Protocol summary
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Study aim
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Evaluation of the effect of Quercetin on the effectiveness of antiviral drug regimen in patients with COVID19
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Design
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This study is a two arm parallel groups clinical trial that will be done in Ahvaz hospital. Randomization is done through block method. Sample size of this study is 60 patients that divided equally into two groups include intervention and control group . Intervention and control groups treat with the same method, except the intervention group that receive 2 Tabs Quercetin from Jarrow Formulas. This a phase 3 clinical trial. In both groups clinical outcome and side effects are evaluated.
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Settings and conduct
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A randomized clinical trial that will be done in َAhvaz hospital. According to inclusion and exclusion criteria, patients are randomly divided into 2 groups. Both groups receive the same treatment. Intervention group will receive 2 Tabs Quercetin from Jarrow Formulas daily until 7 days. Blinding is not done in our study.
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Participants/Inclusion and exclusion criteria
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Polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging Hospitalized withOr Cough
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study
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Intervention groups
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Intervention group: 2 Tabs Quercetin from Jarrow Formulas, daily until 7days. Both case and control group will be received routine drugs.
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Main outcome variables
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Time to clinical recovery, respiratory signs, Intubation rate.
General information
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Reason for update
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In order to more accurately record clinical trial information, some changes in the study Design, Inclusion and exclusion criteria have been updated. The ICD-10 code description was revised
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200419047128N2
Registration date:
2020-04-24, 1399/02/05
Registration timing:
prospective
Last update:
2021-07-04, 1400/04/13
Update count:
1
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Registration date
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2020-04-24, 1399/02/05
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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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2020-05-09, 1399/02/20
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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 quercetin on the effectiveness of antiviral drug regimen in patients with COVID19
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Public title
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Quercetin in COVID19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging Hospitalized with: Fever (axillar or oral temperature ≥ 38.0 °centigrade(C) or ≥38.6°centigrade tympanic or rectal) Or Cough
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study
Exclusion criteria:
Autoimmune diseases (lupus, MS, etc.)
Hepatic failure Hepatit B, C,
pregnant and lactating women Not consent to participate in the study
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Age
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No age limit
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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:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit , making a random sequence is by using statistical software(WinPepi11.0). Allocation concealment is by assigning unique codes
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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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2020-04-18, 1399/01/30
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Ethics committee reference number
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IR.AJUMS.REC.1399.087
Health conditions studied
1
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Description of health condition studied
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COVID19
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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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Corona virus infection, unspecified
Primary outcomes
1
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Description
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Viral diagnostic test
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Timepoint
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The first day of the study and the end of the study (14th)
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Method of measurement
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Polymerase chain reaction
Secondary outcomes
1
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Description
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Blood oxygen saturation percentage
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Timepoint
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Before and-4-7 days after starting treatment
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Method of measurement
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Pulse oximeter
2
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Description
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Cough rate
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Timepoint
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Before and 7 days after starting treatment
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Method of measurement
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Physical examination
3
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Description
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C-Reactive Protein (CRP)
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Timepoint
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Before and 7 days after starting treatment
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Method of measurement
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ٍELISA (enzyme-linked immunosorbent assay)
4
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Description
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IL1
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Timepoint
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Before and 7 days after starting treatment
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Method of measurement
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ELISA (enzyme-linked immunosorbent assay)
5
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Description
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IL6
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Timepoint
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Before and 7 days after starting treatment
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Method of measurement
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ELISA (enzyme-linked immunosorbent assay)
6
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Description
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CBC
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Timepoint
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Before and 7 days after starting treatment
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Method of measurement
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Cell Counter
Intervention groups
1
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Description
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Intervention group: 2 Tabs Quercetin(500mg) from Jarrow Formulas , daily until 7 days. Both case and control group will be received routine drugs.
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Category
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Treatment - Drugs
2
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Description
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Control group: this group doesnt receive extra drugs. Both groups receive routine drugs.
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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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Ahvaz 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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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