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The effect of IL-6 inhibitor (Tocilizumab) on the prognosis of covid-19 patients with acute respiratory failure

Protocol summary

Study aim
1-Effect of IL-6 inhibitor in preventing the progression of pulmonary inflammation 2-IL-6 inhibition and cytokine release prevention can subside hypoxic respiratory failure of COVID-19 patients 3-IL- 6 inhibition can reduce mortality of respiratory failure in COVID-19 patients 4- IL-6 inhibition may reduce end organ failure in COVID-19 patients
Design
10 Covid-19 patients with clinical and laboratory confirmation and acute respiratory failure admitted to the intensive care unit of Imam Reza Hospital after ruling out of latent TB by IGRA test, 400 mg Tocilizumab is prescribed as a slow intravenous infusion and the results will be compared with a similar group that did not receive the drug.
Settings and conduct
10 Covid-19 patients with acute respiratory failure in ICU of Imam Reza Hospital after IGRA testing to rule out TB Tocilizumab is given as a slow intravenous infusion of 400mg and the results will be compared with a similar group that does not receive the drug
Participants/Inclusion and exclusion criteria
1. Age range 70-18 years 2. p / f- Pao2 / FIO2 below 300 3. Negative IGRA test 4. IL-6 > 7 EXCLUSION: Acute or chronic renal failure liver cirrhosis Pregnancy latent TB Active gastric ulcer Dissatisfaction
Intervention groups
Patients receive Tocilizumab 400 mg diluted in 150 cc of normal saline in one hour as a single dose, and monitoring for oxygenation and complications in vital organs include : heart, kidneys, CNS, and disorders will be done. monitoring of hemodynamic and duration of mechanical ventilation and final mortality will be performed.
Main outcome variables
Tocilizumab, Pao2, P / F, and respiratory rate, invasive or non invasive mechanical ventilation, systolic blood pressure,urea creatinin , liver test impairment, consciousness, coagulopathy, duration of MV and in hospital mortality

General information

Reason for update
Acronym
Tocilizumab
IRCT registration information
IRCT registration number: IRCT20200406046968N1
Registration date: 2020-04-14, 1399/01/26
Registration timing: prospective

Last update: 2020-04-14, 1399/01/26
Update count: 0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Haleh Mikaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6024
Email address
halehmikaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-21, 1399/02/02
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of IL-6 inhibitor (Tocilizumab) on the prognosis of covid-19 patients with acute respiratory failure
Public title
The effect of IL-6 inhibitor (Tocilizumab) on the prognosis of covid-19 patients with acute respiratory failure hospitalized in Imam Reza Hospital in Tabriz
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-70 P/F<300 Negative IGRA test IL-6>7
Exclusion criteria:
Acute or chronic renal failure Increased liver enzymes 3 times normal with gastrointestinal symptoms or abdominal pain and nausea and jaundice or increased liver enzymes 5 times normal - liver cirrhosis Pregnancy latent TB Active gastric ulcer Dissatisfaction with entering the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Ethics Committee in Research (Studies of Human Subjects), Tabriz University of Medical Scie
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.TBZMED.REC.1399.010

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19 disease

Primary outcomes

1

Description
Percentage of effect of Tocilizumab on COVID-19 patients
Timepoint
Patients receive the drug in a single dose over an hour, and resorption monitoring will be performed to improve oxygenation status and subsequent complications in vital organs of the heart, kidneys, CNS, hemodynamic disturbances, duration of mechanical ventilation, and eventual mortality.
Method of measurement
Clinical and laboratory testing

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with COVID-19, in addition to the usual treatment, receive Tocilizumab IL-6 at a dose of 400 mg diluted in 155 cc of normal saline for one hour as a single dose, and monitoring is improved. Oxygenation status and subsequent complications will occur in vital organs of the heart, kidneys, CNS, hemodynamic disturbances, duration of mechanical ventilation, and eventual mortality.
Category
Treatment - Drugs

2

Description
Control group: Patients with COVID-19 disease who have not received the Tocilizumab IL-6 medication are routinely treated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mikaili, Haleh
Street address
Azadi St., Golgasht St., Imam Reza Hospital.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Adibkiya khosro
Street address
Azadi St., in front of Imam Reza Hospital, Central University Organization
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
danesh@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant Call Corona Covid-19
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mikaili, haleh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Valiasr St., Shariati St., East Kohanmooi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mikaili, haleh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Valiasr St., Shariati St., East Kohanmooi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mikaili, haleh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Valiasr St., Shariati St., East Kohanmooi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@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
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
COVID-19 disease can be fatal in cases that lead to hospitalization, and none of the protocol treatments prescribed in these patients are based on national guidelines and are not definitive. Supportive measures are especially important in the intensive care unit of these patients. In patients who enter this project, all the usual antiviral treatment measures are recommended and supportive measures will be taken in the intensive care unit, and patients will not be deprived of their continuation. Its pros and cons will be available to physicians and authorities for treatment
When the data will become available and for how long
1 month after analyzing the results
To whom data/document is available
For all researchers and physicians in the field of health
Under which criteria data/document could be used
In order to treat and its effective effects on the treatment and criteria of entry and exit of individuals
From where data/document is obtainable
Tabriz University of Medical Sciences website
What processes are involved for a request to access data/document
Data access and its results will be freely accessible.
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