Comparison of the effect of vitamin C and N-acetyl cysteine (NAC) on improving clinical symptoms and reducing the duration of hospitalization in patients with covid-19
Comparison of the effect of vitamin C and N-acetyl cysteine (NAC) on improving clinical symptoms and reducing the duration of hospitalization in patients with covid-19
Design
The study will be double blind and clinical trial. 232 patients will be randomly divided into 2 groups. The groups will be parallel. The trial phase will be 3
Settings and conduct
Patients with covid-19 in Arak are divided into 2 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, no pregnancy or lactation, no deficiency of G6PD enzyme, no history of calcium oxalate kidney stones, no sensitivity to drugs
Exclusion criteria: dissatisfaction
Intervention groups
Intervention group 1: Vitamin C tablets with a dose of 1 gram are given every 8 hours for 5 days.
Intervention group 2: N-acetylcysteine tablets at a dose of 600 mg every 8 hours for 5 days.
Main outcome variables
Duration of hospitalization in the intensive care unit, percentage of oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N160
Registration date:2021-06-06, 1400/03/16
Registration timing:prospective
Last update:2021-06-06, 1400/03/16
Update count:0
Registration date
2021-06-06, 1400/03/16
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin C and N-acetyl cysteine (NAC) on improving clinical symptoms and reducing the duration of hospitalization in patients with covid-19
Public title
Comparison of the effect of vitamin C and N-acetyl cysteine (NAC) on improving clinical symptoms and reducing the duration of hospitalization in patients with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
No pregnancy or breastfeeding
Absence of G6PD deficiency
No history of calcium oxalate kidney stones
Lack of sensitivity to drugs
Exclusion criteria:
Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
232
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B . In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. In this study, patients consciously consented to take vitamin C and N-acetylcysteine supplements but did not know the type of group they were entering. The drug is prescribed by infectious and internal medicine physicians in charge of the project and is randomly given to one of these two groups; However, the intern in charge of the project, who is responsible for registering questionnaires and collecting data, also does not know about the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.ARAKMU.REC.1400.021
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
Percentage of oxygen saturation
Timepoint
During the intervention
Method of measurement
Pulse oximetry
2
Description
Duration of hospitalization in the intensive care unit
Timepoint
During the intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Vitamin C tablets with a dose of 1 gram are given every 8 hours for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: N-acetylcysteine tablets at a dose of 600 mg every 8 hours for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Amiralmomenin hospital, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3603
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street