Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran

October 26, 2021 updated by: Mohsen Pourazizi, Isfahan University of Medical Sciences

Coronavirus disease 2019 (COVID-19) infection caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may manifest as a variety of disease patterns, ranging from mild to life-threatening pneumonia.

Mucormycosis has been suspected to cause significant morbidity in infected people since the outbreak of the COVID-19 pandemic. Individuals who require hospitalization and intensive care are more vulnerable, as they have reached an advanced stage of their disease. Investigators will discuss the major risk factors, ocular presentation, and outcome of mucormycosis in individuals infected with SARS-CoV-2 in this study. From August 2021 to January 2022, a cross-sectional descriptive multicenter investigation would be conducted on patients with biopsy-confirmed mucormycosis and RTPCR confirmed COVID19. Demographic data, the time interval between COVID19 and mucormycosis, underlying systemic disorders, clinical characteristics, disease course, and outcomes would be analyzed.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Investigators will achieved the following data from the participants:

  1. Demographic
  2. Past medical/habitual history
  3. COVID-19 status and related risk factors
  4. Mucormycosis status and related risk factors
  5. Ocular examination and imaging
  6. Follow-up

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Coronavirus Disease-Associated Mucormycosis

Description

Inclusion Criteria:

  • Diagnosed case of Mucormycosis in COVID-19 pandemic

Exclusion Criteria:

  • People with acute or severely ill conditions that prevent them from ophthalmic examination.
  • Patient, or legal representative opposing the pursuit of the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vision loss
Time Frame: 3 months
Prevalence of Vision loss in COVID-19 patients with Mucormycosis co-infection
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors
Time Frame: 3 months
Related risk factors for vision loss
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences
Shiraz University of Medical Sciences
Ahvaz Jundishapur University of Medical Sciences
Guilan University of Medical Sciences
Mashhad University of Medical Sciences
Tabriz University of Medical Sciences
Iran University of Medical Sciences
Kermanshah University of Medical Sciences
Semnan University of Medical Sciences

Investigators

  • Principal Investigator: Mohsen Pourazizi, M.D., Isfahan Eye Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Anticipated)

November 21, 2021

Study Completion (Anticipated)

January 20, 2022

Study Registration Dates

First Submitted

October 23, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.MUI.MED.REC.1400.572

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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