Clinical trial NCT05097664: Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran
Official title: Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Mucormycosis
Keywords: Coronavirus Disease-Associated Mucormycosis
COVID-19
Rhino-orbital-cerebral mucormycosis
Mucormycosis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
name: Ahvaz Jundishapur University of Medical Sciences
name: Iran University of Medical Sciences
name: Mashhad University of Medical Sciences
name: Tabriz University of Medical Sciences
name: Guilan University of Medical Sciences
name: Kermanshah University of Medical Sciences
name: Shahid Beheshti University of Medical Sciences
name: Semnan University of Medical Sciences
First posted: 2021-10-28
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Coronavirus Disease-Associated Mucormycosis

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Vision loss
timeFrame: 3 months
Secondary outcomes:
measure: Risk factors
timeFrame: 3 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan Eye Research Center
name: Mohsen Pourazizi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: