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.
Design
Two arm parallel group, phase 3 trial, with total sample size of 100, simple randomization using random blocks
Settings and conduct
100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control. Patients and doctors will be blinded.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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 4 times daily for 5 to 10 days.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040596N2
Registration date:2020-04-18, 1399/01/30
Registration timing:prospective
Last update:2020-04-18, 1399/01/30
Update count:2
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Nasir Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 5162
Email address
dehghan.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19
Public title
Effect of Arbidol in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in School of Medicine, Iran University of Medical Sciences
Street address
13th Floor, Block A, between South Felamak and Zarafshan, Iran-Iran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.IUMS.REC.1399.090
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Improvement of patients fever
Timepoint
Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment
Method of measurement
Thermometer
2
Description
Improvement of complete blood count test
Timepoint
Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
3
Description
Improvement of C-reactive protein test
Timepoint
Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
4
Description
Improvement of chest X-Ray symptoms
Timepoint
Examination of patient's chest x-ray at the beginning of the study and 7 days after starting treatment
Method of measurement
Taking a chest x-ray
5
Description
Improvement of blood oxygen saturation and no adjuvant oxygen therapy
Timepoint
Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Improvement of erythrocyte sedimentation rate test
Timepoint
Measurement of erythrocyte sedimentation rate at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
2
Description
Virus negative conversion rate
Timepoint
Measurement of patient's sputum viral load at the beginning of the study and 7 days after starting treatment
Method of measurement
Real-time polymerase chain reaction test
Intervention groups
1
Description
Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine 400 mg single dose and Arbidol orally at a dose of 50 mg 4 times a day for 5 to 10 days.
Category
Treatment - Drugs
2
Description
Control group: Sixty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and two Hydroxychloroquine sulfate 200 mg tablets as a single dose for 5 to 10 days.
Iran University of Medical Sciences., Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 2225
Email
mnojomi@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Nojomi
Position
Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Fax
+98 21 8860 2217
Email
mnojomi@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients have become unrecognizable.
When the data will become available and for how long
The information access will begin immediately after the results are shared.
To whom data/document is available
University researchers and industry professionals will be able to access the data.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.