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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: COVID-19 Pandemic

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05062681

Steroids in COVID-19

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Dexamethasone group

Active Comparator group

Description:

Patients will receive dexamethasone 8 mg q12hours

Treatment:

Drug: Dexamethasone

methylprednisolone group

Experimental group

Description:

Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Treatment:

Drug: Methylprednisolone