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

NCT05062681 | Unknown Phase 4 DMC

• 1 other identifier: Steroids in COVID-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Pandemic

Keywords

steroids

Outcome Measures

Primary Outcomes (1)

• 28 days in hospital mortality

  all patients who will die in 28 days from the start of treatment

  28 days

Secondary Outcomes (4)

• WHO clinical progression scale

  10 days

• Adverse events related to steroids

  10 days

• Duration of ICU stay

  10 days

• Duration of high oxygen supplementation

  10 days

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Patients will receive dexamethasone 8 mg q12hours

Drug: Dexamethasone

methylprednisolone group

EXPERIMENTAL

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

Drug: Methylprednisolone

Interventions

Dexamethasone DRUG

Patients will receive dexamethasone 8 mg q12hours

Dexamethasone group

Methylprednisolone DRUG

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

methylprednisolone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Eman Osama

Cairo, 11757, Egypt

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

COVID-19

Interventions

Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Study Officials

• Mohamed EL-Ayashy, Ass. Professor

  Ass. Professor of Anesthesia and Intensive Care

  STUDY DIRECTOR

• Mohamed Farouk Abdelsalam, Consultant

  Consultant of Clinical Pharmacy and Clinical Nutrition Al-Galaa Military Medical Complex (GMMC)

  STUDY CHAIR

Central Study Contacts

Eman Rostom, BSc

CONTACT

01111303366; eman.osama@std.pharma.cu.edu.eg

Dalaal Moustafa Abdallah, Professor

CONTACT

01222327743; dalaal.abdallah@pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Model Details: RANDOMIZED CONT

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 30, 2021
• Study Start: September 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: March 15, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

EG (1)