RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

Phase 4

• Conditions: COVID-19 Pandemic
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT05062681
• Lead Sponsor: Cairo University

Brief Summary

This study aims to evaluate the therapeutic activity and side effects of 16 mg/day dexamethasone in comparison to equivalent dose of MP (1mg/kg/day)for the management of COVID-19 infected patients.Moreover, and according to the importance of the IL-6/STAT-3 in triggering the inflammatory cascade and as the miRNAs are considered as prognostic markers, hence, the study aims also to study the impact of the used regimens on these biomarkers

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-15
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-28
• Last Update Submitted: 2021-09-28
• Study First Posted: 2021-09-30
• Last Update Posted: 2021-09-30
• Primary Completion: 2021-12-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult (≥18 years of age) at time of enrolment
2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing)
3. Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask
4. Admission to ICU in the last 24 hours

Exclusion Criteria

• 1- Underlying disease requiring chronic corticosteroids 2- Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrollment 3- Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock) 4-Any contraindication for corticosteroid administration 5-Cardiac arrest before ICU admission 6-Pregnancy or breast feeding 7- Immunocompromised patients as cancer (active) patients, patients on chemotherapy or radiotherapy, HIV, and transplant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone	Patients will receive dexamethasone 8 mg q12hours
methylprednisolone group	Methylprednisolone	Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Primary Outcome Measures

Name	Time	Method
28 days in hospital mortality	28 days	all patients who will die in 28 days from the start of treatment

Secondary Outcome Measures

Name	Time	Method
WHO clinical progression scale	10 days	WHO clinical progression scale
Adverse events related to steroids	10 days	incidence of infection or hyperglycemia
Duration of ICU stay	10 days	Duration of ICU stay
Duration of high oxygen supplementation	10 days	Duration of high oxygen supplementation

Trial Locations

Locations (1)

Eman Osama; 🇪🇬 Cairo, Egypt