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Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease (covid19)

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ClinicalTrials.gov Identifier: NCT04603729
Recruitment Status : Completed
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Syeda Arzinda Fatima, Fatima Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Covid 19 Disease Drug: Dexamethasone 2 MG/ML Drug: Methylprednisolone Injection Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Actual Study Start Date : May 30, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : July 1, 2020


Arm Intervention/treatment
Active Comparator: group 1 dexamethasone
participants will receive dexamethasone 8mg/day Intravenous for 5 days
Drug: Dexamethasone 2 MG/ML
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
Other Name: decadron

Active Comparator: group 2 methylprednisolone
participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days
Drug: Methylprednisolone Injection
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Other Name: solumedrol




Primary Outcome Measures :
  1. temperature (F) [ Time Frame: 5 days ]
    reduction in temperature in degree farrenheit

  2. oxygen saturation(%) [ Time Frame: 5 days ]
    reduction in oxygen requirement in lit/min

  3. CRP (mg/dl) [ Time Frame: 5 days ]
    mean reduction in CRP mg/dl in 5 days

  4. mortality [ Time Frame: 5 days ]
    number of patients died

  5. ICU transfer [ Time Frame: 5 days ]
    number of patients shifted to ICU



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603729


Locations
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Pakistan
Fatima Memorial Hospital
Lahore, Punjab, Pakistan, 54700
Sponsors and Collaborators
Fatima Memorial Hospital
Investigators
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Study Chair: Khurshid A Khan, MBBS, FACM Fatima Memorial Hospital
Principal Investigator: Arzinda F Syeda, MBBS, FCPS Fatima Memorial Hospital
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Responsible Party: Syeda Arzinda Fatima, Assistant Professor, Fatima Memorial Hospital
ClinicalTrials.gov Identifier: NCT04603729    
Other Study ID Numbers: FMH-06-2020-IRB-763-M
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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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
Keywords provided by Syeda Arzinda Fatima, Fatima Memorial Hospital:
covid19
dexamethasone
methlprednisolone
corticosteroids
Additional relevant MeSH terms:
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Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents