Impact of Steroids on Inflammatory Response in Covid-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04909918
• Other study ID #: 17300610
• Status: Completed
• Phase: Phase 3
• Start date: May 28, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 20, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

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