Covid19MUNCONCT04935463
Mucormycosis in COVID-19
An observational study of Covid19 and Mucormycosis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Mucormycosis, Aspergillosis
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 1 Mar 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: The investigators have a web-based platform to allow physicians or other healthcare providers to report cases of confirmed Mucormycosis in patients with COVID 19. Physician reporters will individually enter de-identified data into a secure, electronic database (REDCap). The case report form will include items requesting the following information: age, country of residence, state of residence(within India), name of center/practice/physician reporting the case, gender, height, weight, patient's history specifics (diabetes, cancer, organ transplant, neutropenia, prior steroid use and intravenous drug use), COVID severity ( mild/moderate/severe), admission CRP values in mg/dL, COVID treatments prescribed, Mucormycosis treatment prescribed and site of mucormycosis( rhinocerebral, pulmonary, cutaneous or gastrointestinal) Once a reporter completes a survey, the reporter will not be able to access the survey again or update it
Who may be able to join
- Diagnosed case of Mycotic Infection in COVID-19
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. There is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (COVID-19). In light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication
- Conditions
- Covid19, Mucormycosis, Aspergillosis, Candida Infection
- Medical subject headings
- COVID-19, Mucormycosis, Aspergillosis, Candidiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision loss
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start24 May 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medanta Institute Delhi, AIIMS Patna, HCG Oncology Bangalore, NSCB Jabalpur
- Responsible party
- Principal investigator, Shitij Arora, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935463
- Sponsor's protocol ID
- 2021-13086
- Acronym
- MUNCO
- Status last verified
- Apr 2023
- First submitted
- 21 Jun 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucormycosis in COVID-19
- ClinicalTrials.gov ID
- NCT04935463
- Acronym / sponsor ID
- MUNCO / 2021-13086
- Conditions
- Covid19, Mucormycosis, Aspergillosis, Candida Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Medanta Institute Delhi, AIIMS Patna, HCG Oncology Bangalore, NSCB Jabalpur
- Study start
- 24 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 23 Jun 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.
The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. There is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (COVID-19). In light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators have a web-based platform to allow physicians or other healthcare providers to report cases of confirmed Mucormycosis in patients with COVID 19. Physician reporters will individually enter de-identified data into a secure, electronic database (REDCap). The case report form will include items requesting the following information: age, country of residence, state of residence(within India), name of center/practice/physician reporting the case, gender, height, weight, patient's history specifics (diabetes, cancer, organ transplant, neutropenia, prior steroid use and intravenous drug use), COVID severity ( mild/moderate/severe), admission CRP values in mg/dL, COVID treatments prescribed, Mucormycosis treatment prescribed and site of mucormycosis( rhinocerebral, pulmonary, cutaneous or gastrointestinal) Once a reporter completes a survey, the reporter will not be able to access the survey again or update it
Key inclusion criteria (1 listed)
- Diagnosed case of Mycotic Infection in COVID-19
Key exclusion criteria (1 listed)
- None
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: 60 days
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 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Covid19 and Mucormycosis, run by Montefiore Medical Center at 1 site in United States.
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 18 Apr 2023. 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 United States. 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?
Vision loss (time frame: 60 days). 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 18 Apr 2023.