Skip to main content
OpenTrials
Completed

NCT Number: NCT04603729

Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease

The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fatima Memorial Hospital

Lahore, Punjab Province, 54700, Pakistan

About this study

The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs were sent, initial level of CRP (C-reactive protein) was noted down.

Patients with oxygen saturation < 94% on room air with normal chest x-ray and CRP between 30 - 50, were labelled as having moderate covid 19 disease. Patients with CRP> 50 and having infiltrates on chest x-ray at the time of admission were considered having severe covid 19 disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.

Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition deteriorated and/or mechanical ventilation is needed.

The investigator noted the improvement in clinical, radiological and biochemical parameters of the patient on day 0 that is admission day and later on day 5 after giving steroids (methylprednisolone or dexamethasone) for 5 days.

Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means were calculated. Paired sample t-test was applied for comparison of the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 75 years
  • Covid PCR positive
  • Patient having oxygen saturation < 94% on room air, regardless of chest x-ray findings
  • Moderate or severe covid 19 disease according to operational definition.
  • Patients who sign informed consent.

Exclusion criteria

  • Severe immunosuppression like HIV( Human immunodeficiency Virus) or long term use of immunosuppressant for any other chronic illness
  • Patients who need corticosteroids for any other disease like asthma, rheumatoid arthritis.
  • Pregnant or lactating females

Treatment and study plan

Dexamethasone 2 MG/ML

Drug

Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants

Other names: decadron

Methylprednisolone Injection

Drug

methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants

Other names: solumedrol

Primary outcomes

  1. temperature (F)

    Time frame: 5 days

    reduction in temperature in degree farrenheit

  2. oxygen saturation(%)

    Time frame: 5 days

    reduction in oxygen requirement in lit/min

  3. CRP (mg/dl)

    Time frame: 5 days

    mean reduction in CRP mg/dl in 5 days

  4. mortality

    Time frame: 5 days

    number of patients died

  5. ICU transfer

    Time frame: 5 days

    number of patients shifted to ICU

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Acronym: covid19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2020
Registry last updated
Oct 27, 2020

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.

Published trials that share one or more normalized conditions with this study.