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NCT Number: NCT04909918

Impact of Steroids on Inflammatory Response in Covid-19

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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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

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

Other names: Decadron

methylprednisolone

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

Other names: Solu-medrol

Primary outcomes

  1. Neutrophil/lymphocyte ratio (NLR)

    Time frame: 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 outcomes

  1. Interleukin-6 (IL-6) level

    Time frame: 7days

    Serum level of IL-6 is taken before start drug study &at 7 days to assess inflammatory and immune response

  2. C-reactive protein (CRP) test

    Time frame: 3 days

    CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response

  3. Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)

    Time frame: 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

  4. ICU stay

    Time frame: 7 days

    Period of patients admission in the ICU

  5. ICU mortality

    Time frame: 7days

    Short-term icu mortality (7 days) for patients will be expired

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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