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Effective of Elman tablet on illness severity and length of hospital stay in the patients with COVID-19 infection

Protocol summary

Study aim
This study aimed to determine the effects of Elman tablet on illness severity and length of hospital stay patients with Covid-19 infection.
Design
This study is a three-group clinical trial, parallel and without blinding, and phase three of the clinical trial. Patients are divided into control, intervention and placebo groups based on a random number table. Pilot study is performed to determine the sample size.
Settings and conduct
The study population is patients referring to Corona ward of Imam Khomeini Hospital in Esfarayen. After conducting a pilot study and determining the sample size, patients are divided into three groups.Elman Tablet (60 mg) are given orally three times a day for up to six days. In the placebo group, the placebo is prescribed three times a day with the same appearance as the main drug. The control group also receives routine treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients diagnosed with COVID-19 disease based on PCR test and their level of consciousness should be 15. Exclusion criteria: Pregnancy and lactation, Connect the patient to the ventilator, Low blood pressure at the beginning of the study , Has a history of gastrointestinal bleeding or active bleeding in the body, Patients with immunodeficiency (under chemotherapy and patients with autoimmune diseases)
Intervention groups
Intervention group: In addition to routine treatment,Elman Tablet (60 mg) is given orally three times a day for up to six days. In the placebo group: The placebo is given three times a day with a similar appearance to the main drug containing maltodextrose. Control group: Patients receive routine treatment
Main outcome variables
Primary outcome: severity of the illness based on changes in CBC, CRP test levels, need for supplemental oxygen, SPO2 level, physical symptoms (fever, cough, sore throat and myalgia) Secondary outcome: length of hospital stay

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200609047707N1
Registration date: 2020-06-24, 1399/04/04
Registration timing: prospective

Last update: 2020-06-24, 1399/04/04
Update count: 0
Registration date
2020-06-24, 1399/04/04
Registrant information
Name
Essa Towhidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3724 1702
Email address
issatohidi201648@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-09, 1399/04/19
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effective of Elman tablet on illness severity and length of hospital stay in the patients with COVID-19 infection
Public title
Effective of Elman tablet on COVID-19 infection severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with COVID-19 disease based on PCR test The level of consciousness should be 15
Exclusion criteria:
Pregnancy and lactation Connect the patient to the ventilator Low blood pressure at the beginning of the study (below 80/12) Has a history of gastrointestinal bleeding or active bleeding in the body Patients with immunodeficiency (under chemotherapy, organ transplantation and bone marrow transplantation, and patients with autoimmune diseases)
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. Random units are each of patients infected with covid-19 that admitted to the emergency department. Also, The randomization tool is a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified.
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 Esfarayen faculty of medical sciences
Street address
Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.ESFARAYENUMS.REC.1399.003

Health conditions studied

1

Description of health condition studied
Patients infected with Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Illness severity
Timepoint
Every 12 hours for six day
Method of measurement
Using the checklist

Secondary outcomes

1

Description
Length of hospital stay
Timepoint
It is controlled daily
Method of measurement
Calculate the number of days hospitalized within the corona ward

Intervention groups

1

Description
First Intervention group (Elman Tablet): The tablet has an effective drug combination of L-cysteine, C3H7NO2S chemical formula and chemical structure of HS-CH2-CH (NH2) -COOH with L stereochemistry and a molar mass of 121.16 grams per mole and soluble in water. Each Elman tablet contains 60 mg of L-cysteine (Pharmaceutical active ingredient). Each patient takes this pill three times every 8 hours. It is recommended to take this medicine at least two hours apart from the prescription of the routine medications for six days. Manufacturing Company is Simorgh Attar Neishabour Pharmaceutical . It is prescribed along with routine drugs for treatment of covid-19.
Category
Treatment - Drugs

2

Description
Second Intervention group (Placebo): It contains a combination of malodextrin, an oligo or polysaccharide with the formula C6nH10n + 2 O5n + 1, and is obtained from starch hydrolysis in a simple process. The powder is white and soluble in water. The placebo is given with a very similar appearance to the original medicine and is given orally every 8 hours for six days. Drugs associated with the treatment of Qovid-19 disease are prescribed according to the routine.
Category
Placebo

3

Description
Control group: Drugs associated with the treatment of Covid-19 disease are prescribed according to the routine( hydroxychloroquine 200 mg and Kaletra).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital of Esfarāyen
Full name of responsible person
Essa Tohidi
Street address
Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
Issatohidi201648@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Eshagh Ildarabadi
Street address
Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
Info@esfrums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Member of Esfarayen faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
9661777944
Phone
0098 5831550000- 602
Email
S.j.hoseini2016@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Essa Tohidi
Position
Deputy for treatment in Esfarayen faculty of medical sciences
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Esfarayen faculty of medical sciences, imam Reza Street, Esfarayen town, North Khorasan, Iran
City
Esfarayen
Province
North Khorasan
Postal code
96617-77944
Phone
+98 58 3722 9050
Email
Issatohidi201648@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Member of Esfarayen faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
96617-77944
Phone
0098 58 3155 0000-602
Email
S.j.hoseini2016@gmail.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Document will be registered "Pajouhan" system after completion of the study . Also, participants general information and the effectiveness of interventions will be recorded in the article.
When the data will become available and for how long
Accessibility after publish of article
To whom data/document is available
People interested in medicine scope
Under which criteria data/document could be used
People looking for ways to covid-19 recovery who can access the data.
From where data/document is obtainable
Esfarāyen faculty of medical sciences, imama Reza Street, Esfarāyen, North Khorasan
What processes are involved for a request to access data/document
They can access to data through below email as soon as possible s.j.hoseini2016@gmail.com
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