Back to the Traditional: Anti-COX Drugs Can Improve the O... | NCT04757792

Studies
Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU

NCT04757792

Sponsor

Benha University

Status

Completed

Last Update Posted

Feb 17, 2021Actual

Enrollment

475Actual

Phase

Not provided

Conditions

COVID-19 Disease

Interventions

File inquiry

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2020Actual

Primary Completion Date

Feb 1, 2021Actual

Completion Date

Feb 11, 2021Actual

First Submitted Date

Feb 11, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 17, 2021Actual

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

Feb 16, 2021

Last Update Posted Date

Feb 17, 2021Actual

Name	Class
Tanta University	OTHER
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.

Detailed Description

The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes

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

475Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
No NSAID	included patients who did not receive NSAID prior to having COVID-19 disease	Other: File inquiry
Apsirin	included patients who received acetylsalicylic acid (ASA) prior to having COVID-19 disease	Other: File inquiry
Celecoxib	included patients who received celecoxib (CEL) prior to having COVID-19 disease	Other: File inquiry
Miscellaneous	included patients who received miscellaneous NSAID other than ASA or CEL prior to having COVID-19 disease	Other: File inquiry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
File inquiry	Other	Data extraction out of file registry	Apsirin Celecoxib Miscellaneous No NSAID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality rate	number of patients who were died secondary to COVID-19 disease or its complications	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with diagnosis of COVID-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adel Alkholy, Prof	Faculty of medicine, Banha University, Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Banhā	Qalyubia Governorate	0013	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Protocol data will be available on request

Types

Study Protocol

Time Frame

After publishing

Access Criteria

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