COVID 19 Viral Clearance Among the Infected Healthcare Wo... | NCT04409574

Studies
COVID 19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals

NCT04409574

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jun 4, 2020Actual

Enrollment

31Estimated

Phase

Not provided

Conditions

Infection, Coronavirus

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2020Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	basline

Secondary Outcomes

Measure	Description	Time Frame
knowledge and practice of infection control measures	good and bad knowledge or practice	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Covid 19 infected healthcare workers.

Exclusion Criteria:

Risky healthcare workers (diabetic hypertensive and more than 50 years)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Covid 19 infected healthcare workers in Assiut University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariam elkhayat, lecturer	Contact	00201003708261	00201003708261	mariam.elkhayat@aun.edu.eg
Azza Ezzeldin, professor	Contact	01001918207		Azzam80@hotmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31995857	Background	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.
29128390

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases