Evaluting the therapeutic and adverse effects of Interferon beta 1-a subcutaneous administration in patients with new Coronavirus (COVID-19)
Design
Non-controlled clinical trial
Settings and conduct
Dr. Masih Daneshvari Hospital
Participants/Inclusion and exclusion criteria
Patients with confirmed COVID-19 who are in severe phase and did not have chronic kidney or liver diseases and are not pregnant or breastfeeder.
Intervention groups
Patients receive Hydroxychloroquine 400 mg P.O. BID and Oseltamivir 75 mg P.O. BID and Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for five days. Also, patients receive Interferon beta-1a 44 mg every other day S.C until 10 days.
Chronic kidney Disease
Pregnancy or breastfeeding
Drug allergy history
Pneumonia due to influenza virus, bacterial pneumonia, fungal pneumonia, and noninfectious causes
Chronic liver disease
Acute kidney injury
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
National Research Institute of Tuberculosis and Lung Diseases
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.SBMU.NRITLD.REC.1398.102
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Clinical response to therapy
Timepoint
Daily
Method of measurement
Clinical symptoms
Secondary outcomes
1
Description
Hospitalization duration
Timepoint
At admission time and discharge time
Method of measurement
Clinical records
2
Description
Lung radiology changes
Timepoint
At admission time and seven and 14 days later
Method of measurement
Computed tomography
3
Description
Adverse Drug Reaction
Timepoint
Daily
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Tab Hydroxychloroquine 400 mg P.O. BID for five days plusTab Oseltamivir 75 mg P.O. BID for five days plus Tab Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for five days plus Interferon beta-1a 44 mg every other day S.C for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 3000
Fax
+98 21 2610 9490
Email
info@nritld.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Payam Tabarsi
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 3000
Email
tabarsi@nritld.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2610 9490
Fax
+98 21 8887 3704
Email
f_dastan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Payam Tabarsi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 3000
Email
tabarsi@nritld.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Saffaei
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway., Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
alisaffaei.ss@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document