Impact of Steroids on Inflammatory Response in Covid-19

September 4, 2021 updated by: Omar Makram Soliman, Assiut University

The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU

we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Patients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, Assuit universi
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (age 18-no limit years) who will be diagnosed covid-19
  • With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Exclusion Criteria:

  • Severe immunosuppression like HIV (Human immunodeficiency Virus)
  • Long term use of immunosuppressant for any other chronic illness
  • Pregnant or lactating females
  • Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: (Group D )Dexamethasone
Intravenous dexamethasone 8 mg/day given for 7 days
Drug: Dexamethasone
Baseline laboratory & clinical data will be taken before and after the study drugs according to our protocol.Intravenous dexamethasone 8 mg/day given for 7 days
Other Names:
  • Decadron
EXPERIMENTAL: (Group M) methylprednisolone
Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
Drug: Methylprednisolone
Baseline laboratory & clinical data will be taken before and after the study drugs according to our protocol. Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
Other Names:
  • Solu-medrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil/lymphocyte ratio (NLR)
Time Frame: 7 days
Monitoring of systemic inflammation by follow up of neutrophil/lymphocyte ratio (NLR) at days 0, 48 hour, 72 hour and at day 7 between the two study drugs
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6 (IL-6) level
Time Frame: 7days
Serum level of IL-6 is taken before start drug study &at 7 days to assess inflammatory and immune response
7days
C-reactive protein (CRP) test
Time Frame: 3 days
CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response
3 days
Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)
Time Frame: 3 days
Assessing p/f ratio from arterial blood gas to monitor oxygenation & need for upgrading of oxygen, this is monitored before start of study drugs,at 48 hour and 72 hour
3 days
ICU stay
Time Frame: 7 days
Period of patients admission in the ICU
7 days
ICU mortality
Time Frame: 7days
Short-term icu mortality (7 days) for patients will be expired
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Omar Soliman, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2021

Primary Completion (ACTUAL)

August 15, 2021

Study Completion (ACTUAL)

August 20, 2021

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (ACTUAL)

June 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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