Evaluating the effect of intravenous N-acetyl cysteine versus placebo in the treatment of patients with mild and moderate acute respiratory distress syndrome caused by COVID-19: A double-blind randomized clinical trial
To assess the effect of intravenous N-acetyl cysteine versus placebo in the treatment of patients with mild and moderate acute respiratory distress syndrome caused by COVID-19
Design
This is a double-blind randomized clinical trial, phase II, in which 92 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with mild and moderate acute respiratory distress syndrome caused by COVID-19 referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years,
Being hospitalized in the intensive care unit in less than the past 48 hours,
Mild to moderate acute respiratory distress syndrome due to COVID-19,
Bilateral pulmonary infiltration in chest X-ray or CT-scan,
Respiratory distress with more than 24 breathe per minute
Exclusion criteria:
Pregnancy or breastfeeding,
Cardiopulmonary edema,
Severe acute respiratory distress syndrome,
Using antioxidant drugs,
Chronic liver or renal disease,
Contraindication of N-acetyl cysteine
Intervention groups
Intervention group:
Routine care plus intravenous infusion of N-acetyl cysteine 40 mg/kg/day diluted in 100 ml dextrose 5% for 3 days
Control group:
Routine care plus intravenous infusion of 100 ml dextrose 5% daily for 3 days
Main outcome variables
Primary outcome:
Need for mechanical ventilation, the patient's clinical status, the mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N355
Registration date:2020-05-18, 1399/02/29
Registration timing:prospective
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of intravenous N-acetyl cysteine versus placebo in the treatment of patients with mild and moderate acute respiratory distress syndrome caused by COVID-19: A double-blind randomized clinical trial
Public title
Evaluating the effect of intravenous N-acetyl cysteine versus placebo in the treatment of patients with mild and moderate acute respiratory distress syndrome caused by COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years,
Being hospitalized in intensive care unit in less than past 48 hours,
Mild to moderate acute respiratory distress syndrome due to COVID-19,
Bilateral pulmonary infiltration in chest X-ray or CT-scan,
Respiratory distress with more than 24 breathe per minute
Exclusion criteria:
Pregnancy or breastfeeding,
Cardiopulmonary edema,
Severe acute respiratory distress syndrome,
Using antioxidant drugs,
Chronic liver or renal disease,
Contraindication of N-acetyl cysteine
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.UMSHA.REC.1399.153
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Need to mechanical ventilation
Timepoint
Within 28 days after the intervention
Method of measurement
By physical examination
2
Description
The patient's clinical status
Timepoint
Within 28 days after the intervention
Method of measurement
Based on the World Health Organization's 7-score system
3
Description
Mortality rate
Timepoint
Within 28 days after the intervention
Method of measurement
Based on medical document
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus intravenous infusion of N-acetyl cysteine 40 mg/kg/day diluted in 100 ml dextrose 5% for 3 days
Category
Treatment - Drugs
2
Description
Control group: Routine care plus intravenous infusion of 100 ml dextrose 5% daily for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Abbas Taher
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
t_anesthesia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Abbas Taher
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
t_anesthesia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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