Increase the chances of recovery, reduce death, and reduce the need for intensive care and mechanical ventilation by adding injectable selenium to the treatment regimen of patients with 19-year-old inpatients.
Design
At Sabzevar Vasei Hospital Medical Center, patients with 19-year-old patients with a diagnosis based on pulmonary CT scan or PCR are being examined.
If the patient would have indication to be hospitalized for more than 24 hours, after obtaining informed consent from the patient, they are randomly assigned to the control and intervention group.
Based on the latest Corona Protocol, the routine treatment control group includes antiretroviral therapy and, if indicated, antibiotic therapy. Receipts are given. The first day and then 500 micrograms every 12 days from the second day onwards.
Settings and conduct
At Sabzevar Vasei Hospital Medical Center, patients with 19-year-old patients with a diagnosis based on pulmonary CT scan or PCR are being examined.
Participants/Inclusion and exclusion criteria
Patients with COVID-19 who have been diagnosed based on lung imaging evidence or PCR of results of the pharyngeal mucosa will be enrolled. Patients will be excluded from the study if they are under mechanical ventilation when entering the study.
Intervention groups
In the intervention group until discharge, in addition to antiviral treatments according to the national protocol, the injected selenium will be prescribed 1000 micrograms every 12 hours on the first day and then 500 micrograms every 12 days from the second day.
Main outcome variables
The need for hospitalization in the intensive care unit, the need for mechanical ventilation, the number of hospital days and the outcome of treatment (death / discharge)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160706028815N5
Registration date:2020-05-05, 1399/02/16
Registration timing:prospective
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Seyed Alireza Javadinia
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
javadiniaa941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of addition of selenium to treatment regimen of hospitalized patients with COVID-19 on the outcome of disease compared with control group
Public title
The effect of addition of selenium to treatment regimen of hospitalized patients with corona on the outcome of disease compared with control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patient
Presence of COVID-19 infection in the lung imaging
COVID-19 PCR positive patients
Age more than 18 years old
Exclusion criteria:
Mechanical ventilation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using a simple random method (table of random numbers). To produce table of random numbers, we will use https://www.random.org with a range of numbers 1-40 (equal to sample size). Then after, patients will enroll to the study based on their referral/visit considering the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Sabzevar University of Medical Sciences
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MEDSAB.REC.1399.017
Health conditions studied
1
Description of health condition studied
COVID-19 treatment
ICD-10 code
B97.29
ICD-10 code description
Coronavirus disease (covid-19)
Primary outcomes
1
Description
Need mechanical ventilation
Timepoint
during hospitalization
Method of measurement
daily visit
2
Description
Need to be hospitalized in the intensive care unit
Timepoint
during hospitalization
Method of measurement
daily visit
3
Description
Duration of hospitalization
Timepoint
during hospitalization
Method of measurement
daily visit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group until discharge, in addition to antiviral treatments according to the national protocol, injectable selenium will be prescribed in the form of 1000 micrograms every 12 hours on the first day and then 500 micrograms every 12 days from the second day onwards.
Category
Treatment - Drugs
2
Description
Control group: the control group until discharge will receive antiviral treatments according to the national protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Educational and Medical Center
Full name of responsible person
Afsaneh Kaffash
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
vasei.h@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
GhoratF@medsab.ac.ir
Grant name
The effect of addition of selenium to treatment regimen of hospitalized patients with COVID-19 on the outcome of disease compared with control group
Grant code / Reference number
99008
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Afsaneh Kaffash
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
DrKaffash@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Afsaneh Kaffash
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
DrKaffash@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Afsaneh Kaffash
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
DrKaffash@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Clinical information (including therapeutic outcomes), laboratory and demographic of Coronavirus patients 2019 under treatment with routine and selenium
When the data will become available and for how long
About 5 to 10 months after the start of the study
To whom data/document is available
Public
Under which criteria data/document could be used
Careful study information can be provided to qualified researchers interested in treating patients.
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can receive data documentation from the responsible author after presenting the work by presenting their academic information and identification.