Protocol summary
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Study aim
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To assess the effect of intravenous hydrocortisone, methylprednisolone, and dexamethasone in the treatment of patients with moderate to severe acute respiratory distress syndrome caused by COVID-19
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Design
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This is a double-blind randomized clinical trial, phase II, in which 81 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with moderate to severe acute respiratory distress syndrome caused by COVID-19 referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 70 years,
Hospitalized in the intensive care unit in less than past 48 hours,
Mild to moderate acute respiratory distress syndrome due to COVID-19,
Bilateral pulmonary infiltration in chest X-ray or CT-scan,
Respiratory distress with more than 24 breathe per minute
Exclusion criteria:
Pregnancy or breastfeeding,
Cardiopulmonary edema,
Severe acute respiratory distress syndrome,
Using antioxidant drugs,
Chronic liver or renal disease,
Contraindication of N-acetyl cysteine
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Intervention groups
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Intervention group 1:
Routine care plus intravenous hydrocortisone 50 mg every 8 hours for 10 days
Intervention group 2:
Routine care plus intravenous methylprednisolone 16 mg every 12 hours for 10 days
Intervention group 3:
Routine care plus intravenous dexamethasone 6 mg daily for 10 days
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Main outcome variables
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Primary outcome:
Need to mechanical ventilation, the patient's clinical status, the mortality rate
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N354
Registration date:
2020-05-12, 1399/02/23
Registration timing:
prospective
Last update:
2022-04-26, 1401/02/06
Update count:
1
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Registration date
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2020-05-12, 1399/02/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-04, 1399/03/15
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Expected recruitment end date
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2020-08-05, 1399/05/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of intravenous hydrocortisone, methylprednisolone, and dexamethasone in treatment of patients with moderate to severe acute respiratory distress syndrome caused by COVID-19: A double blind randomized clinical trial
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Public title
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Evaluating the effect of intravenous hydrocortisone, methylprednisolone, and dexamethasone in treatment of patients with moderate to severe acute respiratory distress syndrome caused by COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 70 years,
Hospitalized in intensive care unit in less than past 48 hours,
Mild to moderate acute respiratory distress syndrome due to COVID-19,
Bilateral pulmonary infiltration in chest X-ray or CT-scan,
Respiratory distress with more than 24 breathe per minute
Exclusion criteria:
Pregnancy or breastfeeding,
Cardiopulmonary edema,
Severe acute respiratory distress syndrome,
Using antioxidant drugs,
Chronic liver or renal disease,
Contraindication of N-acetyl cysteine
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
81
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of intervention 3. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-09, 1399/02/20
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Ethics committee reference number
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IR.UMSHA.REC.1399.152
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Need to mechanical ventilation
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Timepoint
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Within 28 days after the intervention
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Method of measurement
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By physical examination
2
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Description
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The patient's clinical status
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Timepoint
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Within 28 days after the intervention
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Method of measurement
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Based on the World Health Organization's 7-score system
3
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Description
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Mortality rate
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Timepoint
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Within 28 days after the intervention
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Method of measurement
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Based on medical document
Intervention groups
1
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Description
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Intervention group 1: Routine care plus intravenous hydrocortisone 50 mg every 8 hours for 10 days
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Routine care plus intravenous methylprednisolone 16 mg every 12 hours for 10 days
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: Routine care plus intravenous dexamethasone 6 mg daily for 10 days
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available