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

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ClinicalTrials.gov Identifier: NCT05062681
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Eman Osama Zayed Mahmoud Rostom, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Pandemic Drug: Dexamethasone Drug: Methylprednisolone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED CONT
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dexamethasone group
Patients will receive dexamethasone 8 mg q12hours
 Drug: Dexamethasone
Patients will receive dexamethasone 8 mg q12hours
Experimental: methylprednisolone group
Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes
 Drug: Methylprednisolone
Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes


Outcome Measures
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Primary Outcome Measures :
  1. 28 days in hospital mortality [ Time Frame: 28 days ]
    all patients who will die in 28 days from the start of treatment


Secondary Outcome Measures :
  1. WHO clinical progression scale [ Time Frame: 10 days ]
    WHO clinical progression scale

  2. Adverse events related to steroids [ Time Frame: 10 days ]
    incidence of infection or hyperglycemia

  3. Duration of ICU stay [ Time Frame: 10 days ]
    Duration of ICU stay

  4. Duration of high oxygen supplementation [ Time Frame: 10 days ]
    Duration of high oxygen supplementation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062681


Contacts
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Contact: Eman Rostom, BSc 01111303366 eman.osama@std.pharma.cu.edu.eg
Contact: Dalaal Moustafa Abdallah, Professor 01222327743 dalaal.abdallah@pharma.cu.edu.eg

Locations
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Egypt
Eman Osama Recruiting
Cairo, Egypt, 11757
Contact: Eman Osama    01111303366    eman.osama@std.pharma.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mohamed EL-Ayashy, Ass. Professor Ass. Professor of Anesthesia and Intensive Care
Study Chair: Mohamed Farouk Abdelsalam, Consultant Consultant of Clinical Pharmacy and Clinical Nutrition Al-Galaa Military Medical Complex (GMMC)
More Information
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Publications:

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Responsible Party: Eman Osama Zayed Mahmoud Rostom, teaching assistant, Cairo University
ClinicalTrials.gov Identifier: NCT05062681    
Other Study ID Numbers: Steroids in COVID-19
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Osama Zayed Mahmoud Rostom, Cairo University:
steroids
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
 Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal