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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05062681

Enrollment

Registered

2021-09-30

Start date

2021-09-15

Completion date

2022-03-15

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pandemic

Keywords

steroids

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

Interventions

DRUGDexamethasone

Patients will receive dexamethasone 8 mg q12hours

DRUGMethylprednisolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

RANDOMIZED CONT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
28 days in hospital mortality	28 days	all patients who will die in 28 days from the start of treatment

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactEman Rostom, BSc

eman.osama@std.pharma.cu.edu.eg01111303366

Backup ContactDalaal Moustafa Abdallah, Professor

dalaal.abdallah@pharma.cu.edu.eg01222327743

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026