Study of application of amphotericin into the nose for prevention of fungal infection in COVID positive patients

Phase 4

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/07/034543
• Lead Sponsor: Department of ENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

pre-existing diabetes mellitus at the time of admission

- in those without diagnosed diabetes at baseline, a fasting or random blood glucose level > 200 mg/ dl at any time point during admission

- patients who have received >=6 mg/day of Dexamethasone or >=30mg/day of methylprednisolone

- patients receiving immunomodulators for at least 24 hours

- patients receiving systemic anti-bacterial drugs

- patients with hematologic malignancies

- receiving bone marrow transplant/ systemic chemotherapy/ HIV-AIDS/ immunosuppressive therapy after organ transplant

Exclusion Criteria

1. COVID 19 patients with evidence of mucor mycosis at screening or randomization

2. COVID 19patients with features of invasive fungal sinusitis at screening or randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of COVID positive patients at risk for invasive fungal sinusitis developing mucor mycosisTimepoint: 14 days

Secondary Outcome Measures

Name	Time	Method
Proportion of COVID positive patients at risk for invasive fungal sinusitis developing mucor mycosisTimepoint: 28 days