Protocol summary
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Study aim
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Investigating the efficacy and safety of Nivasha oral spray in controlling the symptoms of patients with COVID-19
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Design
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This study is a multi-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
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Settings and conduct
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Outpatients referred to Baqiyatallah Hospital at Tehran and Shahid.motahari Hospital at Isfahan who meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms
Exclusion criteria: history of allergy to ingredients; The patient is in another clinical trial at the same time; The patient needs to be hospitalized.
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Intervention groups
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Intervention group: Nivasha oral spray 1 puff into the mouth every 6 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus).
Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus.
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Main outcome variables
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Clinical symptoms changes (dry cough, respiratory distress, fever)
General information
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Reason for update
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Applying the latest executive changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080901001165N59
Registration date:
2020-05-27, 1399/03/07
Registration timing:
prospective
Last update:
2020-12-12, 1399/09/22
Update count:
2
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Registration date
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2020-05-27, 1399/03/07
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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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2020-05-25, 1399/03/05
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Expected recruitment end date
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2020-07-26, 1399/05/05
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Actual recruitment start date
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2020-06-21, 1399/04/01
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Actual recruitment end date
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2020-09-21, 1399/06/31
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Trial completion date
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2020-09-27, 1399/07/06
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Scientific title
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Investigating the efficacy and safety of Nivasha oral spray in controlling the symptoms of patients with COVID-19
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Public title
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Investigating the efficacy and safety of Nivasha oral spray in controlling the symptoms of patients with 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: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to be hospitalized;
Pregnancy;
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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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
138
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block Randomization (4*4 blocks) with random table number method is used to randomized the patients. Even numbers were considered for the intervention group and odd numbers for the control group.
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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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2020-05-23, 1399/03/03
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Ethics committee reference number
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ir.bmsu.rec.1399.021
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 symptoms (dry cough)
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Timepoint
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Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
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Method of measurement
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Physical examination,questionnaire
2
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Description
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Clinical symptoms (respiratory distress)
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Timepoint
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Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
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Method of measurement
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Pulse-oxymetery device
3
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Description
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Clinical symptoms (fever)
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Timepoint
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Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
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Method of measurement
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Thermometer
Intervention groups
1
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Description
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Intervention group: Nivasha spray 1 puff into the mouth every 6 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
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Category
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Treatment - Drugs
2
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Description
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Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus
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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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Nanoalvand arad company
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Proportion provided by this source
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80
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Public or private sector
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Private
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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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Industry
2
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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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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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20
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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