COVID-19NCT05097664
Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran
An observational study of COVID-19 and Mucormycosis, run by Isfahan University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Mucormycosis
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- 23 Aug 2021to 20 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Coronavirus Disease-Associated Mucormycosis
Who may be able to join
- Diagnosed case of Mucormycosis in COVID-19 pandemic
Who cannot join
- People with acute or severely ill conditions that prevent them from ophthalmic examination.
- Patient, or legal representative opposing the pursuit of the research
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan, +98
Mohsen Pourazizi, +98, m.pourazizi@yahoo.com
About this study
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.
Read the detailed description
Investigators will achieved the following data from the participants:
- Demographic
- Past medical/habitual history
- COVID-19 status and related risk factors
- Mucormycosis status and related risk factors
- Ocular examination and imaging
- Follow-up
- Conditions
- COVID-19, Mucormycosis
- Keywords
- Coronavirus Disease-Associated Mucormycosis, COVID-19, Rhino-orbital-cerebral mucormycosis, Mucormycosis
- Medical subject headings
- COVID-19, Mucormycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision loss
Prevalence of Vision loss in COVID-19 patients with Mucormycosis co-infection
Measured: 3 months
Secondary outcomes (1)
Risk factors
Related risk factors for vision loss
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start23 Aug 2021
- Primary completion21 Nov 2021 (estimated)
- Study completion20 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Iran University of Medical Sciences, Mashhad University of Medical Sciences, Tabriz University of Medical Sciences, Guilan University of Medical Sciences, Kermanshah University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Semnan University of Medical Sciences
- Responsible party
- Principal investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
- Investigators
- Mohsen Pourazizi, M.D., Principal investigator, Isfahan Eye Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097664
- Sponsor's protocol ID
- IR.MUI.MED.REC.1400.572
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eshraghi B, Khademi B, Bahmani Kashkouli M, Khataminia G, Kiarudi MY, Nabie R, Abounoori M, Chaibakhsh S, Ghahvehchian H, Rastegarnasab F, Parandin M, Zia Z, Karamirad S, Jafarpour S, Fakoor M, Varshochi M, Mirmohammadkhani M, Ramezani-Majd A, Janipour M, Mahdian Rad A, Shekarchian F, Manouchehri V, Sajjadi SMJ, Etezad Razavi M, Khosropour H, Forouhari A, Ebrahimi F, Pourazizi M. One-Year Patient Survival After COVID-19-Associated Rhino-Orbital-Cerebral Mucormycosis: A Multicenter Study. Mycopathologia. 2025 Jul 6;190(4):63. doi: 10.1007/s11046-025-00966-2.
PubMed 40619554
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran
- ClinicalTrials.gov ID
- NCT05097664
- Acronym / sponsor ID
- IR.MUI.MED.REC.1400.572
- Conditions
- COVID-19, Mucormycosis
- Keywords
- Coronavirus Disease-Associated Mucormycosis, COVID-19, Rhino-orbital-cerebral mucormycosis, Mucormycosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Iran University of Medical Sciences, Mashhad University of Medical Sciences, Tabriz University of Medical Sciences, Guilan University of Medical Sciences, Kermanshah University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Semnan University of Medical Sciences
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 21 Nov 2021 (estimated)
- Study completion
- 20 Jan 2022 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Demographic
- Past medical/habitual history
- COVID-19 status and related risk factors
- Mucormycosis status and related risk factors
- Ocular examination and imaging
- Follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Coronavirus Disease-Associated Mucormycosis
Key inclusion criteria (1 listed)
- Diagnosed case of Mucormycosis in COVID-19 pandemic
Key exclusion criteria (2 listed)
- People with acute or severely ill conditions that prevent them from ophthalmic examination.
- Patient, or legal representative opposing the pursuit of the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vision loss
Time frame: 3 months
Prevalence of Vision loss in COVID-19 patients with Mucormycosis co-infection
1 secondary outcome
Risk factors
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 40619554Eshraghi B, Khademi B, Bahmani Kashkouli M, Khataminia G, Kiarudi MY, Nabie R, Abounoori M, Chaibakhsh S, Ghahvehchian H, Rastegarnasab F, Parandin M, Zia Z, Karamirad S, Jafarpour S, Fakoor M, Varshochi M, Mirmohammadkhani M, Ramezani-Majd A, Janipour M, Mahdian Rad A, Shekarchian F, Manouchehri V, Sajjadi SMJ, Etezad Razavi M, Khosropour H, Forouhari A, Ebrahimi F, Pourazizi M. One-Year Patient Survival After COVID-19-Associated Rhino-Orbital-Cerebral Mucormycosis: A Multicenter Study. Mycopathologia. 2025 Jul 6;190(4):63. doi: 10.1007/s11046-025-00966-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Pourazizi, M.D. principal investigator
Isfahan Eye Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Mucormycosis, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Pourazizi, M.D. (00983134452036, m.pourazizi@med.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.