Protocol summary
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Study aim
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Investigating the efficacy and safety of N-acetyl-cysteine (NAC) inhalation spray in controlling the symptoms of patients with COVID-19
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Design
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This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
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Settings and conduct
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Patients who is admitted to Baqiyatallah hospital, and is 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 either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or 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 receive medical care from the intensive care unit;
Pregnancy;
Lactation
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Intervention groups
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Intervention group: NAC nasal spray (200 microgram/puff) 1 puff 12 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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The study is complete.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080901001165N55
Registration date:
2020-05-23, 1399/03/03
Registration timing:
registered_while_recruiting
Last update:
2022-04-15, 1401/01/26
Update count:
1
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Registration date
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2020-05-23, 1399/03/03
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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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2020-05-13, 1399/02/24
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Expected recruitment end date
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2020-08-14, 1399/05/24
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Actual recruitment start date
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2020-05-14, 1399/02/25
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Actual recruitment end date
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2020-08-15, 1399/05/25
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Trial completion date
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2020-08-31, 1399/06/10
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Scientific title
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Investigating the efficacy and safety of N-Acetyl Cysteine (NAC) inhalation 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 N-Acetyl Cysteine (NAC) inhalation 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 either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this nasal spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
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:
250
Actual sample size reached:
250
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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 method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each 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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2020-05-02, 1399/02/13
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Ethics committee reference number
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IR.BMSU.REC.1399.123
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
Secondary outcomes
1
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Description
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Lab. tests changes
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Timepoint
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Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
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Method of measurement
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Blood sample, laboratory analysis
2
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Description
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Side effects
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Timepoint
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Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
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Method of measurement
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Physical examination
Intervention groups
1
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Description
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Intervention group: NAC inhalation spray (200 microgram NAC/puff) 1 puff every 12 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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Bagheiat-allah University of Medical Sciences
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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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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
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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No
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Title of funding source
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Baqiyatallah University of Medical Science
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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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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
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