Mucormycosis; Rhinocerebral (Etiology)Phase 1/2NCT06267326
World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
A Phase 1/2 study testing debridment in people with Mucormycosis; Rhinocerebral (Etiology) and COVID-19, run by Nasser Institute For Research and Treatment at 1 site in Egypt.
Trial summary
Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection Read more about this study
- Who is it for?
- Ages 22 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucormycosis; Rhinocerebral (Etiology), COVID-19
- What is being tested?
- debridment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2021to 21 Aug 2023
- Phase
- Phase 1/2
- 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 22 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients with mucormycosis post covid 19
Who cannot join
- The patient not suffered from covid 19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection
- Conditions
- Mucormycosis; Rhinocerebral (Etiology), COVID-19
- Being tested
- debridment
- Medical subject headings
- Mucormycosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridmentProcedure or surgery
Also called medication
resection of dead bone
| Study group | Role | What they receive |
|---|---|---|
| Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years | Other | Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors Receives: Procedure: debridment |
| Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 | Experimental | Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors Receives: Procedure: debridment |
What is being measured
The primary outcome is the main question the study is designed to answer.
35 patients suffering from mucormycosis infection post covid 19
Ratio Scale. Visual Analog Score for pain Ratio Scale. Ratio Scale. ratio scale
Measured: 2 years
25 patients were cured with comorbidity and 10 pateints died
ordinal scale Visual Analog Score for pain
Measured: 2 years
pain
Visual Analog Score for pain
Measured: two years
Secondary outcomes (1)
Visual Analog Score for pain
pain
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 May 2021
- Primary completion12 Jun 2022
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucormycosis; Rhinocerebral (Etiology)Studies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Institute For Research and Treatment
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267326
- Sponsor's protocol ID
- Nasser institute
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
- ClinicalTrials.gov ID
- NCT06267326
- Acronym / sponsor ID
- Nasser institute
- Conditions
- Mucormycosis; Rhinocerebral (Etiology), COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nasser Institute For Research and TreatmentOther government
- Study start
- 23 May 2021 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 20 Feb 2024 (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.
Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years | Other | Procedure: debridmentTwenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors |
| Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 | Experimental | Procedure: debridmentTwenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors |
Who may qualify
- Ages
- 22 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with mucormycosis post covid 19
Key exclusion criteria (1 listed)
- The patient not suffered from 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 |
|---|---|---|
| debridmentAlso: medicationresection of dead bone | Procedure or surgery | Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17, Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years |
Primary outcome
35 patients suffering from mucormycosis infection post covid 19
Time frame: 2 years
Ratio Scale. Visual Analog Score for pain Ratio Scale. Ratio Scale. ratio scale
25 patients were cured with comorbidity and 10 pateints died
Time frame: 2 years
ordinal scale Visual Analog Score for pain
pain
Time frame: two years
Visual Analog Score for pain
1 secondary outcome
Visual Analog Score for pain
Time frame: 2years
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 20 Feb 2024.
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?
A Phase 1/2 study testing debridment in people with Mucormycosis; Rhinocerebral (Etiology) and COVID-19, run by Nasser Institute For Research and Treatment at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 20 Feb 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
35 patients suffering from mucormycosis infection post covid 19 (time frame: 2 years). The study lists 3 primary outcomes in all. 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 20 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.