Determination and comparison of the effect of two antiviral drugs (interferon beta 1A and interferon alpha 2A) on the prognosis of patients with COVID 19
Design
Randomized, Placebo-Controlled Clinical Trial with 80 patients
Settings and conduct
This study will conduct on patients with COVID- 19 who admitted in the ٍEmam Hasan hospital of Bojnord and Shariati hospital of Mashhad. Eligible patient will be randomized in 4 groups, two groups will receive interferon (alpha or beta) and two group will receive placebo. the subjects, investigator, and the data analysts will remain blinded
Participants/Inclusion and exclusion criteria
Inclusion criteris:
•Adult over 18 years and unpregnant women
•Clinical diagnosis of COVD-19
exclusion criterion
•History of allergy to human albumin or interferon
Intervention groups
Intervention group 1: patients who will receive standard care plus 4 consecutive doses of intramuscular injection of beta-interferon (each vial contains 30 micrograms of interferon equivalent to 6 million international units
Intervention group 2: patients who will receive standard care plus 2 doses of subcutaneous injection of Alpha-interferon (each vial contains 180 micrograms of interferon) with 7 day interval.
Control group 1: patients who will receive standard care plus beta-interferon placebo
Control group 2: patients who will receive standard care plus alpha-interferon placebo
Main outcome variables
Body temperature
•Respiratory rate
•The ratio of arterial oxygen partial pressure to fractional inspired oxygen
•Blood gas level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161206031256N3
Registration date:2020-06-02, 1399/03/13
Registration timing:registered_while_recruiting
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Maryam Khoshkhui
Name of organization / entity
Mashhad university
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2770
Email address
khoshkhuim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of two interferon alpha and beta antiviral drugs on the prognosis of patients with COVID 19
Public title
Using interferon to treat COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult over 18 years
Clinical diagnosis of COVID-19
Exclusion criteria:
History of allergy to human albumin or interferon
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization using the envelope placement method
Blinding (investigator's opinion)
Triple blinded
Blinding description
Eligible patient will be randomized in 4 groups, two groups will receive interferon (alpha or beta) and two group will receive placebo. the subjects, investigator, and the data analysts will remain blinded
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Next to the cinema Hoveizeh , University Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.MUMS.REC.1399.219
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
RA01.0.
ICD-10 code description
the code for the confirmed diagnosis of COVID-19
Primary outcomes
1
Description
Body temperature
Timepoint
Before intervention, on day of 1 until discharge with 3 day interval
Method of measurement
Thermometer, Celsius
2
Description
Respiratory rate
Timepoint
Before intervention, on day of 1 until discharge with 3 day interval
Method of measurement
Pulse oximeter, Breaths per minute
3
Description
The ratio of arterial oxygen partial pressure to fractional inspired oxygen
Timepoint
Before intervention, on day of 1 until discharge with 3 day interval
Method of measurement
Ventilator, Millimeter of mercury (mmHg)
4
Description
Blood gas level
Timepoint
Before intervention, on day of 1 until discharge with 3 day interval
Method of measurement
Blood Gas Analyzer, percent
Secondary outcomes
1
Description
Lymphocyte count
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Cell counter, Cell per milliliter
2
Description
Lymphocyte count
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Cell counter, Cell per milliliter
3
Description
C-reactive protein level
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Clinical Biochemistry Analyzer, milligram per deciliter
4
Description
Erythrocyte Sedimentation Rate
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
ESR analyzer, millimeter per hour
5
Description
Alanine aminotransferase Level
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Autoanalyzer, Unit per liter
6
Description
Aspartate aminotransferase Level
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Autoanalyzer, Unit per liter
7
Description
Total/ conjugated bilirubin levels
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Autoanalyzer, Milligram per deciliter
8
Description
Creatinine
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Autoanalyzer, Milligram per deciliter
9
Description
Creatine kinase myocardial band (CK-MB)
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
Autoanalyzer, international unit per liter
10
Description
Troponin
Timepoint
Before intervention, on day of 1 until discharge, with 3 day interval
Method of measurement
enzyme-linked immunosorbent assay, nanogram per mililitere
11
Description
Hospitalization time
Timepoint
Admission time until discharge
Method of measurement
ِDay
12
Description
Mortality rate
Timepoint
on day of 14 and 28 after intervention
Method of measurement
Mortality formula
13
Description
National early warning score 2
Timepoint
On day of 1 and 7 after intervention
Method of measurement
Formula, scoring
14
Description
Polymerase chain reaction
Timepoint
on day of 1 and 14 after intervention (if PCR on day of 1 was positive)
Method of measurement
Thermocyclers
15
Description
Chest scan
Timepoint
On day of 10 after intervention
Method of measurement
Scan
Intervention groups
1
Description
Intervention group 1: patients who will receive standard care plus 4 consecutive doses of intramuscular injection of beta-interferon (each vial contains 30 micrograms of interferon equivalent to 6 million international units
Category
Treatment - Drugs
2
Description
Intervention group 2: : patients who will receive standard care plus 2 doses of subcutaneous injection of Alpha-interferon (each vial contains 180 micrograms of interferon) with 7 day interval.
Category
Treatment - Drugs
3
Description
Control group 1: patients who will receive standard care plus beta-interferon placebo
Category
Placebo
4
Description
Control group 2: patients who will receive standard care plus alpha-interferon placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Maryam khoshkhui
Street address
Emam reza 1, Torghabeh, vakil abad Blv, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9351899983
Phone
+98 51 3551 0010
Fax
Email
dshh.pr@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hassan hospital
Full name of responsible person
Maryam Khoshkui
Street address
Imam Hassan hospital, Pardis Town Bojnourd, North Khorasan, Iran
City
Bojnourd
Province
North Khorasan
Postal code
9351899983
Phone
+98 58 3151 0000
Email
Imamhasan@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology University, Ghoreishi Building, University Avenue, next to the cinema Hoveize, , Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?