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CTRI Number  CTRI/2021/08/035670 [Registered on: 16/08/2021] Trial Registered Prospectively
Last Modified On: 27/06/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Rhinocerebral Mucormycosis in COVID-19 Patients. 
Scientific Title of Study   Incidence and Screening for Rhinocerebral Mucormycosis and its risk factors in patients with COVID-19: A Multicentric Combined Retrospective and Prospective Cohort Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ujjwala Maheshwari 
Designation  Professor 
Affiliation  MGM Medical College and Hospital Navi Mumbai 
Address  Department of Pathology, Ground Floor, MGM Medical College and Hospital, Kamothe, Sector 1, Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9920037611  
Fax    
Email  maheshwarium@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srivalli Natarajan 
Designation  Professor and Head of the Department 
Affiliation  MGM Dental College and Hospital Navi Mumbai 
Address  Department of Oral and Maxillofacial Surgery, Fourth Floor, MGM Medical College and Hospital, Kamothe, Sector 1, Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9769088803  
Fax    
Email  srivalli.shrikanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usha Asnani 
Designation  Professor 
Affiliation  MGM Dental College and Hospital Navi Mumbai  
Address  Department of Oral and Maxillofacial Surgery, Fourth Floor, MGM Medical College and Hospital, Kamothe, Sector 1, Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9820897181  
Fax    
Email  drushaasnani@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Missions medical college and Hospital, Sector 1, Kamothe, Navi Mumbai  
 
Primary Sponsor  
Name  Dr Ujjwala Maheshwari 
Address  Department of General Pathology, Central Laboratory division, MGM Medical College and Hospital, Sector 1, Kamothe, Navi Mumbai Maharashtra 410209 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ujjwala Maheshwari  MGM Medical College and Hospital  Room No. 27, Ground Floor, Central Laboratory Division, Department of general pathology, Mahatma Gandhi Missions hospital Sector 1 Kamothe navi mumbai
Raigarh
MAHARASHTRA 
9920037611

maheshwarium@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B461||Rhinocerebral mucormycosis, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Age 18 years of age and above with or without Diabetes Mellitus.
2) Participants diagnosed with covid-19 and being hospitalized and undergoing treatment for the same for the prospective group.
3) Participants who have been deemed clinically recovered from COVID 19 and discharged up to 28 days prior to the commencement of participant recruitment for the retrospective group
 
 
ExclusionCriteria 
Details  Participants who have succumbed to COVID-19 during the duration of study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To screen for Rhino Cerebral Mucormycosis and study the incidence of the same in patients with COVID 19.
 
To screen for Rhino Cerebral Mucormycosis and study the incidence of the same in patients with COVID 19 at 2 weeks, 4 weeks and 6 weeks after discharge.
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of Rhino Cerebral Mucormycosis in moderate to severe covid cases hospitalized for the management of COVID 19.   at 2 weeks, 4 weeks and 6 weeks after discharge. 
To detect Rhino Cerebral Mucormycosis prior to the clinical onset of the disease in these cases using cytological, histopathological and microbiological methods.
 
at 2 weeks, 4 weeks and 6 weeks after discharge. 
To study the correlation of Pharmacotherapy with Steroids, Immunomodulator drugs, Oxygen Supplementation and Antibiotics for COVID-19 with the relative risk of development of Rhino Cerebral Mucormycosis in these patients.
 
at 2 weeks, 4 weeks and 6 weeks after discharge. 
To study Post covid cases for development of ROCM within 4 weeks of discharge from the hospital   at 2 weeks, 4 weeks and 6 weeks after discharge. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

COVID-19, labelled as a disease which primarily affects the lungs, is now accepted to have significant  effects on the helper T cell responses and cytokine release which contribute to immune dysregulation and  hence increased susceptibility to coinfections. Literature demonstrates the association of bacterial and  fungal infections in patients suffering from COVID 19.[1-3] The protracted course of this viral disease has  now led to supervened infections of fungal origin. The prevalence of co-infections, fungal in particular and  Rhino-Orbito-Cerebral Mucormycosis (ROCM) to be specific has been on the rise and this has been  attributed to the disease induced lowered immunity, further compounded by comorbid conditions like  uncontrolled Diabetes Mellitus, use of Broad spectrum antibiotics, corticosteroids and supportive invasive  and non invasive ventilation methods for management of COVID-19.[4] Local Thromboembolism due to  COVID-19, and angio invasive ROCM, both complementing each other compromise blood supply in the  maxillofacial region and create an avascular milieu which encourage bacteria and fungi to colonise, thrive  and flourish. Hence the disease process of COVID- 19 and treatment modalities that follow seem to have  an overbearing influence on the development of fungal and bacterial co-infections whose presentation is  found to be more aggressive with rapid spread breaching barriers and culminating in high mortality rates.  [5] 

Hence the post Covid aftermath of ROCM may have to be considered as a clinically different disease  scenario than the ones reported in literature during the Pre-COVID-19 times. Early diagnosis by  Scrupulous surveillance during and after recovery from COVID 19 would be the key for successful  treatment outcomes. The rationale of this study is to determine the incidence and correlations if any  between COVID 19 and other risk factors like DM.use of steroids and development of co-infections with  ROCM. This study will also help to throw light on the simple screening tool for surveillance and early  diagnosis of ROCM in COVID-19 patients.

3.1) Research Question 1 

Is there higher susceptibility of Rhinocerebral Mucormycosis in patients with COVID-19 getting  hospitalized for management of COVID-19? 

3.2) Research Question 2 

Can Rhinocerebral Mucormycosis be detected using cytological, histopathological and microbiological  methods prior to the clinical onset of the disease in patients suffering from COVID 19?  


 
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