Rhinocerebral Mucormycosis in COVID-19 Patients.

Active, not recruiting

Conditions: Rhinocerebral mucormycosis, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/08/035670

Lead Sponsor: Dr Ujjwala Maheshwari

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?

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Age 18 years of age and above with or without Diabetes Mellitus.
1. Participants diagnosed with covid-19 and being hospitalized and undergoing treatment for the same for the prospective group.
1. 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.

Exclusion Criteria

Participants who have succumbed to COVID-19 during the duration of study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1): MGM Medical College and Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
MGM Medical College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Ujjwala Maheshwari
Principal investigator
9920037611
maheshwarium@yahoo.com