Clinical trial NCT05911035: Post-COVID-19 Mucormycosis in Critical Care
Official title: Post COVID-19 Acute Mucormycosis in Critical Care Settings in Egypt: A Single-Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucormycosis; Rhinocerebral (Etiology)
Post COVID-19 Condition, Unspecified
Keywords: Mucormycosis
Post COVID-19
Cutaneous infection
Ocular infection
Sinus infection
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-06-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 48 weeks
Secondary outcomes:
measure: Complications
timeFrame: 48weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Human Medicine, Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Ayman Sadek, MD
role: PRINCIPAL_INVESTIGATOR
References: