Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease (covid19)
Primary Purpose
Covid 19 Disease
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Dexamethasone 2 MG/ML
Methylprednisolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Covid 19 Disease focused on measuring covid19, dexamethasone, methlprednisolone, corticosteroids
Eligibility Criteria
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
Sites / Locations
- Fatima Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1 dexamethasone
group 2 methylprednisolone
Arm Description
participants will receive dexamethasone 8mg/day Intravenous for 5 days
participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days
Outcomes
Primary Outcome Measures
temperature (F)
reduction in temperature in degree farrenheit
oxygen saturation(%)
reduction in oxygen requirement in lit/min
CRP (mg/dl)
mean reduction in CRP mg/dl in 5 days
mortality
number of patients died
ICU transfer
number of patients shifted to ICU
Secondary Outcome Measures
Full Information
NCT ID
NCT04603729
First Posted
October 21, 2020
Last Updated
October 24, 2020
Sponsor
Fatima Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04603729
Brief Title
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Acronym
covid19
Official Title
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Memorial Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19 Disease
Keywords
covid19, dexamethasone, methlprednisolone, corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1 dexamethasone
Arm Type
Active Comparator
Arm Description
participants will receive dexamethasone 8mg/day Intravenous for 5 days
Arm Title
group 2 methylprednisolone
Arm Type
Active Comparator
Arm Description
participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 2 MG/ML
Other Intervention Name(s)
decadron
Intervention Description
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Other Intervention Name(s)
solumedrol
Intervention Description
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Primary Outcome Measure Information:
Title
temperature (F)
Description
reduction in temperature in degree farrenheit
Time Frame
5 days
Title
oxygen saturation(%)
Description
reduction in oxygen requirement in lit/min
Time Frame
5 days
Title
CRP (mg/dl)
Description
mean reduction in CRP mg/dl in 5 days
Time Frame
5 days
Title
mortality
Description
number of patients died
Time Frame
5 days
Title
ICU transfer
Description
number of patients shifted to ICU
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khurshid A Khan, MBBS, FACM
Organizational Affiliation
Fatima Memorial Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arzinda F Syeda, MBBS, FCPS
Organizational Affiliation
Fatima Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima Memorial Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
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