This study aims to investigate the effect of N-Acetylcysteine on the recovery process of severe COVID-19 patients.
Design
Concealed, randomized, single blinded, phase 3 controlled clinical trial with two arm parallel group design of 40 patients, using the placebo in the control group.
Settings and conduct
This study will be performed in Shahid Mohammadi Hospital in Bandar Abbas city. Patients enter the study after obtaining written consent. Patients are randomly assigned to one of the intervention or control groups with the placebo. Also, patients will not know which group they belong to. (single blinded)
Participants/Inclusion and exclusion criteria
All COVID-19 patients admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas, whose PCR test results are positive for SARS-Cov-2 and signs the written consent of the study will be included in the study. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study.
Intervention groups
Patients are divided into two groups. In group A, the standard treatment for COVID-19 patients with N-Acetylcysteine is prescribed. In group B, patients receive standard COVID-19 treatment with the placebo.
Main outcome variables
Patient's clinical symptoms and laboratory examinations.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047364N3
Registration date:2021-02-20, 1399/12/02
Registration timing:prospective
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Dariush Hooshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3670 3778
Email address
dariush.hooshyar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-02, 1399/12/12
Expected recruitment end date
2021-04-01, 1400/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial
Public title
The effect of N-Acetylcysteine on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All COVID-19 patients whose disease has been confirmed by the PCR test for SARS-Cov-2.
Having one of the criteria for severe COVID-19 disease includes tachypnea (respiration rate> 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), LDH> 245 U / l, Progressive lymphopenia.
Hospitalized in the intensive care unit.
Signing the written consent of the study participant.
Exclusion criteria:
Known allergy or hypersensitivity to N-Acetylcysteine.
Pregnancy
The participant refused to participate in the continuation of the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals.
the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method.
Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification.
eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions.
(randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all participants are aware of participating in this study and enter the study with their consent. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive N-Acetylcysteine in the treatment group and receive a placebo in the control group.
The lead researcher, health care personnel, data collection officials, and those who evaluate the outcome are aware of the grouping of patients.
Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.HUMS.REC.1399.539
Health conditions studied
1
Description of health condition studied
Laboratory confirmed COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Patient's clinical condition
Timepoint
At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge
Method of measurement
Clinical examinations
2
Description
Length of Intensive Care Unit admission
Timepoint
At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge
Method of measurement
Record patient information
Secondary outcomes
1
Description
Respiratory rate
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pulse oximeter
2
Description
Oxygen saturation state
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pulse oximeter
3
Description
Lung infiltration status
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Chest X-ray
4
Description
Lactate Dehydrogenase(LDH) level's
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pathobiology laboratory
5
Description
C-reactive protein(CRP) level's
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pathobiology laboratory
6
Description
Lymphocyte count
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pathobiology laboratory
7
Description
Platelet count
Timepoint
At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge.
Method of measurement
Pathobiology laboratory
Intervention groups
1
Description
Intervention group: Group A receives standard drug therapy based on the treatment protocols of the National Committee COVID-19 and N-Acetylcysteine (Exi-Nac 2g/10ml AMP (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 g as a slow single intravenous injection on the first day of hospitalization. Vital signs of patients are also checked at regular intervals and frequently. Standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days.
Category
Treatment - Drugs
2
Description
Control group: Group B receives standard drug therapy based on the treatment protocols of the National COVID-19 Committee and placebo as a slow single intravenous injection on the first day of hospitalization. Standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr. Arash Rahimi
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teamur Aghamolaei
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
https://resv.hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dariush Hooshyar
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 990 038 7226
Email
dariush.hooshyar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@gmail.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