COVID-19 Associated Mucormycosis: A Multidisciplinary Dil... | NCT05074043

Studies
COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital

NCT05074043

Sponsor

Assiut University

Status

Completed

Last Update Posted

Oct 12, 2021Actual

Enrollment

433Actual

Phase

Not provided

Conditions

Mucormycosis

Interventions

antiviral, surgical

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

Oct 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

Mar 1, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 12, 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

Oct 5, 2021

Last Update Posted Date

Oct 12, 2021Actual

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

We aimed to describe the frequency; presentations, predictors, in-hospital outcome of mucormycosis patients in the scope of COVID-19.

All patients with COVID-19 associated Mucormycosis (CAM) admitted to Assuit University Hospital between March 1, 2021, and July 30, 2021, were included in this study. The patient characteristics, the site of mucormycosis, the comorbidities, the steroids usage, and the outcome were analyzed in people with 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

433Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
covid19		covid 19 proven by clinical, PCR. not associated with mucor
covid19 associated with mucor		covid19 associated with mucor proven by clinical, histopathological	Combination Product: antiviral, surgical

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antiviral, surgical	Combination Product	surgical debridment	covid19 associated with mucor

Measure	Description	Time Frame
incidence of covid19 associated mucor		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:We recruited all cases admitted to Assuit University Hospital for the management of COVID-19 and/or associated complications between March 1, 2021, and July 30, 2021, specifically those with probable mucormycosis based on clinical condition. At various times, internists, intensivists, neurologists, and otolaryngologists were among the specialists who assessed and treated them. Clinical; radiological and histopathological confirmed cases of mucormycosis with coexisting or previous history of COVID-19 were included in this study.

Exclusion Criteria:Participants with fungal infections other than mucormycosis or without a confirmed diagnosis of COVID-19 (or serological evidence of preceding COVID-19) were excluded.

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

Participants with mucormycosis in a confirmed diagnosis of COVID-19

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Marwa Abdelrady		Asyut		11711	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009091	Mucormycosis

Ancestor Terms

ID	Term
D020096	Zygomycosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000998	Antiviral Agents
D013514	Surgical Procedures, Operative

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided