Impact of Steroids on Inflammatory Response in Covid-19

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT04909918

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

21.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Dexamethasone Drug: Methylprednisolone	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 28, 2021

Actual Primary Completion Date :

Aug 15, 2021

Actual Study Completion Date :

Aug 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Neutrophil/lymphocyte ratio (NLR) [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

Secondary Outcome Measures

Interleukin-6 (IL-6) level [7days]
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 [3 days]
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) [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
ICU stay [7 days]
Period of patients admission in the ICU
ICU mortality [7days]
Short-term icu mortality (7 days) for patients will be expired

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.