Protocol summary
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Study aim
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Evaluation of the effects of the 2-drug diet (Hydroxy chloroquine + umifenovir (Arbidol)) compared with Hydroxy chlorquine on the of mortality rate in patients with moderate symptoms of COVID-19 infections
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Design
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Clinical trial with a control and parallel group design of 100 patients, blinded, and randomized
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Settings and conduct
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This clinical trial is conducted on patients definitively diagnosed with COVID-19 with moderate symptoms. Patients with the inclusion criteria will be randomly assigned to the intervention and control group. The intervention group will receive a two-drug diet of Hydroxy chloroquine and Arbidol. Patients of the control group are selected from those who are routinely receiving Hydroxy chloroquine in Imam Reza Hospital and are similar to patients in the intervention group in terms of sex, age, sickness severity etc. The results of these two groups will be compared.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age range within 18 to 65; definitive diagnosis with COVID-19 with moderate symptoms; SpO2<93%; pulmonary infiltration. Non-inclusion criteria: pregnancy; having morbidities such as heart diseases; history of retinopathy; patient with severe conditions who will not last more than 48 hours; infection with HIV
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Intervention groups
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Intervention group: In this group, patients with moderate symptoms of COVID-19 take the two-drug diet of 200 mg Hydroxy chlorquine with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days in addition to 100 mg Arbidol every 8 hours 2 tablets for at least 7 days.
Control group: patients in this group routinely receive 200 mg Hydroxy chlorquine with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days.
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Main outcome variables
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Fever; respiration rate; pulse rate, SpO2, WBC, number of lymphocytes; LDH; C reactive protein (CRP), findings of CT scan
General information
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Reason for update
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Considering the increase in the volume of the drug received from the ministry of health and also increase in the number of patients infected by COVID-19, the university vice dean for research decided to increase the sample size and at this moment, the randomized study is, with the permission of ethics committee, being conducted.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200325046859N2
Registration date:
2020-04-26, 1399/02/07
Registration timing:
registered_while_recruiting
Last update:
2020-06-12, 1399/03/23
Update count:
1
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Registration date
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2020-04-26, 1399/02/07
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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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2020-04-22, 1399/02/03
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Expected recruitment end date
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2020-06-23, 1399/04/03
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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 effects of the 2-drug diet (hydroxychloroquine + umifenovir(Arbidol)) compared with Hydroxy chlorquine on the of mortality rate in patients with moderate symptoms of COVID-19 infections: A randomized interventional study in Imam Reza Hospital, Mashhad.
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Public title
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effects of the 2-drug diet (hydroxychloroquine + umifenovir(Arbidol)) compared with Hydroxy chlorquine on the of mortality rate in patients with moderate symptoms of COVID-19 infections
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Informed consent for inclusion in the study
Age range within 18 to 65
Intial symptoms during the first 12 days
Diagnosis with COVID-19 is definitive
Moderate symptoms of COVID-19 and need for hospitalization, SPO2<93%, pulmonary infiltration in chest radiography or CT scan and clinical judgment of a specialist
Exclusion criteria:
Pregnancy
Having morbidities such as heart diseases which do not allow the use of treatment drugs
History of retinopathy which does not allow the use of Hydroxy chlorquine.
Patient with severe condition who will not last more than 48 hours
Infection with HIV
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Age
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From 18 years old to 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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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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Simple randomization will be carried out using table of random numbers available at 'www.randomization.com' website where the produced numbers are placed in sealed envelopes assigning each patient to one of the two groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The data analyst is unaware of the groups each patient belongs to.
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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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2020-06-06, 1399/03/17
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Ethics committee reference number
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IR.MUMS.REC.1399.288
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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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified site
Primary outcomes
1
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Description
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Fever
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Timepoint
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Before and after treatment
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Method of measurement
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Thermometer
2
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Description
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Respiration rate
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Timepoint
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Before and after treatment
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Method of measurement
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Counting the number of breaths patients take per minute
3
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Description
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Findings of chest CT scan
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Timepoint
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Before and after treatment
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Method of measurement
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CT scan machine
4
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Description
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Pulse
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Timepoint
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Before, during and after treatment
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Method of measurement
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Patient monitoring device
5
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Description
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SpO2
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Timepoint
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Before and after treatment
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Method of measurement
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Patient monitoring device
6
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Description
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WBC
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Timepoint
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Before and after treatment
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Method of measurement
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Biochemical test
7
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Description
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Number of lymphocytes
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Timepoint
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Before and after treatment
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Method of measurement
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Biochemical test
8
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Description
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Lactate dehydrogenase
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Timepoint
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Before and after treatment
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Method of measurement
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Biochemical test
9
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Description
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C reactive protein (CRP)
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Timepoint
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Before and after treatment
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Method of measurement
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Biochemical test
Intervention groups
1
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Description
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Intervention group: In this group, patients with moderate symptoms of COVID-19 take the two-drug diet of 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days in addition to 100 mg Arbidol (Made in Russia (received from the Ministry)) every 8 hours 2 tablets for at least 7 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 in this group routinely receive 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 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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Mashhad 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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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 are made unidentifiable.
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When the data will become available and for how long
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Data can be accessible 6 months after results are published.
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To whom data/document is available
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Data will be available for researchers in universities and other scientific institutes.
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Under which criteria data/document could be used
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Carrying out analysis on data is permitted.
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From where data/document is obtainable
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Data can be accessible through an email to the corresponding author.
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What processes are involved for a request to access data/document
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After sending a request email to the corresponding author, data will be sent in 1 month.
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Comments
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