Effect of Selenium on improvement of clinical manifestations and reducing hospitalization in patients with COVID 19
Design
Clinical trial with control group and parallel groups, double blind, with using a permuted balanced block randomization method with the size of blocks 4 and 6, phase 3 on 160 patients, Random sequence will be generated by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of this study is evalution of Selenium effect on reducing clinical manifestation of COVID19. Locality of the study is in Amiralmomenin and Valie-asr hospital of Arak city.In Selenium group, 1 mg of selenium intravenously will be injected for 14 days added to routine treatment protocol and in control group distilled water that is similar to Selenium will be given to the patients (in addition to routine treatment) for 14 days, too.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with moderate COVID 19 infection
Patients with severe COVID 19 infection
Patients who have informed consent
Non-inclusion criteria:
Renal failure (Glomerular filtration rate 70 or under)
Intervention groups
In Selenium group, 1 mg of selenium intravenously will be injected for 14 days added to routine treatment protocol and in control group distilled water that is similar to Selenium will be given to the patients (in addition to routine treatment).
Main outcome variables
Need of mechanical ventilation and duration of using, length of hospitalization, length of ICU stay, duration of fever, level of SpO2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049175N9
Registration date:2021-09-06, 1400/06/15
Registration timing:prospective
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Selenium on improvement of clinical manifestations and reducing hospitalization in patients with COVID 19
Public title
Effect of Selenium on improvement of clinical manifestations and reducing hospitalization in patients with COVID 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate COVID 19 infection
Patients with severe COVID 19 infection
Patients who have informed consent
Exclusion criteria:
Renal failure (Glomerular filtration rate 70 or under)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Sequences web randomization (www.graphpad.com) dual group for creation of simple randomization and for concealment, closed envelope method with random sequence (SNOSE) will be used. Random sequences will be written on the cards and then sequentially put in the envelopes. In order to preserve random sequences, the outer surface of the envelopes are numbered, respectively. Finally, the lid of the envelopes will be paste and place inside the boxes, respectively. At the time of participants registration, one of the envelopes will be open and the allocation group will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients have informed consent to entrance to study, but they do not know about the kind of drugs have been received . The required drugs will be prescribed by the infectionist and anesthesiologist, but the person who will gather the data of patients outcomes will be unaware about the patients group and the kind of received drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-08-08, 1400/05/17
Ethics committee reference number
IR.ARAKMU.REC.1400.123
Health conditions studied
1
Description of health condition studied
Coronavirus disease 2019 (COVID 19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
2
Description of health condition studied
Selenium
ICD-10 code
E59
ICD-10 code description
Dietary selenium deficiency
Primary outcomes
1
Description
Length of hospitalization
Timepoint
After discharge
Method of measurement
Days
2
Description
Length of ICU stay
Timepoint
After discharge
Method of measurement
Days
3
Description
Duration of using mechanical ventilation
Timepoint
After discharge
Method of measurement
Days
4
Description
Duration of fever
Timepoint
After discharge
Method of measurement
Days
5
Description
Level of atrial oxygen saturation (SpO2)
Timepoint
Daily from first day to 14th day
Method of measurement
pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 mg of selenium intravenously will be injected for 14 days added to routine treatment protocol.
Category
Treatment - Drugs
2
Description
Control group: Distilled water that is similar to Selenium will be given to the patients for 14 days (in addition to routine treatment).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Hossein Sarmadian
Street address
Amiralmomenin hospital street, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Valie-asr hospital
Full name of responsible person
Behnam Mahmoodieh
Street address
Valie-asr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Hossein Sarmadian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Parastar square, Rah-ahan square, Shiroudi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
hosseinsarmadian2015@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Behnam Mahmoodieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valie-asr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
behnammahmoudye@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
میدان ولیعصر، بیمارستان ولیعصر
City
Arak
Province
Markazi
Postal code
3814957558
Phone
0098 86 32222003-8
Email
sh.valibak@yahoo.com
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