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Impact of Steroids on Inflammatory Response in Covid-19

A

Assiut University

Status and phase

Completed
Phase 3

Conditions

Covid19

Treatments

Drug: Methylprednisolone
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04909918
17300610

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

(Group D )Dexamethasone
Experimental group
Description:
Intravenous dexamethasone 8 mg/day given for 7 days
Treatment:
Drug: Dexamethasone
(Group M) methylprednisolone
Experimental group
Description:
Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
Treatment:
Drug: Methylprednisolone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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