (PPE) in different laboratory categories/area.
Read the detailed description
In December 2019, a new corona virus (CoV) emerged in China to cause an acute respiratory disease known as corona virus disease 19 (COVID-19).The virus was identified to be a betacoronavirus related to severe acute respiratory syndrome corona virus (SARS-CoV) and thus, was named SARS-CoV-2 .
New Covid-19 virus is the third known corona virus to cross the species barrier and cause severe respiratory infections in humans following SARS-CoV in 2003 and Middle East respiratory syndrome in 2012, yet with pandemic spread compared to the earlier two. In comparison, to SARS-CoV and MERS-CoV, COVID-19 virus exhibits faster human-to-human transmission.
The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th March 2020. Diagnosis of suspected cases is confirmed by molecular techniques (real-time PCR), using respiratory samples. Serology tests are easier to perform than molecular testing, but their utility may be limited by the performance and the fact that antibodies appear later during the disease course.
In the absence of a vaccine, public health authorities in several countries has shown that shutdowns can only be safely ended if a systematic "test and trace" program is put in place to control the spread of the virus which depends on the widespread availability of mass diagnostic testing.
From this point of view, detecting carriers of the virus in asymptomatic laboratory health care worker is fundamental to response efforts. It ensures the quarantine of COVID-19 patients to prevent local spread and more broadly informs national response measures.
The main route of transmission is person-to-person spread. A vulnerable cohort for infection due to frequent and close contact to COVID-19 patients are healthcare workers. To avoid patient-to-staff transmission adherence to strict hygiene standards is important. The infection with the SARS-CoV-2 usually leads to seroconversion 11-14 days after the first symptoms . However, due to asymptomatic and oligosymptomatic infections testing only symptomatic individuals can lead to a significant underestimation of the SARS-CoV-2 seroprevalence Day,.
Antibody testing is multipurpose: these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. They will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population? Only with comprehensive serology testing (and well-planned epidemiological studies) will we be able to answer these questions and reduce the ubiquitous undisclosed number in the current calculations. Several investigations are already underway in a wide variety of locations worldwide
- Conditions
- COVID-19
- Being tested
- COVID-19 antibodies testing
- 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 antibodies testingDiagnostic test
antibodies aganist COVID-19 detected in the serum of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic value of COVID-19 antibodies testing
these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
Measured: baseline
Role of COVID -19 Antibodies testing in treatment of Patients
these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons
Measured: Baseline
Assement of COVID -19 prevalence among healthcare workers
Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Salah Eldin Abdelrahman Sultan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445415
- Sponsor's protocol ID
- COVID-19 antibodies testing
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21.
PubMed 32342927Salathe M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9.
PubMed 32191813Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.
PubMed 32205334Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
PubMed 32350462
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of New- Covid 19 Antibodies Testing Among Laboratory Healthcare Workers
- ClinicalTrials.gov ID
- NCT04445415
- Acronym / sponsor ID
- COVID-19 antibodies testing
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 24 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.
COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab testing as screening method for detection of covid 19 infections among laboratory health care workers ,assess the relationship between the infection with Covid 19 and different laboratory categories/area and assessemt of efficiency personal protective equipment (PPE) in different laboratory categories/area.
Detailed description
In December 2019, a new corona virus (CoV) emerged in China to cause an acute respiratory disease known as corona virus disease 19 (COVID-19).The virus was identified to be a betacoronavirus related to severe acute respiratory syndrome corona virus (SARS-CoV) and thus, was named SARS-CoV-2 .
New Covid-19 virus is the third known corona virus to cross the species barrier and cause severe respiratory infections in humans following SARS-CoV in 2003 and Middle East respiratory syndrome in 2012, yet with pandemic spread compared to the earlier two. In comparison, to SARS-CoV and MERS-CoV, COVID-19 virus exhibits faster human-to-human transmission.
The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th March 2020. Diagnosis of suspected cases is confirmed by molecular techniques (real-time PCR), using respiratory samples. Serology tests are easier to perform than molecular testing, but their utility may be limited by the performance and the fact that antibodies appear later during the disease course.
In the absence of a vaccine, public health authorities in several countries has shown that shutdowns can only be safely ended if a systematic "test and trace" program is put in place to control the spread of the virus which depends on the widespread availability of mass diagnostic testing.
From this point of view, detecting carriers of the virus in asymptomatic laboratory health care worker is fundamental to response efforts. It ensures the quarantine of COVID-19 patients to prevent local spread and more broadly informs national response measures.
The main route of transmission is person-to-person spread. A vulnerable cohort for infection due to frequent and close contact to COVID-19 patients are healthcare workers. To avoid patient-to-staff transmission adherence to strict hygiene standards is important. The infection with the SARS-CoV-2 usually leads to seroconversion 11-14 days after the first symptoms . However, due to asymptomatic and oligosymptomatic infections testing only symptomatic individuals can lead to a significant underestimation of the SARS-CoV-2 seroprevalence Day,.
Antibody testing is multipurpose: these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. They will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population? Only with comprehensive serology testing (and well-planned epidemiological studies) will we be able to answer these questions and reduce the ubiquitous undisclosed number in the current calculations. Several investigations are already underway in a wide variety of locations worldwide
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- the study was carried out using EPI info 2000 statistical package and based on a CDC COVID-19 Response Team report where the prevalence of COVID 19 infected health care workers (CDC, 2020) The minimum calculated sample was 250 health care worker , with confidence interval 80%.
Key inclusion criteria (1 listed)
- • Covid 19 infected healthcare workers.
Key exclusion criteria (1 listed)
- •Risky healthcare workers (diabetic, hypertensive and more than 50 years)
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 antibodies testingantibodies aganist COVID-19 detected in the serum of patients | Diagnostic test | – |
Primary outcome
diagnostic value of COVID-19 antibodies testing
Time frame: baseline
these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
Role of COVID -19 Antibodies testing in treatment of Patients
Time frame: Baseline
these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons
Assement of COVID -19 prevalence among healthcare workers
Time frame: Baseline
Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Background: PubMed 32342927Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21.
- Background: PubMed 32191813Salathe M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9.
- Background: PubMed 32205334Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.
- Background: PubMed 32350462Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Salah Eldin (+201117296242, samarsalah166@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic value of COVID-19 antibodies testing (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445415, which also lists 4 linked publications.
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 24 Jun 2020.