Impact of Steroids on Inflammatory Response in Covid-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2021-08-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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(Group D )Dexamethasone

Intravenous dexamethasone 8 mg/day given for 7 days

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

(Group M) methylprednisolone

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

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Decadron Solu-medrol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No