In this study, we will examine the effect of Selenium administration on the physical burden associated with ARDS, mortality, and the need for hospitalization in patients diagnosed with COVID-19 at early stages
Design
A double-blinded randomized controlled trial
Settings and conduct
100 patients who meet the eligibility criteria will be selected to participate in this study. Participants will be randomized into two groups using a simple permuted block randomization technique. Participants in the control group will receive the hospital's standard protocol for the treatment of COVID-19. The intervention group will receive 200 micrograms of selenium daily in addition to the standard treatment protocol. Routine laboratory tests, mortality rates, and the need for hospitalization will be measured.
Participants/Inclusion and exclusion criteria
The patient will be included in this study if they:
-Being diagnosed with COVID-19 using the RT-PCR test
- having a breathing rate> 30 per minute
- Arterial blood oxygen saturation levels <90%
- PaO2/FiO2 ratio< 300 mmHg
- Elevated serum levels of interleukin-6
- Patients above 18 years of age
Intervention groups
Control group: Participants in the control group will receive the standard protocol treatment. standard protocol treatment consists of
400 mg Hydroxychloroquine twice daily on day one, followed by 200 mg twice per day.
Intervention group: In addition to the standard protocol treatment, patients in the intervention group will receive 200 micrograms selenium daily for at least 2 weeks. Routine blood tests, the need for hospitalization, and the mortality rate will be measured as the study outcomes.
Main outcome variables
-Routine laboratory tests (changes in ferritin, platelet, WBC, CRP)
-Mortality rates
-the need for hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190418043307N1
Registration date:2020-05-17, 1399/02/28
Registration timing:registered_while_recruiting
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Elham Shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3223 5700
Email address
shafiei-e@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-26, 1399/02/07
Expected recruitment end date
2020-06-27, 1399/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of selenium on recovery of hospitalized patients with COVID-19
Public title
Effect of selenium on covid-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 by RT-PCR test
Respiratory rate above 30 bar per minute
Percentage of peripheral blood oxygen saturation less than 90%
Relative oxygen depletion ratio to arterial oxygen saturation less than 300 mm Hg
Interloquin six blood levels higher Abnormally
age over 18 years
Exclusion criteria:
chronic kidney disease
acute kidney failure
Pregnancy or lactation
History of drug allergy
Pneumonia caused by H influenza, viral infections, bacterial infections, fungi; and other noninfectious types of pneumonia
Chronic liver disease
history of latent or active tuberculosis
patients with acquired immunodeficiency syndrome
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The first phase involves the screening process of potential patients by the researcher to identify the eligibility to participate based on the study inclusion and exclusion criteria. The research assistant will contact eligible participants for enrollment. Those patients who agree to take part in the study will be provided with the information sheet and written consent form before baseline assessment at enrolment. 100 Patients with Covid-19 will be randomized sequentially at the time they provided a baseline assessment. Randomization will be generated by permuted block randomization with allocation concealment. Participants will be divided into intervention or control groups. The control group will receive only the standard protocol treatment, but the intervention group will receive the selenium for 2 weeks in addition to the standard protocol treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
modares Ave
City
Ilam
Province
Ilam
Postal code
6931854919
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.MEDILAM.REC.1399.010
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
Ferritin changes
Timepoint
Daily
Method of measurement
Laboratory
2
Description
platelet
Timepoint
Daily
Method of measurement
Laboratory
3
Description
CRP
Timepoint
Daily
Method of measurement
Laboratory
4
Description
WBC changes
Timepoint
Daily
Method of measurement
Laboratory
Secondary outcomes
1
Description
Reduced mortality
Timepoint
Day 1 to 14
Method of measurement
Record the time of death
Intervention groups
1
Description
Intervention group: In addition to the standard protocol treatment, patients in the intervention group will receive 200 micrograms selenium daily for at least 2 weeks. Routine blood tests, the need for hospitalization, and the mortality rate will be measured as the study outcomes.
Category
Treatment - Drugs
2
Description
Control group: Participants in the control group will receive the standard protocol treatment. standard protocol treatment consists of 400 mg Hydroxychloroquine twice daily on day one, followed by 200 mg twice per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Ali Nazari
Street address
Modares Avenue
City
Ilam
Province
Ilam
Postal code
6931854919
Phone
+98 84 3222 3721
Email
nazari-a@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Dean of Research and Technology, Ilam university of medical science
Full name of responsible person
Dr.Ali Nazari
Street address
Modares Avenue
City
Ilam
Province
Ilam
Postal code
6931854919
Phone
+98 84 3222 3721
Email
nazari-a@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Dean of Research and Technology, Ilam university of medical science
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
Ilam University of Medical Sciences
Full name of responsible person
Ali Nazari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious Disease Specialist
Street address
Modares Avenue
City
Ilam
Province
Ilam
Postal code
6931854919
Phone
+98 84 3222 3721
Email
nazari-a@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ali Nazari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Modares Avenue
City
Ilam
Province
Ilam
Postal code
6931854919
Phone
+98 84 3222 3721
Email
nazari-a@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Elham Shafiei
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
modares Ave
City
Ilam
Province
Ilam
Postal code
6931854919
Phone
+98 84 3222 3721
Email
shafiei-e@medilam.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
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