Impact of Steroids on Inflammatory Response in Covid-19

Phase 3

Completed

• Conditions: Covid19
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT04909918
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2021-05-28
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-02
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-04
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
ICU stay	7 days	Period of patients admission in the ICU
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
C-reactive protein (CRP) test	3 days	CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response
ICU mortality	7days	Short-term icu mortality (7 days) for patients will be expired

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt