Immunologic Activity AlterationNCT04354792
Asymptomatic COVID-19 Infection Among Healthcare Workers
An observational study of Immunologic Activity Alteration, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunologic Activity Alteration
- What is being tested?
- Serum SARs COV 2 IGg screening in health care workers
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 10 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.
Who may be able to join
- Age: From 25 to 60 years old
- Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.
Who cannot join
- pregnant
- Age over 60 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.
To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals
Read the detailed description
The proposed study is a cross sectional study that will be carried out among HCWs in three University hospitals namely Kasr Alaini , Ain Shams , and Zagazeg Hospitals, employing a quantitative survey.
II-Study population Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.
Inclusion criteria Age: From 25 to 60 years old Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.
The potential participants will be given an information sheet and time to review this information before informed consent is sought. After the potential participants have agreed to be enrolled in the study, an informed consent will be obtained by the Investigator.
III- Procedures and Data collection:
Serum Collection and Interview A- Detecting Serum IgG against SARS-CoV2
Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization.(5) The sensitivity and specificity reported by the manufacturer for IgM are 88.2% and 99.0% respectively, and for IgG are 97.8% and 97.9%.
B- Structured Interview questionnaire
A structured - interview questionnaire using closed ended question format will be used to obtain information on:
- Socio-demographic characteristics of the interviewees asking about age, sex, residence, education, occupation, department, Job title, hospital name, medical experience in years, marital status, living with family, and having children or not.
- History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),
- The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.
- In addition, information will be collected regarding any clinical signs or symptoms in the worker past 3 months, including fever, cough, shortness of breath, or radiographically confirmed pneumonia.
- Conditions
- Immunologic Activity Alteration
- Being tested
- Serum SARs COV 2 IGg screening in health care workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum SARs COV 2 IGg screening in health care workersDiagnostic test
Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IGg seropositive health care workers
health care workers who have positive IGg in seum
Measured: single measurement from each person collected over 2 months
Secondary outcomes (1)
Differentiation between low risk and high risk HCWs
to know positive IGg persons and IGg negative persons to understand risk factors
Measured: 2 months through out duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immunologic Activity AlterationStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mukhtar, Kasr El Aini Hospital
- Investigators
- Ahmed M Mukhtar, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354792
- Sponsor's protocol ID
- N-31-2020
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
PubMed 32183930
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT04354792
- Acronym / sponsor ID
- N-31-2020
- Conditions
- Immunologic Activity Alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 21 Apr 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.
To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals
Detailed description
The proposed study is a cross sectional study that will be carried out among HCWs in three University hospitals namely Kasr Alaini , Ain Shams , and Zagazeg Hospitals, employing a quantitative survey.
II-Study population Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.
Inclusion criteria Age: From 25 to 60 years old Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.
The potential participants will be given an information sheet and time to review this information before informed consent is sought. After the potential participants have agreed to be enrolled in the study, an informed consent will be obtained by the Investigator.
III- Procedures and Data collection:
Serum Collection and Interview A- Detecting Serum IgG against SARS-CoV2
Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization.(5) The sensitivity and specificity reported by the manufacturer for IgM are 88.2% and 99.0% respectively, and for IgG are 97.8% and 97.9%.
B- Structured Interview questionnaire
A structured - interview questionnaire using closed ended question format will be used to obtain information on:
- Socio-demographic characteristics of the interviewees asking about age, sex, residence, education, occupation, department, Job title, hospital name, medical experience in years, marital status, living with family, and having children or not.
- History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),
- The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.
- In addition, information will be collected regarding any clinical signs or symptoms in the worker past 3 months, including fever, cough, shortness of breath, or radiographically confirmed pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.
Key inclusion criteria (2 listed)
- Age: From 25 to 60 years old
- Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.
Key exclusion criteria (2 listed)
- pregnant
- Age over 60 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 |
|---|---|---|
| Serum SARs COV 2 IGg screening in health care workersBlood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization | Diagnostic test | – |
Primary outcome
Number of IGg seropositive health care workers
Time frame: single measurement from each person collected over 2 months
health care workers who have positive IGg in seum
1 secondary outcome
Differentiation between low risk and high risk HCWs
Time frame: 2 months through out duration of study
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 17 Jun 2020.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32183930Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
- Individual participant dataSharing planned: No
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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.
Ahmed M Mukhtar, M.D principal investigator
Cairo University
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 Immunologic Activity Alteration, run by Kasr El Aini Hospital at 1 site in Egypt.
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 2 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 17 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 Egypt. 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?
Number of IGg seropositive health care workers (time frame: single measurement from each person collected over 2 months). 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 NCT04354792, which also lists 2 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 17 Jun 2020.