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CTRI Number  CTRI/2021/07/034589 [Registered on: 05/07/2021] Trial Registered Prospectively
Last Modified On: 21/10/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Mucormycosis(fungal infection) patients with and without COVID-19  
Scientific Title of Study   A Multcenter, Case-control study on Mucormycosis in COVID-19 and Non COVID-19 patients in India (MUCOVIvi-2 Study-India) 
Trial Acronym  MUCOVI-2 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arunaloke Chakrabarti 
Designation  Professor and Head of Department 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Medical Microbiology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  arunaloke@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arunaloke Chakrabarti 
Designation  Professor and Head of Department 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Medical Microbiology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  arunaloke@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arunaloke Chakrabarti 
Designation  Professor and Head of Department 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Medical Microbiology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  arunaloke@hotmail.com  
 
Source of Monetary or Material Support  
World health Organization (India Office), Office of the WHO Representative to India 537, A Wing, Nirman Bhawan Maulana Azad Road New Delhi 110 011 
 
Primary Sponsor  
Name  World health Organization India Office 
Address  Office of the WHO Representative to India 537, A Wing, Nirman Bhawan Maulana Azad Road New Delhi 110 011, India 
Type of Sponsor  Other [World health Organization (India Office)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 27  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Immaculata Xess   All India Institute of Medical sciences, New- Delhi  Dept. of Microbiology AIIMS, Delhi
New Delhi
DELHI 
9818268181

immaxess@gmail.com 
Dr Vinay Hallur   All India Institute of Medical Sciences, Bhubaneswar  Department of Microbiology, Sijua, Patrapada, Bhubaneswar, Odisha 751019
Baleshwar
ORISSA 
9041018625

vinay118@gmail.com 
Dr Nandini S   Apollo Hospital Chennai  Department of Microbiology, 21 Greams Lane, Off, Greams Road, Thousand Lights, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU 
9855700393

drnandinipgi@gmail.com 
Dr Manoj Shevkani  Avron Hospital  Dept. of infectious Disease, Avron hospital , 4, Shantiniketan Park, Sardar Patel Colony, Ahmedabad, Gujarat 380013
Ahmadabad
GUJARAT 
9825431324

shevkanimanoj@gmail.com 
Dr Surabhi Madan  Care Institute of Medical Sciences (CIMS) Hospital  Department of Infectious Diseases, Science City Rd, Science City, Panchamrut Bunglows II, Sola, Ahmedabad, Gujarat 380060
Ahmadabad
GUJARAT 
9712971863

drsurabhimadan@gmail.com 
Dr Dharmesh Patel  City Clinic and Bhailal Amin General Hospital , Vadodara   Department of Pulmonology and Chest Medicine, Bhailal Amin Marg, Road, Gorwa, Vadodara, Gujarat 390003
Vadodara
GUJARAT 
9879519889

pateldbp@gmail.com 
Dr Laxmikant Yenge  Deenanath Mangeshkar Hospital and Research Center   Department of Pulmonary Medicine and Critical Care, Near Mhatre Bridge,Erandawne, Pune 411004
Pune
MAHARASHTRA 
2040151000

drlucky19@gmail.com 
Dr Manish Munjal   DMC, Ludhiana  Department of ENT,Dayanand Medical College, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 
9814328982

dr_manish_munjal@dmch.edu 
Dr Varsha Gupta  Government Medical College, Chandigarh  Department of Microbiology, GMCH-32, Chandi Path, Sector 32B, Chandigarh, 160047
Chandigarh
CHANDIGARH 
9646121571

varshagupta_99@yahoo.com 
Dr Raminder Sibia   Government Medical college, Patiala  Dept. of Medicine, Government Medical college, Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Punjab 147001,
Patiala
PUNJAB 
9814246633

drsibia1@yahoo.com 
Dr Ravindra Mehta  Imperial Hospital And Research Centre (Apollo) Bannerghatta  Department of Pulmonology and Critical Care, 154, 11, Bannerghatta Main Rd, opp. IIM, Krishnaraju Layout, Amalodbhavi Nagar, Panduranga Nagar, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA 
8026304050

ravihetal@gmail.com 
Dr Ragini Tilak  Institute of Medical Sciences B.H.U,Varanasi  Department of Microbiology, Aurobindo Colony, Banaras Hindu University Campus, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 
9918666501

raginijain29@rediffmail.com 
Dr Ashwini Tayade  Kingsway Hospital  Department of Infectious Diseases, SPANV Medisearch Lifesciences Pvt. Ltd., kingsway hospital 44, Kingsway Near Kasturchand Park, Nagpur, Maharashtra 440001
Nagpur
MAHARASHTRA 
8408871177

drashwini.tayade@gmail.com 
Dr Tanu Singhal   Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Department of Pediatrics, Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053
Mumbai (Suburban)
MAHARASHTRA 
9320211770

tanusinghal@yahoo.com 
Dr Deepak Thangaraju   Kovai Medical Center and Hospital  Department of Microbiology, Avinashi Rd, Peelamedu, Indira Nagar, Civil Aerodrome Post, Tamil Nadu 641014
Coimbatore
TAMIL NADU 
9814453433

drdeepaktju@gmail.com 
Dr Vasant Nagvekar  Lilavati Hospital  Department of Internal Medicine, A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050
Mumbai (Suburban)
MAHARASHTRA 
9820055178

drnagvekar@gmail.com 
Dr Sanjay Pujari  Poona Hospital & Research  Deptartment of Medicine, Centre 27, Sadashiv Peth, Nr. Alka Talkies, Pune 411030, Maharashtra
Pune
MAHARASHTRA 
9822058985

sanjaypujari@gmail.com 
Dr Arunaloke Chakrabarti  Post Graduate Institute of Medical Education and Research  Department of Medical Microbiology, Research Block A, 2nd floor, PGIMER,Chandigarh
Chandigarh
CHANDIGARH 
9914208244

arunaloke@hotmail.com 
Dr Puneet Saxena  R and R Hospital, New Delhi  Department of Medicine, Army R and R Hospital, Dhaula Kuan, Delhi · Delhi Cantt, Dhaula Kuan, Delhi - 110010
New Delhi
DELHI 
7798982797

drsaxenap@gmail.com 
Dr Arjun Srinivasan  Royal Care Hospitals  Dept. of Interventional Pulmonologists, 1/520, L & T Bye Pass Road, Coimbatore, Tamil Nadu 641062
Coimbatore
TAMIL NADU 
4222227000

drarjun81@gmail.com 
Dr Rungmei Marak  SGPGI Lucknow  Department of Microbiology, Sanjay Gandhi Postgraduate Institute of Medical SciencesNew PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH 
9839055734

rungmei@gmail.com 
Dr Prakash Shastri  Sir Gangaram Hospital, Delhi  Department of allied MEdicine, institute of Critical care, Rajinder Nagar,Sir Gangaram Hospital 110060
New Delhi
DELHI 
9810937295

prakashshastri@live.in 
Dr Sudhir Bhandari  SMS Medical College & Attached Hospitals  Department of Internal Medicine,Diabetes and Endocrinology, J.L.N. Marg, pincode: 302004
Jaipur
RAJASTHAN 
9829078844

principalsmsmc@rajasthan.gov.in 
Dr Pratik Savaj  Smt. Rasilaben Sevantilal Shah Venus Hospital  Depart ment of infectious Diseases, Ashakatashram Campus, Venus Hospital Rd, near Lal Darwaja Flyover, Surat, Gujarat 395003
Surat
GUJARAT 
9429889450

pratiksavaj2@gmail.com 
Dr Jayanthi Savio  St Johns Medical College & Hospital  Department of Microbiology, SJMC, Sarjapur Road, Bangalore - 560034, Karnataka
Bangalore
KARNATAKA 
9880250127

jayanthisjmc@gmail.com 
Dr Atul Patel  Sterling Hospital  department of Infectious Diseases, Near Agracent High School, Near Gurukul, Sterling Hospital Road, Memnagar, Ahmedabad, Gujarat-380052
Ahmadabad
GUJARAT 
9426182696

atulpatel65@gmail.com 
Dr Nagarjuna Maturu   Yashoda Hospitals, Somajiguda, Hyderabad  Department of Pulmonology, Raj Bhavan Rd, Matha Nagar, Somajiguda, Hyderabad, Telangana 500082
Hyderabad
TELANGANA 
4045674597

arjunjipmer@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 27  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, BhubaneswarIEC  Approved 
Apollo Hospital Chennai IEC  Approved 
Avron Multi Sepciality Hospital Ethics Committee  Approved 
CIMS Hospital IEC  Approved 
City Clinic and Bhailal Amin General Hospital , Vadodara  Approved 
Deenanath Mangeshkar Hospital and Research Cente  Submittted/Under Review 
DMC, Ludhiana  Submittted/Under Review 
Government Medical College, Chandigarh  Approved 
Government Medical college, Patiala  Approved 
Imperial Hospital And Research Centre (Apollo) Bannerghatta  Approved 
Institute Ethics Committee, All India Institute of Medical Sciences, Room No 102 1st Floor Old O.T. Block, Ansari Nagar, New Delhi - 110029  Approved 
Institute Ethics Committee, PGIMER  Approved 
Institute of Medical Sciences B.H.U  Approved 
Kingsway Hospital  Approved 
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Approved 
Kovai Medical Center and Hospital  Approved 
Lilavati Hospital  Submittted/Under Review 
Poona Hospital & Research  Approved 
R and R Hospital, New Delhi  Approved 
Royal Care Hospitals  Submittted/Under Review 
SGPGI Lucknow  Submittted/Under Review 
Sir Gangaram Hospital  Approved 
SMS Medical College & Attached Hospitals  Approved 
Smt. Rasilaben Sevantilal Shah Venus Hospita  Approved 
St. Johns Medical College Hospital, Institution Ethics Committee, Sarjapur Road, Bangalore  Approved 
Sterling Hospital Ethics Committee, Sterling hospital, Ahmedabad  Approved 
Yashoda Hospitals, Somajiguda, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consecutive confirmed and probable (probable only for pulmonary or disseminated disease) mucormycosis cases diagnosed during the study period will be enrolled (both COVID-19 related and unrelated). Additionally, for each COVID-19 associated mucormycosis (CAM), we will include two age- (± 5 years) and sex-matched cases of COVID-19 cases without mucormycosis as controls.
A diagnosis of mucormycosis will be made in subjects with a compatible clinical and radiological presentation and the demonstration of fungi in the tissue (or sterile body fluids) by either direct microscopy (broad ribbon-like aseptate hyphae) or isolation of Mucorales. Patients will be classified as ‘proven’ mucormycosis, defined by the presence of aseptate hyphae in the biopsied sample from deep tissue or isolation of Mucorales from sterile sites. “Probable” pulmonary or disseminated mucormycosis will be defined based on the host risk factors (both classical and putative), radiological findings, and demonstration of the fungi by either culture or cytology from any site. A diagnosis of COVID-19 will be made in subjects positive for SARS-CoV-2 RNA in respiratory specimens by reverse transcription-polymerase chain reaction (RT-PCR) or a positive rapid antigen test. CAM will be defined as the occurrence of proven or probable mucormycosis (up to 3 months) in COVID-19 subjects.
 
 
ExclusionCriteria 
Details  Patients with endemic mycoses (histoplasmosis, sporotrichosis,
penicilliosis), yeast infections, and allergic fungal diseases like
allergic bronchopulmonary aspergillosis will not be included. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India.
• To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population.
• To study the treatment practices and the outcomes of the patients with mucormycosis.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the types of mucormycosis (site of infection) in those infected with the disease
To assess the prevalence of mucormycosis among the COVID-19 cases in the second wave of the pandemic in India.
To evaluate the predictors of mortality in COVID-19 associated mucormycosis (CAM).
 
6 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   21/07/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   There are no results yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arunaloke@hotmail.com].

  6. For how long will this data be available start date provided 01-08-2021 and end date provided 31-12-2021?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The COVID-19 pandemic has been associated with a rise in the serious fungal infection, ‘mucormycosis’.While our earlier study identified some risk factors for COVID-19 associated mucormycosis (CAM), more data is required to identify additional causes. We, therefore, propose to conduct this retrospective multicentre study to evaluate the possible causes associated with an increase in mucormycosis cases due to Covid-19, risk factors, treatment and outcome of these cases. A retrospective case-control study will be conducted across 27 centres in India from 1st January to 31st July. All consecutive mucormycosis cases will be enrolled (both COVID-19 related and unrelated. The standard case-record form will be used for data collection followed by analysis. Any patient factors contributing to the risk of mucormycosis in COVID-19 will be identified. The issues related to treatment and predictors of the outcome can be delineated which will help in guiding patient management.

 

 
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