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Impact of Steroids on Inflammatory Response in Covid-19

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Dexamethasone

Methylprednisolone

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

(Group D )Dexamethasone

(Group M) methylprednisolone

Arm Description

Intravenous dexamethasone 8 mg/day given for 7 days

Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days

Outcomes

Primary Outcome Measures

Neutrophil/lymphocyte ratio (NLR)

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

Secondary Outcome Measures

Interleukin-6 (IL-6) level

Serum level of IL-6 is taken before start drug study &at 7 days to assess inflammatory and immune response

C-reactive protein (CRP) test

CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response

Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)

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

ICU stay

Period of patients admission in the ICU

ICU mortality

Short-term icu mortality (7 days) for patients will be expired

Full Information

NCT ID

NCT04909918

First Posted

May 30, 2021

Last Updated

September 4, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04909918

Brief Title

Impact of Steroids on Inflammatory Response in Covid-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 28, 2021 (Actual)

Primary Completion Date

August 15, 2021 (Actual)

Study Completion Date

August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

(Group D )Dexamethasone

Arm Type

Experimental

Arm Description

Intravenous dexamethasone 8 mg/day given for 7 days

Arm Title

(Group M) methylprednisolone

Arm Type

Experimental

Arm Description

Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Other Intervention Name(s)

Solu-medrol

Intervention Description

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

Primary Outcome Measure Information:

Title

Neutrophil/lymphocyte ratio (NLR)

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Interleukin-6 (IL-6) level

Description

Serum level of IL-6 is taken before start drug study &at 7 days to assess inflammatory and immune response

Time Frame

7days

Title

C-reactive protein (CRP) test

Description

CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response

Time Frame

3 days

Title

Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)

Description

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

Time Frame

3 days

Title

ICU stay

Description

Period of patients admission in the ICU

Time Frame

7 days

Title

ICU mortality

Description

Short-term icu mortality (7 days) for patients will be expired

Time Frame

7days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar Soliman

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assiut university hospital

City

Assiut

State/Province

Assuit

ZIP/Postal Code

Assuit universi

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32714336

Citation

Polidoro RB, Hagan RS, de Santis Santiago R, Schmidt NW. Overview: Systemic Inflammatory Response Derived From Lung Injury Caused by SARS-CoV-2 Infection Explains Severe Outcomes in COVID-19. Front Immunol. 2020 Jun 26;11:1626. doi: 10.3389/fimmu.2020.01626. eCollection 2020.

Results Reference

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Impact of Steroids on Inflammatory Response in Covid-19

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