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

NCT ID: NCT04603729

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2020-07-01

Brief 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.

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.

Conditions

Covid 19 Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1 dexamethasone

participants will receive dexamethasone 8mg/day Intravenous for 5 days

Group Type: ACTIVE_COMPARATOR

Dexamethasone 2 MG/ML

Intervention Type: DRUG

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

group 2 methylprednisolone

participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days

Group Type: ACTIVE_COMPARATOR

Methylprednisolone Injection

Intervention Type: DRUG

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

Interventions

Dexamethasone 2 MG/ML

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

Intervention Type: DRUG

Methylprednisolone Injection

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

Intervention Type: DRUG

Other Intervention Names

decadron; solumedrol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatima Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Syeda Arzinda Fatima

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khurshid A Khan, MBBS, FACM

Role: STUDY_CHAIR

Fatima Memorial Hospital

Arzinda F Syeda, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Fatima Memorial Hospital

Locations

Fatima Memorial Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

FMH-06-2020-IRB-763-M

Identifier Type: -

Identifier Source: org_study_id