Clinical trial NCT05062681: RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
Official title: Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19 Pandemic
Keywords: steroids
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONT
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 28 days in hospital mortality
timeFrame: 28 days
Secondary outcomes:
measure: WHO clinical progression scale
timeFrame: 10 days
measure: Adverse events related to steroids
timeFrame: 10 days
measure: Duration of ICU stay
timeFrame: 10 days
measure: Duration of high oxygen supplementation
timeFrame: 10 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Eman Osama
Study officials:
affiliation: Ass. Professor of Anesthesia and Intensive Care
name: Mohamed EL-Ayashy, Ass. Professor
role: STUDY_DIRECTOR
affiliation: Consultant of Clinical Pharmacy and Clinical Nutrition Al-Galaa Military Medical Complex (GMMC)
name: Mohamed Farouk Abdelsalam, Consultant
role: STUDY_CHAIR
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