Fugal Infection in COVID-19 Patients

• Conditions: Covid19

• Registration Number: NCT04914013
• Lead Sponsor: Assiut University

Brief Summary

Screening early detection of invasive fungal sinusitis in COVID-19 positive patients

Detailed Description

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); the causative organism of Coronavirus disease 2019 (Covid-19); infects primarily the lungs leading to more than 100 million COVID-19 cases around the world, resulting in almost three million deaths. Covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. Covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections.

Acute invasive fungal sinusitis (AIFS) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. Mucormycosis a life threatening AIFS characterized by hyphal invasion and massive destruction of maxillofacial structures. Histological characters include mycotic infiltration of vessels with propensity to tissue infarction. In addition to other fungi such as Acinetobacter, Klebsiella, Enterobacter, Aspergillus and Candida that frequently lead to secondary fungal infection in Covid-19 patients.

The co-existence of Covid-19 and AIFS is due to immune dysregulation in Covid-19 patients as both CD4+ and CD8+ T lymphocytes are suppressed thus impair patients' innate immunity. In addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. Covid-19 patients with pre-existing conditions such as untreated HIV, organ transplantation, un controlled diabetes and malignancies are more susceptible to AIFS on the contrary Covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of AIFS.

Taking in consideration raised incidence of morbidity and mortality associated with AIFS and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of AIFS in Covid-19 patients. This study aims to To assess the occurrence of AIFS superinfections in patients with Covid-19.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2021-08
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2.

Exclusion Criteria

• • Patients who received antifungal therapy within three days prior to sample collection.
• Patients refused to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection of invasive fungal sinusitis after covid 19 infection.	baseline	diagnosis of invasive fungal post COVID-19 infection

Secondary Outcome Measures

Name	Time	Method
Identify specific fungi that participate in IFS	1 month	specify by culture and sensitivity fungi that participate in invasive fungal sinusitis after covid 19 infection