Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
covid19
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedOctober 27, 2020
October 1, 2020
1 month
October 21, 2020
October 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
group 1 dexamethasone
ACTIVE COMPARATORparticipants will receive dexamethasone 8mg/day Intravenous for 5 days
group 2 methylprednisolone
ACTIVE COMPARATORparticipants will receive methylprednisolone 1mg/kg/day intravenous for 5 days
Interventions
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatima Memorial Hospital
Lahore, Punjab Province, 54700, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Khurshid A Khan, MBBS, FACM
Fatima Memorial Hospital
- PRINCIPAL INVESTIGATOR
Arzinda F Syeda, MBBS, FCPS
Fatima Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 27, 2020
Study Start
May 30, 2020
Primary Completion
June 30, 2020
Study Completion
July 1, 2020
Last Updated
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
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