Clinical trial NCT04603729: Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Official title: Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid 19 Disease
Keywords: covid19
dexamethasone
methlprednisolone
corticosteroids
Lead sponsor: Fatima Memorial Hospital
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: temperature (F)
timeFrame: 5 days
measure: oxygen saturation(%)
timeFrame: 5 days
measure: CRP (mg/dl)
timeFrame: 5 days
measure: mortality
timeFrame: 5 days
measure: ICU transfer
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital
state: Punjab
Study officials:
affiliation: Fatima Memorial Hospital
name: Khurshid A Khan, MBBS, FACM
role: STUDY_CHAIR
affiliation: Fatima Memorial Hospital
name: Arzinda F Syeda, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: