Covid19cov prevalenceNCT04941053
Seroprevalence of COVID-19
An observational study of Covid19, run by Sohag University at 1 site in Egypt.
Trial summary
Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- laboratory test
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2021to 30 Dec 2021
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: group 1 patients coming to hemodialysis unit group 2 relative to patients coming to hemodialysis unit, medical staff
Who may be able to join
- patient accept to participate
Who cannot join
- vaccinated people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of COVID19 in Sohag Governorate Egypt
Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Around 70% to 90% of a population needs to be immune to protect the uninfected. In A Spanish study of more than 30,000 people estimates that around just 5% of the Spanish population has developed antibodies
Read the detailed description
Aims of work:
A cross-sectional study to detect the seroprevalence to COVID 19 in chronic hemodialysis patients and compare it with the COVID 19 seroprevalence in healthy control in Sohag governorate Egypt
Methods:
After taken informed consent according to Sohag University Ethical Committee A questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous COVID 19 infection and infection control measures to prevent it
5 ml of the blood sample will be taken for IgG antibodies testing with a chemiluminescent microparticle immunoassay.
- Conditions
- Covid19
- Being tested
- laboratory test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testDiagnostic test
seroprevalnce
| Study group | Role | What they receive |
|---|---|---|
| group 1 chronic haemodialysis patients | seroprevalnce of COVID 19 Receives: Diagnostic Test: laboratory test | |
| healthy control | seroprevalnce of COVID 19 Receives: Diagnostic Test: laboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprevalnce
antibody measurement
Measured: 3-6-2021 to 30-8-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start3 Jun 2021
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
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.
- More trials run by Sohag 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- N S shafik, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941053
- Sponsor's protocol ID
- Soh-Med-21-04-33
- Acronym
- cov prevalence
- Status last verified
- Oct 2022
- First submitted
- 23 Jun 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to protect privacy of data of patients
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of COVID19 in Sohag Governorate Egypt
- ClinicalTrials.gov ID
- NCT04941053
- Acronym / sponsor ID
- cov prevalence / Soh-Med-21-04-33
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Jun 2021 (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.
Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Around 70% to 90% of a population needs to be immune to protect the uninfected. In A Spanish study of more than 30,000 people estimates that around just 5% of the Spanish population has developed antibodies
Detailed description
Aims of work:
A cross-sectional study to detect the seroprevalence to COVID 19 in chronic hemodialysis patients and compare it with the COVID 19 seroprevalence in healthy control in Sohag governorate Egypt
Methods:
After taken informed consent according to Sohag University Ethical Committee A questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous COVID 19 infection and infection control measures to prevent it
5 ml of the blood sample will be taken for IgG antibodies testing with a chemiluminescent microparticle immunoassay.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 chronic haemodialysis patients | – | Diagnostic Test: laboratory testseroprevalnce of COVID 19 |
| healthy control | – | Diagnostic Test: laboratory testseroprevalnce of COVID 19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- group 1 patients coming to hemodialysis unit group 2 relative to patients coming to hemodialysis unit, medical staff
Key inclusion criteria (1 listed)
- patient accept to participate
Key exclusion criteria (1 listed)
- vaccinated people
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 |
|---|---|---|
| laboratory testseroprevalnce | Diagnostic test | group 1 chronic haemodialysis patients, healthy control |
Primary outcome
seroprevalnce
Time frame: 3-6-2021 to 30-8-2021
antibody measurement
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 25 Oct 2022.
- Individual participant dataSharing planned: No. to protect privacy of data of patients
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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.
N S shafik, lecturer principal investigator
Sohag 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 Covid19, run by Sohag University 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 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 25 Oct 2022. 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?
seroprevalnce (time frame: 3-6-2021 to 30-8-2021). 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 25 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.