MucormycosisNCT05074043
COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital
An observational study of Mucormycosis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mucormycosis
- What is being tested?
- antiviral, surgical
- How many people
- 433 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Jul 2021
- 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: Participants with mucormycosis in a confirmed diagnosis of COVID-19
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.
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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.
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Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mucormycosis
- Being tested
- antiviral, surgical
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral, surgicalCombination product
surgical debridment
| Study group | Role | What they receive |
|---|---|---|
| covid19 | covid 19 proven by clinical, PCR. not associated with mucor | |
| covid19 associated with mucor | covid19 associated with mucor proven by clinical, histopathological Receives: Combination Product: antiviral, surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of covid19 associated mucor
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 posted12 Oct 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa mahmoud Abd El Rady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074043
- Sponsor's protocol ID
- COVID-19 with mucormycosis
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05074043
- Acronym / sponsor ID
- COVID-19 with mucormycosis
- Conditions
- Mucormycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 12 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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covid19 | – | –covid 19 proven by clinical, PCR. not associated with mucor |
| covid19 associated with mucor | – | Combination Product: antiviral, surgicalcovid19 associated with mucor proven by clinical, histopathological |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with mucormycosis in a confirmed diagnosis of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiviral, surgicalsurgical debridment | Combination product | covid19 associated with mucor |
Primary outcome
incidence of covid19 associated mucor
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mucormycosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of covid19 associated mucor (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2021.