Evaluation of the effect of N-acetyl cysteine on the prognosis of hospitalized children with covid 19 : a pilot-randomized-double blinded-placebo-controlled clinical trial
according to the limitation of using drugs in children with covid-19 and in the other hand safety of NAC and the good effects of this drug in adults ,if we get positive result we can use this drug in a large number of children.
Design
this clinical trial has a control group with parallel groups , double blinded , randomized , on 40 patients , we will use https://www.sealedenvelope.com for randomization.
Settings and conduct
the trial will performed at 17 shahrivar hospital in rasht , the trial will performed at two groups of intervention and control , participants , doctors and nurses will be blind and they will not know the wich patient takes NAC which one takes placebo.
Participants/Inclusion and exclusion criteria
entry requirements : every child with 8 to 18 ages of year with clinical diagnosis of covid including positive PCR test and chest radiography coming to 17 sahrivar hospital in rasht.
no entry condition : parents or patients dissatisfaction for participating in study ,patients with severe covid or patients who hospitalized in ICU
Intervention groups
the first group receives 600mg of NAC (effervescent tablets of osweh company) twice a day and second group receives placebo effervescent tablets(osweh company) twice a day by enteral method , the duration of receiving the intervention is 7 days.
Main outcome variables
duration of need to ventilator and improvement of clinical symptoms and inflammatory factors (CRP) , hospitalized in intensive care unit and patients condition at discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054879N1
Registration date:2022-06-11, 1401/03/21
Registration timing:registered_while_recruiting
Last update:2022-06-11, 1401/03/21
Update count:0
Registration date
2022-06-11, 1401/03/21
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of N-acetyl cysteine on the prognosis of hospitalized children with covid 19 : a pilot-randomized-double blinded-placebo-controlled clinical trial
Public title
Evaluation of the effect of N-acetyl cysteine on the prognosis of hospitalized children with covid 19 : a pilot-randomized-double blinded-placebo-controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
every child with 8 to 18 ages of year with clinical diagnosis of covid including positive PCR test and chest radiography coming to 17 sahrivar hospital in rasht.
Exclusion criteria:
parents or patients dissatisfaction for participating in study
patients with severe covid or patients who hospitalized in ICU
Age
From 8 years old to 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
in this study the patients will randomized with blocking randomization , with ratio of 1:1 . after that they will divided to 2 groups. 30 people of children with age of under 18 with covid will divided to 2 groups which are intervention and control , A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
the groups of patients will determine after randomization , participants and doctors who are responsible for health of children are blind on this study , also radiologists , evaluating researchers and statistics specialist will be blind in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Deputy of research and Technology, In front of 17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.GUMS.REC.1401.018
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
duration of need to ventilator
Timepoint
desired factor will measure at first of hospitalization then after 7 days or at the time of discharge.
Method of measurement
the prognosis of patients with time of hospitalization and the period of time need to ventilator and status at the time of discharge will evaluate.
2
Description
improvement of clinical signs and oxygenation
Timepoint
desired factor will measure at first of hospitalization then after 7 days or at the time of discharge.
Method of measurement
the prognosis of patients with time of hospitalization and the period of time need to ventilator and status at the time of discharge will evaluate.
3
Description
CRP inflammatory factor
Timepoint
desired factor will measure at first of hospitalization then after 7 days or at the time of discharge.
Method of measurement
the prognosis of patients with time of hospitalization and the period of time need to ventilator and status at the time of discharge will evaluate.
4
Description
Hospitalization in the intensive care unit
Timepoint
will be checked if transfer occur
Method of measurement
the prognosis of patients with time of hospitalization and the period of time need to ventilator and status at the time of discharge will evaluate.
5
Description
patient status at discharge
Timepoint
at the discharge
Method of measurement
the prognosis of patients with time of hospitalization and the period of time need to ventilator and status at the time of discharge will evaluate.
Secondary outcomes
1
Description
secondary variable is patient status at the time of discharge(recovery)
Timepoint
at the discharge
Method of measurement
order and diagnosis of pediatrician
2
Description
secondary variable is patient status at the time of discharge (transfer to the intensive care unit or death)
Timepoint
at the discharge or transfer
Method of measurement
order and diagnosis of pediatrician
Intervention groups
1
Description
Intervention group: in this trial we will use effervescent tablets of NAC from osveh company with dose of 600 mg BD , duration of prescription is 7 days or until discharge.
Category
Treatment - Drugs
2
Description
Control group: in this group we will use effervescent placebo of NAC (osveh company) BD (twice in a day) for 7 days or until discharge.
Unit 2, Kian Apartment, 175 Street, Guilan Boulvar, Golsar, Rasht
City
Rasht
Province
Guilan
Postal code
4166743374
Phone
+98 13 3377 4513
Email
pouria_seifnezhad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
attention to patients privacy and also ethical principles.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
results of this clinical trial will be available , private information will be available just for treatment staff , for the privacy of patients , the patients information will reserved near researcher.
When the data will become available and for how long
there is no program to publication till now , but if we want to publish it will be 6 months after result.
To whom data/document is available
researchers working on this field , pediatricians and educated doctors for reaching our datas.
Under which criteria data/document could be used
doctors and researchers can receive the data , limitation is patient privacy and medical ethics.
From where data/document is obtainable
Dr maryam shahrokhi - 17 shahrivar hospital -Rasht
pharmacy faculty , guilan university of medical sciences , pouria seifnezhad
What processes are involved for a request to access data/document
coming to 17 shahrivar hospital in rasht and signing the form then visiting the mail researcher of the trial and investigate the request - then consultation with medical ethics committee and after that giving the data