NCT04757792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 11, 2021

Last Update Submit

February 16, 2021

Conditions

COVID-19 Disease

Keywords

COVID-19NSAIDAspirinMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    number of patients who were died secondary to COVID-19 disease or its complications

    6 months

Study Arms (4)

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

File inquiryOTHER

Data extraction out of file registry

Also known as: No interventions
ApsirinCelecoxibMiscellaneousNo NSAID

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with diagnosis of COVID-19

You may qualify if:

  • assured diagnosis of COVID-19 by RT-PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Banhā, Qalyubia Governorate, 0013, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Adel Alkholy, Prof

    Faculty of medicine, Banha University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Biochemistry

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

June 6, 2020

Primary Completion

February 1, 2021

Study Completion

February 11, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Protocol data will be available on request

Shared Documents
STUDY PROTOCOL
Time Frame
After publishing
Access Criteria
email

Locations

EG(1)