Protocol summary

Study aim
Investigating the efficacy and safety of N-acetyl-cysteine (NAC) inhalation spray in controlling the symptoms of patients with COVID-19
Design
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Clinical symptoms changes (dry cough, respiratory distress, fever)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001165N55
Registration date: 2020-05-23, 1399/03/03
Registration timing: registered_while_recruiting

Last update: 2020-05-23, 1399/03/03
Update count: 0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-13, 1399/02/24
Expected recruitment end date
2020-08-14, 1399/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy and safety of N-Acetyl Cysteine (NAC) inhalation spray in controlling the symptoms of patients with COVID-19
Public title
Investigating the efficacy and safety of N-Acetyl Cysteine (NAC) inhalation spray in controlling the symptoms of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.BMSU.REC.1399.123

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Clinical symptoms (dry cough)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Physical examination,questionnaire

2

Description
Clinical symptoms (respiratory distress)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Pulse-oxymetery device

3

Description
Clinical symptoms (fever)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Thermometer

Secondary outcomes

1

Description
Lab. tests changes
Timepoint
Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
Method of measurement
Blood sample, laboratory analysis

2

Description
Side effects
Timepoint
Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
Method of measurement
Physical examination

Intervention groups

1

Description
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)
Category
Treatment - Drugs

2

Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Mostafa Ghanei
Street address
Baqiyatallah hospital, Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
mghaneister@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Sina Darou Laboratories Company
Full name of responsible person
Dr. Rezaeiyan
Street address
Sina Darou Laboratories Company, Shahid Gomnam St., 52th Boulevard, 15th km of Karaj special road
City
Tehran
Province
Tehran
Postal code
1388167311
Phone
+98 21 4419 4521
Email
info@sinadarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiyatallah University of Medical Science
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Pharmacy faculty, Tehran University of Medical Science, 16-Azar St., Enghelab Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
parisa_kianpour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Critical Care Pharmacotherapy
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
Yunespanahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Pharmacy faculty, Tehran University of Medical Science, 16-Azar St., Enghelab Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
parisa_kianpour@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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