Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease (covid19)

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.

Study Overview

• Status: Completed
• Conditions: Covid 19 Disease
• Intervention / Treatment: Drug: Dexamethasone 2 MG/ML; Drug: Methylprednisolone Injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54700
      • Fatima Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 dexamethasone; participants will receive dexamethasone 8mg/day Intravenous for 5 days	Drug: Dexamethasone 2 MG/ML; Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants; Other Names: decadron
Active Comparator: group 2 methylprednisolone; participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days	Drug: Methylprednisolone Injection; methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants; Other Names: solumedrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
temperature (F)	reduction in temperature in degree farrenheit	5 days
oxygen saturation(%)	reduction in oxygen requirement in lit/min	5 days
CRP (mg/dl)	mean reduction in CRP mg/dl in 5 days	5 days
mortality	number of patients died	5 days
ICU transfer	number of patients shifted to ICU	5 days

Collaborators and Investigators

• Sponsor: Fatima Memorial Hospital
• Investigators: Study Chair: Khurshid A Khan, MBBS, FACM, Fatima Memorial Hospital; Principal Investigator: Arzinda F Syeda, MBBS, FCPS, Fatima Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: covid19; dexamethasone; corticosteroids; methlprednisolone
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: FMH-06-2020-IRB-763-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: patient name and medical record will be confidential, onle the principal investigator will have access to data. Results of study will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No