Evaluation of the effectiveness of selenium added to intravenous nutrition therapy on mortality and duration of ICU hospitalization in patients with COVID-19 disease
Evaluation of the effectiveness of selenium in mortality and duration of ICU hospitalization in patients with mechanical ventilation with COVID-19 at Nekouei Hospital
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 80 patients. For randomization four cards that are in the bag will be used.
Settings and conduct
ICU Department of nekooie hedayati Forghani Hospital, Qom University of Medical Sciences, Patients were divided into control and case groups, and at the end of the study
The prescribing physician does not know if group one is treatment or group two
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients diagnosed with Covid-19 disease by infectious disease physician; Patients who are hospitalized in the intensive care unit and three days have passed since their hospitalization; Patients who are intubated and connected to the ventilator.
Non-inclusion: Patients with COVID 19 but not Intubation
Intervention groups
Intervention group: Selenium 1 mg at the beginning and 500 micrograms daily will be prescribed during 15 minutes at 2 PM every day for 5 days.
Control group: In the control group, only routine drugs are given.
Main outcome variables
Duration of hospitalization; mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160919029870N3
Registration date:2020-11-24, 1399/09/04
Registration timing:retrospective
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Reza Heydarifar
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 748 3621
Email address
rheidarifar@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2020-06-20, 1399/03/31
Trial completion date
2020-06-20, 1399/03/31
Scientific title
Evaluation of the effectiveness of selenium added to intravenous nutrition therapy on mortality and duration of ICU hospitalization in patients with COVID-19 disease
Public title
The effect of selenium in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with Covid-19 disease by infectious disease physician
Patients who are hospitalized in the special ward and three days have been passed since their hospitalization
Patients who are intubated and connected to a ventilator
Exclusion criteria:
Patients with covid-19 who are not intubated.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using block randomization with blocks of size 4. All four modes: AABB, ABAB, BBAA, BABA are written on four cards, and four patients are randomly allocated to groups, respectively. The ward's head takes the card out of the bag, and the patients are divided into groups by chance. For example, if the card is AABB, the first and second patients are in the first group, and the third and fourth patients are in the second group, and also for the next four patients, another card will be drawn.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since patients have no knowledge of the drug, they were blinded in this study. The researcher is unaware of the grouping of drugs, and after statistical analysis, it is determined that group A was the treatment group and group B was the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.MUQ.REC.1398.161
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 hospitalization
Timepoint
The first day of patients' arrival and the day of discharge from the ICU or death of patients
Method of measurement
Number of days patients are admitted to the ICU
Secondary outcomes
1
Description
Death
Timepoint
Daily from the day of admission to the special ward until discharge or death of patients
Method of measurement
Document
Intervention groups
1
Description
Intervention group: according to the protocol, in this group, one mg of selenium in the form of stat (initial dose and amount) and 500 micrograms of intravenous infusion for 15 minutes at 2 pm every day are administrated by an anesthesiologist for five days.
Category
Treatment - Drugs
2
Description
Control group: Routine procedures are performed on a patient with confirmed COVID-19.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nekouei Hedayati Forqani Hospital, Qom
Full name of responsible person
Hamed Shafiee
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Phone
+98 25 3133 1602
Email
rheidarifar@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hamed Shafiee
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Phone
+98 25 3133 1602
Email
rheidarifar@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Hamed Shafiee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Phone
+98 25 3133 1602
Email
rheidarifar@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hamed Shafiee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Phone
+98 25 3133 1602
Email
rheidarifar@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hamed Shafiee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Unit; Nekouei hospital; Shahid Delazar street
City
Qom
Province
Ghoum
Postal code
3714935455
Phone
+98 25 3133 1602
Email
rheidarifar@muq.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
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
Yes - There is 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
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
What processes are involved for a request to access data/document