Protocol summary
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Study aim
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Evaluation of efficacy and safety of umifenovir in the treatment of the patients with covid-19
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Design
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Phase 3,2 arms each arms 50 patients, block randomization
Two arm parallel group double blind randomised trial , one group as a placebo control group and another one intervention group, physicians and patients are blind
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Settings and conduct
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Sina hospital, randomize double blind(physicians and patients are blind)
Patients are divided in two groups by Block Randomization method, one group as a placebo control group and another one as an intervention group
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
-age>18
-Patients with probable and definitive diagnosis of covid-19
-Presence of at least one clinical sign(fever,chill,myalgia,cough) with positive virologic specimen response or imaging findings for covid-19
Exclusion criteria:
-Patients or companion dissatisfaction to enter or continue the study
-History or symtoms for hypersensivity to drug
-Pregnancy/lactation
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Intervention groups
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Intervention group: Hydroxychlorquine 400 mg every 12 hours in the first day then 200 mg every 12 hours ,Atazanavir/Ritonavir 300/100 mg once daily, Uumifenovir 100 mg 2 capsules every 6 hours.
Control group: Hydroxychloroquine 400 mg every 12 hours for the first day then 200 mg every 12 hours Atazanavir / ritonavir 300/100 mg, two placebo capsules (hand made) every 6 hours.
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Main outcome variables
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Clinical improvment includes Fever rupture,Spo2 >93 ,Improvment of respiratory symptoms.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200322046833N1
Registration date:
2020-04-03, 1399/01/15
Registration timing:
registered_while_recruiting
Last update:
2020-04-14, 1399/01/26
Update count:
1
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Registration date
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2020-04-03, 1399/01/15
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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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2020-03-28, 1399/01/09
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Expected recruitment end date
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2020-04-20, 1399/02/01
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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 efficacy and safety of Umifenovir in the treatment of hospitalized patients with covid-19: A randomized clinical trial
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Public title
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Umifenovir effectiveness in the 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 >18 years old
Patients with a probable and definitive diagnosis of COVID-19 who are candidates for hospitalization and receiving antiviral regimens.
Presence of at least one clinical sign (including fever, chills, cough, myalgia) with positive virologic specimen or imaging findings for COVID-19
Exclusion criteria:
Patient or fellows' dissatisfaction with entering or continuing the study
History or any signs of hypersensitivity to umifenovir
Pregnancy and lactation
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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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- Participant
- Care provider
- Investigator
- Outcome assessor
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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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In this study, we will use block randomization methods using four patents blocks that randomized by ( RAND) function in Excel .The patient code table is provided to the analyzer and will be used for analysis after completion of the study.
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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: The patient, the physician, the nurses, and the researchers are blind. The data analyst knows the details of the treatment regimen.
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Placebo
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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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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1037
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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Covid-19
Primary outcomes
1
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Description
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Clinical improvement includes fever rupture
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Timepoint
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Since admission to the hospital then daily monitoring
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Method of measurement
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Physical examination, thermometer, questionnaire
2
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Description
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Clinical improvement includes SPO2 >93%
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Timepoint
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Since admission to the hospital then daily monitoring
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Method of measurement
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Physical examination, pulse oxymetery,questionnaire
3
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Description
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Improvement of respiratory symptoms
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Timepoint
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Since admission to the hospital then daily monitoring
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Method of measurement
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Physical examination, ct scan,questionnaire
4
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Description
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Adverse effects
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Timepoint
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Since admission to the hospital then daily monitoring
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Method of measurement
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Questionnaire, physical examination
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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7 days to 1 months after beginning the treatment
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Method of measurement
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Questionnaire
2
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Description
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Clinical outcome
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Timepoint
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7 days to 1 months after beginning the treatment
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Method of measurement
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Questionnaire
3
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Description
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Lipoxin
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Timepoint
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day-0, day-2, day-4
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Method of measurement
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measuring the plasma concentration of the biomarker with ELISA kit
4
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Description
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prostaglandin
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Timepoint
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day-0, day-2, day-4
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Method of measurement
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measuring the plasma concentration of the biomarker with ELISA kit
5
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Description
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leukotriene
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Timepoint
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day-0, day-2, day-4
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Method of measurement
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measuring the plasma concentration of the biomarker with ELISA kit
6
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Description
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resolvin
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Timepoint
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day-0, day-2, day-4
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Method of measurement
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measuring the plasma concentration of the biomarker with ELISA kit
Intervention groups
1
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Description
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Intervention group: Hydroxychloroquine 400 mg every 12 hours for the first day then 200 mg every 12 hours Atazanavir / ritonavir 300/100 mg once daily. Arbidol 100 mg(manufactured by Pharmstandard)2 capsules every 6 hours.
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Category
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Treatment - Drugs
2
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Description
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Control group: Hydroxychloroquine 400 mg every 12 hours for the first day then 200 mg every 12 hours Atazanavir / ritonavir 300/100 mg, two placebo capsules (hand made) every 6 hours.
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Category
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Placebo
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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Center for Progress and Development of Iran
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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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Other
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