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

Covid 19 Disease Clinical Trial

— covid19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603729
• Other study ID #: FMH-06-2020-IRB-763-M
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2020
• Source: Fatima Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid 19 Disease

Intervention

Drug:
• Dexamethasone 2 MG/ML
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
• Methylprednisolone Injection
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants

Locations

Country	Name	City	State
Pakistan	Fatima Memorial Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Fatima Memorial Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

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