Protocol summary
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Study aim
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Evaluation of Methylprednisolone effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients
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Design
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This study is a two arm parallel group, single blinded clinical trial in phase 2 which will be carried out on 68 hospitalized COVID-19 patients. Patients randomly divided into two groups.
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Settings and conduct
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68 hospitalized COVID-19 patients in Shariati and Imam khomeini hospital and Isfahan medical university will be included in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: COVID-19 patient with confirmed by positive PCR test for SARS-CoV-2 or abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), Blood oxygen saturation <93%, Respiratory Rat >30 breaths/minute, before connecting to ventilator and intubation. Exclusion criteria: Patients with uncontrolled type I diabetes and blood pressure and positive pro-calcitonin or active infection, and taking any immune-suppressor agents.
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Intervention groups
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Control group: will receive standard regimen for COVID-19. Methylprednisolone group: will receive standard regimen for COVID-19 plus Methylprednisolone (250mg for 3 days).
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Main outcome variables
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This clinical trial will be carried out on 68 hospitalized COVID-19 patients in Shariati and Imam khomeini hospital of Tehran and Isfahan medical university, Iran. Patients will be received 250mg methylprednisolone pulse for 3 days. In this study, patients don't know which group of them will use the medicine. Physician and clinicians team know about the medicine and intervention groups.
General information
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Reason for update
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update the blindness, randomization of the study, sample size and the time of clinical record
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200404046947N1
Registration date:
2020-04-15, 1399/01/27
Registration timing:
registered_while_recruiting
Last update:
2020-05-22, 1399/03/02
Update count:
1
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Registration date
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2020-04-15, 1399/01/27
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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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2020-03-28, 1399/01/09
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Expected recruitment end date
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2020-05-28, 1399/03/08
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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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Study of Methylprednisolone effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study
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Public title
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Effect of Methylprednisolone on treatment of 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:
COVID-19 patient confirmed by positive PCR test for SARS-CoV-2 or abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), Blood oxygen saturation <93%, Respiratory Rate >30 breaths/minute, before connecting to ventilator and intubation.
Exclusion criteria:
Patients with uncontrolled type I diabetes, blood pressure, positive pro-calcitonin, active infection, and taking any immune-suppressor agents, will exclude from the study.
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Age
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From 18 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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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study patients don't know which group of them will use the medicine. Physician and clinicians team know about the medicine and intervention groups.
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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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This study is double blinded clinical trial in phase 2 which will be carried out on 68 hospitalized COVID-19 patients. Patients randomly divided into two groups. Control group and treatment group which received of medicine (250 mg methylprednisolone pulse for 3 days). Clinical signs of patient including heart rate, blood pressure body temperature, O2 saturation, laboratory tests result (CBC, ESR, CRP, VBG, IL-6, Ferritin, Troponin, D-dimer) will be recorded before and after treatment (after 3 days of treatment and at discharge time). In addition, dyspnea, cough, GI Symptom, myalgia, chest pain and BORG Score will be assessed before and after treatment (after 3 days of treatment and at discharge time). Need an oxygen therapy (nasal Cannula, mask Oxygen, reserve Mask, NIV and invasive ventilation) will also be recorded before and after treatment (after 3 days of treatment and at discharge time).
Ethics committees
1
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Ethics committee
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Approval date
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2020-03-27, 1399/01/08
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.054
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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ICD-10 code
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U07.2, U07
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Radiographic features Findings
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Timepoint
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Before and at discharge time only in patients agreed to give informed consent
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Method of measurement
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CT scan
2
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Description
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Mortality rate
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Timepoint
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Before and after
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Method of measurement
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Observation
3
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Description
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O2 saturation
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Timepoint
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Before and after ( by 3 days of treatment and at discharge)
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Method of measurement
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Pulse Oximeter
4
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Description
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Need an oxygen therapy
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Timepoint
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Before and after (at day 3 and discharge time)
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Method of measurement
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clinical
Secondary outcomes
1
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Description
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laboratory tests
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Timepoint
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Before and after (at day 3, and discharge time)
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Method of measurement
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Para-clinical
Intervention groups
1
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Description
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Intervention group: Patients hospitalized with COVID-19 disease who in addition to their standard treatment will be received 250mg/day Methylprednisolone for 3 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients hospitalized with COVID-19 disease who are received standard treatment
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Category
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Treatment - Other
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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Tehran 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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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It will be published as an article
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When the data will become available and for how long
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After printing the article
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To whom data/document is available
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All medical professionals and scientiscts
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Under which criteria data/document could be used
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There is no restriction on access to information
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From where data/document is obtainable
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Dr. Abdorahman Rostamian, Tehran University of Medical Science
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What processes are involved for a request to access data/document
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Refer to the project supervisor
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Comments
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