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
|
|
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
|
|
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
|
|
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?
|