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NCT05097664 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05097664
Other study ID # IR.MUI.MED.REC.1400.572
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2021
Est. completion date January 20, 2022

Study information
Verified date October 2021
Source Isfahan University of Medical Sciences
Contact Mohsen Pourazizi, M.D.
Phone 00983134452036
Email m.pourazizi@med.mui.ac.ir
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date January 20, 2022
Est. primary completion date November 21, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (10)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Guilan University of Medical Sciences, Iran University of Medical Sciences, Kermanshah University of Medical Sciences, Mashhad University of Medical Sciences, Semnan University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Shiraz University of Medical Sciences, Tabriz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vision loss Prevalence of Vision loss in COVID-19 patients with Mucormycosis co-infection 3 months
Secondary Risk factors Related risk factors for vision loss 3 months
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