COVIDNCT04424017
Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers
An observational study of COVID and Corona Virus Infection, run by Egyptian Center for Research and Regenerative Medicine at 2 sites in Egypt.
Trial summary
The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID, Corona Virus Infection
- What is being tested?
- Specific anti-SARS-CoV-2 antibodies
- How many people
- 1,546 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 Jun 2020to 30 Oct 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
- No healthy volunteers
- Adult
Study population: Age-stratified sample from general population with 3 subgroups: 1. Healthcare workers (HCWs), comprising frontline doctors, nurses, health attendants, and receptionists. 2. Healthy blood donors and healthy subjects in blood bank or laboratory (routine examinations as pre-employment, likely to be representative of the general population 3. Convalescents
Who may be able to join
- Not previously diagnosed with COVID-19 except for convalescents
- Not currently symptomatic with fever or respiratory symptoms (cough, dyspnea)
Who cannot join
- Patients with fever or respiratory symptoms (cough, dyspnea)
- Refusal to give informed consent, or contraindication to venipuncture.
Trial locations and contacts
2 sites in 1 country.
About this study
The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.
- Conditions
- COVID, Corona Virus Infection
- Being tested
- Specific anti-SARS-CoV-2 antibodies
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific anti-SARS-CoV-2 antibodiesBiological
A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.
All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers (HCWs) | Not described Receives: Biological: Specific anti-SARS-CoV-2 antibodies | |
| Healthy blood donors and healthy subjects in blood bank | Not described Receives: Biological: Specific anti-SARS-CoV-2 antibodies | |
| Convalescents | Not described Receives: Biological: Specific anti-SARS-CoV-2 antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start7 Jun 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Center for Research and Regenerative Medicine
- Sponsor type
- Other government
- Collaborators
- Cairo University, National Research Centre, Egypt, Academy of Scientific Research and Technology, Egypt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424017
- Sponsor's protocol ID
- COVID-19\004
- Status last verified
- Mar 2021
- First submitted
- 8 Jun 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers
- ClinicalTrials.gov ID
- NCT04424017
- Acronym / sponsor ID
- COVID-19\004
- Conditions
- COVID, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,546 participants (actual)
- Lead sponsor
- Egyptian Center for Research and Regenerative MedicineOther government
- Collaborators
- Cairo University, National Research Centre, Egypt, Academy of Scientific Research and Technology, Egypt
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 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.
The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers (HCWs) | – | Biological: Specific anti-SARS-CoV-2 antibodies |
| Healthy blood donors and healthy subjects in blood bank | – | Biological: Specific anti-SARS-CoV-2 antibodies |
| Convalescents | – | Biological: Specific anti-SARS-CoV-2 antibodies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Age-stratified sample from general population with 3 subgroups: 1. Healthcare workers (HCWs), comprising frontline doctors, nurses, health attendants, and receptionists. 2. Healthy blood donors and healthy subjects in blood bank or laboratory (routine examinations as pre-employment, likely to be representative of the general population 3. Convalescents
Key inclusion criteria (2 listed)
- Not previously diagnosed with COVID-19 except for convalescents
- Not currently symptomatic with fever or respiratory symptoms (cough, dyspnea)
Key exclusion criteria (2 listed)
- Patients with fever or respiratory symptoms (cough, dyspnea)
- Refusal to give informed consent, or contraindication to venipuncture.
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 |
|---|---|---|
| Specific anti-SARS-CoV-2 antibodiesA serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples. All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA). | Biological | Convalescents, Healthcare workers (HCWs), Healthy blood donors and healthy subjects in blood bank |
Primary outcome
Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies
Time frame: 3 Months
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 9 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for COVID
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Corona Virus Infection, run by Egyptian Center for Research and Regenerative Medicine at 2 sites 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies (time frame: 3 Months). 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 9 Mar 2021.