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Evaluation of interferon treatment in high-risk covid19 patients in Qom

Protocol summary

Study aim
Determination of interferon treatment in 19-year-old patients with high risk in Qom province.
Design
Clinical trial with control group, with parallel, non-blind, randomized group, phase 2 on 60 patients. Blockchain was used for randomization.
Settings and conduct
Patients admitted to Shahid Beheshti and Forghani Hospitals with COVID 19 By receiving oxygen by reserve bag, they have less than 94% oxygen saturation Provided you have an entry criterion, According to the pilot study, in two groups of 30 people, it was selected as control and intervention.And enter the study 24 hours after hospitalization And randomly enter the blockade allocation into one of two treatment groups; n addition to receiving treatment protocol from the Ministry of Health, the intervention group will be treated with interferon after obtaining informed consent, and the second group will be treated only with the protocol of the Ministry of Health.
Participants/Inclusion and exclusion criteria
Entry requirements: Adulthood, laboratory confirmation of Covid19 infection, dysfunction of the new organ related to Covid19 Conditions of non-entry: intent to commit suicide, sensitivity, or drug sensitivity reaction, ALT above 5 times normal. Use of drugs that are contraindicated with lopinavir / ritonavir, pregnancy, known HIV infection, all vulnerable groups.
Intervention groups
In addition to receiving treatment protocol from the Ministry of Health, the intervention group underwent interferon treatment after obtaining conscious consent. And the second group is only treated by the protocol of the Ministry of Health.
Main outcome variables
Primary consequences (death within 30 days of hospitalization) and secondary consequences, for example, Results of RT-PCR in lower respiratory samples

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20160118026097N3
Registration date: 2020-05-31, 1399/03/11
Registration timing: registered_while_recruiting

Last update: 2020-05-31, 1399/03/11
Update count: 0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Jamshid Vafaeemanesh
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 252931933
Email address
j.vafaeemanesh@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of interferon treatment in high-risk covid19 patients in Qom
Public title
The effect of interferon on the treatment of covid19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmation of Covid19 infection with reverse transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source A new organ dysfunction related to Covid19 Being an adult
Exclusion criteria:
Intention to commit suicide (interfering with interferon (IFN) -b1b). Sensitivity or sensitivity reaction to Lupinavir / Ritonavir or IFN-β1b recombinant, including toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema or angioedema syndrome. ALT above 5 times normal Use of drugs that are contraindicated with lopinavir / ritonavir and should not be substituted or discontinued during the study period, such as CYP3A inhibitors. pregnancy.Eligible female participants are tested at gestational age before enrolling in the study for pregnancy. HIV Vulnerable groups
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through block allocation
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of qom University of Medical Sciences
Street address
qom
City
qom
Province
Ghoum
Postal code
3719964797
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.MUQ.REC.1399.089

Health conditions studied

1

Description of health condition studied
COVID19
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
death within 30 days of hospitalization
Timepoint
every day
Method of measurement
View

Secondary outcomes

1

Description
Days without organ support (for example, supplemental O2, mechanical ventilation, dialysis and vasopressors)
Timepoint
Time interval: 28 days
Method of measurement
View

2

Description
Results of RT-PCR in lower respiratory samples
Timepoint
Time interval: At the time of entering the study and one week after treatment and repetition every week until the negative sample of the period
Method of measurement
test

3

Description
Body Failure Assessment Scores (SOFA)
Timepoint
Time frame: days 1, 3, 5, 7, 14 and 28)
Method of measurement
check list

Intervention groups

1

Description
Intervention group: In addition to receiving treatment protocol from the Ministry of Health, after obtaining informed consent, it will be treated with interferon.
Category
Treatment - Drugs

2

Description
Control group: They are treated only by the protocol of the Ministry of Health
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
beheshti & forghani hospital
Full name of responsible person
hasan adeli
Street address
beheshti blv
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
adeli@muq.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
hasan adeli
Street address
beheshti blv
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
adeli@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
jamsheed vafaeemanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
beheshti blvd
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
jvafaeemanesh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
jamshid vfaeemanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
beheshti blvd
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
jvafaeemanesh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
jamshid vafaeemanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
beheshti blvd
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
jvafaeemanesh@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
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
According to the rules of the COPE
From where data/document is obtainable
jvafaeemanesh@yahoo.com
What processes are involved for a request to access data/document
Email the responsible author
Comments
no
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