Protocol summary
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Study aim
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1- Determining the effect of Arbidol in the treatment of patients with Coronavirus hospitalized in Firoozgar hospital.
2- Determining the effect of therapy according to guidelines in treatment of patients with Coronavirus.
3- Comparison of effect of treatment of patients with Coronavirus in Firoozgar hospital between control and intervention groups.
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Design
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Two arm parallel group, phase 3 trial, with total sample size of 100, simple randomization using random blocks
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Settings and conduct
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100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age equal or greater than 18 years; Signing a consent form; Diagnosis of COVID-19 by chest CT-scan or RT-PCR test.
Exclusion criteria: People with a history of allergies to this drug and / or a history of severe allergies; ََPatients who used Arbidol (Tablets, capsules, granules) before hospitalization; Women who are breastfeeding or pregnant, Respiratory failure, renal or liver failure, Anemia or thrombocytopenia, Coagulation disorders, patients who received immunosuppressive drugs during 3 months ago, congenital heart disease,, arrhythmia
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Intervention groups
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Patients in the control group will be given a standard treatment regimen including Kaletra (Lopinavir-Ritonavir) and Hydroxychloroquine according to guidlines. Patients in the intervention group will be given oral Hydroxychloroquine with Arbidol orally at a dose of 50 mg 3 times daily for 5 to 10 days.
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Main outcome variables
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Antipyretic rate; Improvement of complete blood count ESR and CRP tests; Virus negative conversion rate; Improvement of blood oxygen saturation and no adjuvant oxygen therapy; Improvement of chest X-Ray symptoms
General information
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Reason for update
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Due to the implementation requirements, the update has been made in accordance with the existing conditions.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180725040596N2
Registration date:
2020-04-18, 1399/01/30
Registration timing:
prospective
Last update:
2020-08-04, 1399/05/14
Update count:
2
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Registration date
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2020-04-18, 1399/01/30
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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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2020-04-29, 1399/02/10
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Expected recruitment end date
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2020-09-22, 1399/07/01
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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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Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19
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Public title
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Effect of Arbidol in 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:
Age equal or greater than 18 years
Signing informed consent
Diagnosis of COVID-19 by chest CT-scan or RT-PCR test
Exclusion criteria:
Respiratory failure
People with a history of allergies to this drug and or a history of severe allergies
Patients who used Arbidol (Tablets, capsules, granules) before hospitalization
Women who are breastfeeding or pregnant
Renal or liver function failure
Anemia or thrombocytopenia
Patient who received immunosuppressive drug during 3 months ago
Congenital heart failure
History of arrhythmia
coagulation disorders
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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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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Method: Simple randomization.
Unit: Individual.
Tools: Random blocks
How to build: Using 4 times Blocks (AABB, ABAB, ....) with random selection of block and reading from right to left
Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2020-04-14, 1399/01/26
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Ethics committee reference number
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IR.IUMS.REC.1399.090
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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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Measurement of patients fever
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Timepoint
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Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Thermometer
2
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Description
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Measurement of complete blood count test
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Timepoint
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Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Blood test
3
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Description
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Determination of C-reactive protein test
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Timepoint
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Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Blood test
4
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Description
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chest CT Scan view symptoms
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Timepoint
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Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment
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Method of measurement
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Taking a chest CT scan
5
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Description
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Measurement of blood oxygen saturation and no adjuvant oxygen therapy
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Timepoint
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Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Pulse oximeter
6
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Description
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hospital admission days
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Timepoint
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check daily
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Method of measurement
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observation
Secondary outcomes
1
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Description
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Measurement of erythrocyte sedimentation rate test
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Timepoint
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Measurement of erythrocyte sedimentation rate at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Blood test
2
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Description
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Observing virological results
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Timepoint
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Measurement of patient's sputum viral load at the beginning of the study and 7 days after starting treatment
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Method of measurement
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Real-time polymerase chain reaction test
3
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Description
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Patient death
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Timepoint
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Check daily
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Method of measurement
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Observation
Intervention groups
1
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Description
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Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 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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Iran University of Medical Sciences
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Proportion provided by this source
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80
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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
2
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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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Presidential Transformation and Development Cooperation Center
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Proportion provided by this source
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20
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data can be shared after patients have become unrecognizable.
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When the data will become available and for how long
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The information access will begin immediately after the results are shared.
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To whom data/document is available
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University researchers and industry professionals will be able to access the data.
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Under which criteria data/document could be used
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Individuals with official letters from research centers, research institutes, research institutes affiliated with the Ministry of Health, as well as scientific research institutes will be able to view without interference.
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From where data/document is obtainable
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Individuals should refer to the Prevention Medicine and Public Health Research Center of Iran University of Medical Sciences located in Tehran, Hemmat Highway, next to Milad Tower, School of Medicine, third floor to Ms. Neda Soleiman Vandi.
Website address: www.pmph.iums.ac.ir
Email: pmph@iums.ac.ir
Phone number: 02186703350
Postal Code: 1449614535
Mailbox: 354-14665
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What processes are involved for a request to access data/document
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By sending an e-mail or sending a letter to the esteemed head of the Prevention Medicine and Public Health Research Center Iran University of Medical Sciences and presenting the reasons for their request so that they will receive the data in less than a month after examining their reasons and during the relevant legal procedure.
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Comments
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