Protocol summary
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Study aim
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This study will be performed to determine the efficacy of Arbidol and the standard treatment regimen according to national guidelines and compare their effectiveness in treating outpatients with COVID-19.
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Design
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A phase II, two-arm, parallel, randomized, double-blind, controlled clinical trial on 100 COVID-19 outpatients. For randomization, random blocks will be used.
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Settings and conduct
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This study will be performed on outpatients with COVID-19 in an outpatient clinic under infectious disease specialists' supervision. After confirmation of the disease with the rt-PCR test and, if the patients meet the inclusion criteria, they will be randomly assigned to one of the two groups. Also, the participants and some of the researchers will be blinded.
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Participants/Inclusion and exclusion criteria
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Patients with the new coronavirus infection 2019 (COVID-19) confirmed by the rt-PCR test with the approval of an infectious disease specialist and an indication for outpatient treatment will randomly be allocated into two groups: intervention group (Arbidol plus standard treatment) and control group (standard treatment).
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Intervention groups
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The control group will be given standard treatment, including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone propionate inhaler, and the intervention group will also receive the standard regimen plus two capsules of arbidol (manufactured by Pharmstandard, Russia) with the dose of 40 mg q8hours. Treatment in both groups will continue for 7 days.
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Main outcome variables
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Cessation of fever; Improve ESR, CRP, and CBC test results; Negative rt-PCR test; Improve oxygen saturation; No need for mechanical ventilation; Improve pulmonary involvement on CT scan
General information
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Reason for update
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To change the patient recruitment date, phase of the study, and sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201024049134N1
Registration date:
2020-11-02, 1399/08/12
Registration timing:
prospective
Last update:
2021-01-17, 1399/10/28
Update count:
1
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Registration date
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2020-11-02, 1399/08/12
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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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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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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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Efficacy of standard and Arbidol treatments in COVID-19 outpatients
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Public title
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Efficacy 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:
People over the age of 65 who are in high-risk groups (with a history of high blood pressure, diabetes, BMI> 30, COPD, cancer, and etc.)
Confirmation of the diagnosis of COVID-19 by chest CT scan and/or rt-PCR
Signing an informed consent form
Exclusion criteria:
History of allergies to these drugs
Use arbidol before hospitalization
Pregnant women
Respiratory failure and need for mechanical ventilation
Renal and/or hepatic failure
Anemia and thrombocytopenia
Coagulopathy
Autoimmune or immune deficiency disorders
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Age
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From 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Unit randomization is done by block method with a block size of 4. For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows
AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6)
With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number.
To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission.
Tools: Create random sequences of 4 random blocks
Concealment to execute random sequences on study participants
will be done.
How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are 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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Double blinded
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Blinding description
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In this study, patients and some researchers who act as clinicians, and statisticians will be blinded.
Names of the researchers for whom blinding will be performed:
1) Mostafa Javanian
2) Masoumeh Bayani
3) Mahmoud Sadeghi-Haddad-Zavareh
4) Mehran Shokri
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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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2020-08-22, 1399/06/01
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Ethics committee reference number
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IR.MUBABOL.REC.1399.283
Health conditions studied
1
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Description of health condition studied
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
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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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Time of the removal of the symptoms
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Timepoint
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Up to 1 month after the end of the study
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Method of measurement
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Examination of the patients by infectious disease specialists in an outpatient clinic
2
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Description
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hospitalization required
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Timepoint
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Up to 1 month after the end of the study
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Method of measurement
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Examination of the patients by infectious disease specialists in an outpatient clinic
3
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Description
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Life-threatening conditions
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Timepoint
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Up to 1 month after the end of the study
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Method of measurement
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Examination of the patients by infectious disease specialists in an outpatient clinic
4
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Description
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Death
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Timepoint
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Up to 1 month after the end of the study
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Method of measurement
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Examination of the patients by infectious disease specialists in an outpatient clinic
Intervention groups
1
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Description
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Control group: standard approved treatment regimen for COVID-19, including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone inhaler for 7 days
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Category
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Treatment - Drugs
2
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Description
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Intervention group: standard approved treatment regimen for COVID-19, including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone inhaler plus arbidol (manufactured by Pharmstandard, Russia) at the dose of two 40 mg capsules every 8 hours for 7 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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Babol 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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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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No - There is not a plan to make this available
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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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All participants' personal data can be shared after unidentifying individuals.
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When the data will become available and for how long
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Six months after the end of the study and publication of the article
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To whom data/document is available
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The data of this study will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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There are no specific preconditions.
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From where data/document is obtainable
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They should send their request to the person in charge of the study, Dr. Mostafa Javanian, with the e-mail address: mjavanian@gmail.com
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What processes are involved for a request to access data/document
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On average, it will take two weeks to process the application.
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Comments
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