Protocol summary
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Study aim
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The effect of Edaravone on the course of clinical signs in patients with COVID-19 will be evaluated.
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Design
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A clinical trial with a control group, with parallel groups, simple-randomly assigned to intervention and control groups, Phase 3, 38 patients
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Settings and conduct
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This study will be performed in Imam Reza Hospital, Tabriz, Iran. 38 patients will be divided into two groups (15 in each group) by simple randomization. Patients in the control group will be prescribed a standard regimen. Patients in the intervention group, in addition to the treatment approved by the Ministry of Health, will receive 30 mg Edaravone by intravenous infusion for 3 day. Lungs' CT scan, hospitalization period, need to intubation, and mortality rate will be assessed.
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Participants/Inclusion and exclusion criteria
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Patients with COVID-19 with mild to moderate pneumonia; 18 years to 80 Years; both genders. Exclusion criteria: Pregnant or lactating women; patients with an active thrombotic event; severe respiratory failure.
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Intervention groups
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will receive a standard regimen for COVID-19 plus Edaravone. Control group: will receive a standard regimen for COVID-19.
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Main outcome variables
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Symptoms of the disease; mortality rate; hospitalization period
General information
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Reason for update
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According to the conducted changes during the project, editions were made to the inclusion and exclusion criteria, the method of blinding, the number of achieved patients and the drug dose.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200317046797N6
Registration date:
2020-06-18, 1399/03/29
Registration timing:
prospective
Last update:
2022-03-09, 1400/12/18
Update count:
1
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Registration date
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2020-06-18, 1399/03/29
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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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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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2020-12-21, 1399/10/01
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Actual recruitment end date
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2021-08-30, 1400/06/08
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Trial completion date
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empty
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Scientific title
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Effect of edaravone on clinical improvement and outcome of patients with respiratory distress syndrome caused by COVID-19
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Public title
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Edaravone in 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:
Patients with COVID-19-induced pneumonia confirmed with Polymerase chain reaction (PCR)
Patients with COVID-19-induced pneumonia confirmed with chest CT scan results
18 to 80 years old
Patients with acute respiratory distress syndrome (ARDS) according to Berlin ARDS criteria
Exclusion criteria:
Patients who are participating in other drug clinical trials
Pregnant or lactating women
Patient with drug allergy
Patients on mechanical ventilation
Patients with expected survival duration< 24 h
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
30
Actual sample size reached:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization will be generated with a computer from 1 to 38. The computer will divide the digits between the two groups (edaravone and control). According to the sequences of admission, they will go to the control or the intervention group regarding the computerized random list.
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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 packaging of the drugs in this study will be similar to the other drugs related to COVID-19 therapy and the researcher will not be aware from the grouping of patients. Therefore, patients and researchers will be blinded.
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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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2020-05-18, 1399/02/29
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Ethics committee reference number
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IR.TBZMED.REC.1399.128
Health conditions studied
1
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Description of health condition studied
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Patients with COVID-2019
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Hospitalization days
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Timepoint
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At baseline and discharge time
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Method of measurement
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Counting the days
2
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Description
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Need for mechanical ventilation
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Timepoint
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From baseline to discharge time
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Method of measurement
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Observation and documents
3
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Description
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Condition of discharge (death or recovery)
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Timepoint
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End of hospitalization
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Method of measurement
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Observation and documents
Intervention groups
1
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Description
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Intervention group: 15 patients with COVID-19 in addition to a standard regimen will receive 30 mg intravenous infusion edaravone (C10H10N2O, Zist Daroo Co., Iran) every 12 hours for 1 day from the beginning of hospitalization
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Category
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Treatment - Drugs
2
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Description
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Control group: 15 patients will receive only standard regimen of COVID-2019
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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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Tabriz 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