World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt

NCT06267326 | Completed Phase 1 DMC

• 1 other identifier: Nasser institute
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection

Conditions

Mucormycosis; Rhinocerebral (Etiology); COVID-19

Outcome Measures

Primary Outcomes (3)

• 35 patients suffering from mucormycosis infection post covid 19

  Ratio Scale. Visual Analog Score for pain Ratio Scale. Ratio Scale. ratio scale

  2 years

• 25 patients were cured with comorbidity and 10 pateints died

  ordinal scale Visual Analog Score for pain

  2 years

• pain

  Visual Analog Score for pain

  two years

Secondary Outcomes (1)

• Visual Analog Score for pain

  2years

Study Arms (2)

Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years

OTHER

Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors

Procedure: debridment

Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17

EXPERIMENTAL

Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids. patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients. Hyperbaric oxygen was used in five patients post-surgically. all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal. The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors

Procedure: debridment

Interventions

debridment PROCEDURE

resection of dead bone

Also known as: medication

Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17; Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years

Eligibility Criteria

• Age: 22 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with mucormycosis post covid 19

You may not qualify if:

• The patient not suffered from covid 19

Sponsors & Collaborators

• Nasser Institute For Research and Treatment: lead

Study Sites (1)

Omar Elmonofy

Cairo, Egypt

Location

MeSH Terms

Conditions

Mucormycosis; COVID-19

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 20, 2024
• Study Start: May 23, 2021
• Primary Completion: June 12, 2022
• Study Completion: August 21, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EG (1)