Corona-Like Illness: Did we Got it Before WHO Announcemen... | NCT04336657

Studies
Corona-Like Illness: Did we Got it Before WHO Announcement of the Disease?

NCT04336657

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 7, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Questionnaire
IgG

Countries

Egypt

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

May 2020Estimated

Completion Date

May 2020Estimated

First Submitted Date

Apr 3, 2020

First Submission Date that Met QC Criteria

Apr 3, 2020

First Posted Date

Apr 7, 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

Apr 3, 2020

Last Update Posted Date

Apr 7, 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

A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Our team as well as many reports suggested that in some countries a " Flu like illness but much worse" was described in October, November and early in December before the WHO announcement. Was it COVID-19?

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Survey to identify number of people who got unusual severe flu- like illness in last October- November
IgG	Diagnostic Test	Measure the past immunity of the disease (if possible)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure frequency of people suffered from unusual flu-like symptoms before December 2019	fever, dry cough, dyspnea, malaise, headache	one month

Secondary Outcomes

Measure	Description	Time Frame
Measure remote immunity for COVID-19 in subject with past history of severe flu before WHO announcement date- if possible	serum IgG	3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subject except excluded group

Exclusion Criteria:

subject diagnosed as COVID-19 positive and their contacts

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The survey will be distributed online in English and Arabic and all responders well be included

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aliae Mohamed-Hussein	Contact	01222302352		aliaehussein@aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AssiutU	Recruiting	Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided