Infection, CoronavirusNCT04409574
COVID 19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals
An observational study of Infection, Coronavirus, run by Assiut University.
Trial summary
This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Infection, Coronavirus
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Covid 19 infected healthcare workers in Assiut University Hospital
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: COVID19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals
This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms
Read the detailed description
COVID-19 has been spreading rapidly globally, with a considerable impact on global morbidity, mortality and healthcare utilization. This viral disease is caused by the Coronaviruses (CoV) which belong to the genus'coronavirus' of the Coronaviridae family.
Coronaviruses are enveloped positive strand RNA viruses with the largest known RNA genomes-30-32 kb-with a 50 -cap structure and 30 -poly-A tail (Lei et al.2018). The transcription works through the replication-transcription complex (RCT) organized in double-membrane vesicles and via the synthesis of subgenomic RNAs (sgRNAs) sequences. Of note, transcription termination occurs at transcription regulatory sequences, located between the so-called open reading frames (ORFs). In the atypical CoV genome, at least six ORF scan could be present (Woo et al., 2020) .
Health workers are at the front line of the COVID-19 outbreak response and as such are exposed to hazards that put them at risk of infection (Li e al.,2020). thus keeping the implementation of infection prevention and control (IPC) and its knowledge and practice are of great importance in healthcare settings to protect them from infections (Wang et al., 2020).
- Conditions
- Infection, Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms.
different relations between different symptoms, investigation results and time of viral clearness
Measured: basline
Secondary outcomes (1)
knowledge and practice of infection control measures
good and bad knowledge or practice
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 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 Infection, CoronavirusStudies 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
- Cross-sectional
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409574
- Sponsor's protocol ID
- COVID19 among HCWs
- Status last verified
- Jun 2020
- First submitted
- 28 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.
PubMed 29128390Wang J, Zhou M, Liu F. Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect. 2020 May;105(1):100-101. doi: 10.1016/j.jhin.2020.03.002. Epub 2020 Mar 6. No abstract available.
PubMed 32147406Woo PCY, Huang Y, Lau SKP, Yuen KY. Coronavirus genomics and bioinformatics analysis. Viruses. 2010 Aug;2(8):1804-1820. doi: 10.3390/v2081803. Epub 2010 Aug 24.
PubMed 21994708
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04409574
- Acronym / sponsor ID
- COVID19 among HCWs
- Conditions
- Infection, Coronavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 1 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.
This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms
Detailed description
COVID-19 has been spreading rapidly globally, with a considerable impact on global morbidity, mortality and healthcare utilization. This viral disease is caused by the Coronaviruses (CoV) which belong to the genus'coronavirus' of the Coronaviridae family.
Coronaviruses are enveloped positive strand RNA viruses with the largest known RNA genomes-30-32 kb-with a 50 -cap structure and 30 -poly-A tail (Lei et al.2018). The transcription works through the replication-transcription complex (RCT) organized in double-membrane vesicles and via the synthesis of subgenomic RNAs (sgRNAs) sequences. Of note, transcription termination occurs at transcription regulatory sequences, located between the so-called open reading frames (ORFs). In the atypical CoV genome, at least six ORF scan could be present (Woo et al., 2020) .
Health workers are at the front line of the COVID-19 outbreak response and as such are exposed to hazards that put them at risk of infection (Li e al.,2020). thus keeping the implementation of infection prevention and control (IPC) and its knowledge and practice are of great importance in healthcare settings to protect them from infections (Wang et al., 2020).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Covid 19 infected healthcare workers in Assiut University Hospital
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.
Primary outcome
the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms.
Time frame: basline
different relations between different symptoms, investigation results and time of viral clearness
1 secondary outcome
knowledge and practice of infection control measures
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- Background: PubMed 29128390Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.
- Background: PubMed 32147406Wang J, Zhou M, Liu F. Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect. 2020 May;105(1):100-101. doi: 10.1016/j.jhin.2020.03.002. Epub 2020 Mar 6. No abstract available.
- Background: PubMed 21994708Woo PCY, Huang Y, Lau SKP, Yuen KY. Coronavirus genomics and bioinformatics analysis. Viruses. 2010 Aug;2(8):1804-1820. doi: 10.3390/v2081803. Epub 2010 Aug 24.
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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 Infection, Coronavirus, 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 4 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 Mariam elkhayat, lecturer (00201003708261 ext. 00201003708261, mariam.elkhayat@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms. (time frame: basline). 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 NCT04409574, 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 4 Jun 2020.