NCT04935463

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

June 21, 2021

Last Update Submit

April 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vision loss

    60 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Diagnosed case of Mycotic Infection in COVID-19

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

COVID-19MucormycosisAspergillosisCandidiasis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesZygomycosisMycosesBacterial Infections and Mycoses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 23, 2021

Study Start

May 24, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations