Post-COVID-19 Mucormycosis in Critical Care

Post COVID-19 Acute Mucormycosis in Critical Care Settings in Egypt: A Single-Center Experience

Background: Mucormycosis is a life-threatening opportunistic fungal infection. Despite mucormycosis having existed for decades, it has gained notice of its widespread in many parts of the world during the second wave of the coronavirus disease 2019 (COVID-19) pandemic. The study aimed to determine the in-hospital outcomes of post-COVID-19 mucormycosis during the intensive care unit (ICU) stay in Egypt.

Methods: This prospective cohort study included all patients admitted to the Medical ICU of the University Hospital who developed Mucormycosis with a history of previous COVID-19 infection. Clearance of previous COVID-19 was confirmed using PCR and high-resolution computed tomography (CT) on the chest before admission.

Study Overview

• Status: Completed
• Conditions: Post COVID-19 Condition, Unspecified; Mucormycosis; Rhinocerebral (Etiology)

Detailed Description

Study design, settings, and participants This prospective cohort study was conducted in the medical ICU of the Zagazig University Hospital, Egypt, comprising 150 Post COVID-19 patients who developed Mucormycosis infection.

The investigators take the approval of the Institutional Review Board (IRB) ethical committee under code (ZU-IRB#9491/26-4-2022). The study was conducted under the guidance of the Declaration of Helsinki. Written informed consent was taken from all patients or first-degree relatives in case of altered sensorium.

The inclusion criteria were all patients aged 18 or older, of both genders, and confirmed previous COVID-19 with Mucormycosis infection were included in this study. We excluded patients with other fungal infections post-COVID-19 or Mucormycosis infection without previous COVID-19.

Process For all cases, the first step was to perform a polymerase chain reaction (PCR) to exclude current COVID-19 on admission and high-resolution computed tomography (CT) on the chest.

The complete medical history was also recorded of all patients, including demographic details (age, gender, residence, and smoking) and the risk factors, such as diabetes mellitus (DM), hypertension, chronic kidney disease (CKD), and other comorbidities).

Routine laboratory investigations were conducted, including complete blood count (CBC), liver functions, kidney functions, C-reactive protein (CRP), and arterial blood gases (ABG) daily. Also, Glycated hemoglobin (HbA1c), D-Dimer, Procalcitonin (PCT), Ferritin at admission, sodium (Na), and potassium (K) every four hours. In addition to specific laboratory investigations like a cluster of differentiation (CD4/CD8) ratio on admission and interleukin 6 (IL6) on admission and after three days. The patient also had further investigations, such as electrocardiography (ECG).

Regarding imaging, routine studies like abdominal ultrasonography (US) and echocardiography or specific for mucormycosis like CT or magnetic resonance imaging (MRI) for brain and nasal sinuses were conducted. For patients who needed surgical debridement, preoperative viral markers (HCV antibody, HBs antigen, HIV antibody) were drawn, and intraoperative biopsies were taken for histopathological examination. Patients initially received conventional Amphotericin B, while in case of therapy complications, the treatment is converted to liposomal Amphotericin B.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Faculty of Human Medicine, Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with a history of previously cleared COVID-19 infection who were admitted to critical care with newly developed mucormycosis

Description

Inclusion Criteria:

• confirmed previous COVID-19 infection with new mucormycosis infection

Exclusion Criteria:

• other fungal infections post-COVID-19 or mucormycosis infections without previous COVID-19

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	mortality rate of patients with mucormycosis in the critical care	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	complications arise from the treatment with Amphotericin B	48weeks

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ayman Sadek, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mucormycosis; Post COVID-19; Cutaneous infection; Ocular infection; Sinus infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; COVID-19; Mucormycosis; Zygomycosis
• Other Study ID Numbers: ZU-IRB#9491/26-4-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No