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The assessment of therapeutic effect of β-interferon and Methylprednisolone in patients with COVID- 19: A quasi-experimental, double-blind, placebo-controlled study

Protocol summary

Study aim
The aim of this study was to evaluate the effectiveness of combination therapy of beta interferon and methylprednisolone in comparison with beta interferon on the recovery of patients with Covid-19.
Design
The double-blind clinical trial, sham- controlled clinical trial with parallel groups
Settings and conduct
People with Covid-19 admitted to Shahid Sadoughi Hospital in Yazd were divided into two groups after classification and matching based on age and sex. Both groups received medication on the first day of hospitalization according to the national protocol. During the days of hospitalization, the intervention group received 500 mg of methylprednisolone weekly and 0.44 mg of β-interferon daily subcutaneously. The control group received 0.44 mg of beta interferon daily subcutaneously.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18- 80 years old, Covid-19 infection based on high-resolution computed tomography findings, progressive and severe hypoxia based on blood oxygen saturation level less than 88% with a reservoir bag mask and flow of 15 liters, exacerbation of lymphopenia during hospitalization. Exclusion criteria: cardiovascular patients, grade 3 and more liver cirrhosis, autoimmune diseases, severe depression and psychosis, organ transplantation, kidney failure, pregnancy.
Intervention groups
Both groups received medication on the first day of hospitalization according to the national treatment protocol. For the intervention group, 500 mg methylprednisolone was given weekly and 0.44 mg β- interferon was administered subcutaneously daily. The control group received 0.44 mg of β- interferon subcutaneously daily.
Main outcome variables
Body temperature, blood pressure, respiration rate, O2 saturation, white blood cell, neutrophil, lymphocyte, platelet, erythrocyte sedimentation rate, C-reactive protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048514N1
Registration date: 2020-10-10, 1399/07/19
Registration timing: retrospective

Last update: 2020-10-10, 1399/07/19
Update count: 0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Fatemeh sadat Aghaei meybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
dr.meybodi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of therapeutic effect of β-interferon and Methylprednisolone in patients with COVID- 19: A quasi-experimental, double-blind, placebo-controlled study
Public title
Effect of β-interferon and methylprednisolone in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18- 80 years Covid-19 infection based on high-resolution computed tomography findings Progressive and severe hypoxia based on blood oxygen saturation level less than 88% with a reservoir bag mask and flow of 15 liters Exacerbation of lymphopenia during hospitalization
Exclusion criteria:
Cardiovascular patients Grade 3 and more liver cirrhosis Autoimmune diseases Severe depression and psychosis Organ transplantation Kidney failure Pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding was performed without informing the patients about the type of treatment and with the consent of each patient's family. The selected participant in an intervention group is informed about the implementation and duration of the intervention, but does not know the type of intervention and the main purpose of the study. An independent statistical researcher from the study team assigned eligible patients in a 1: 1 ratio to the interferon beta and methylprednisolone combination group or the interferon beta group. An independent pharmacist from the experimental team (from the pharmacy of Shahid Sadoughi Hospital) placed the labels with the study ID on separate numbered packages for the combined treatment of interferon beta and methylprednisolone and interferon beta based on a list (M & C codes). Not all clinical and laboratory staff, and participants were aware of the type of treatment assigned to each individual, and only the pulmonologist responsible for each patient was aware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of medical sciences
Street address
Bahonar Sq., Shahid Sadoughi Ave., Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.SSU.REC.1399.040

Health conditions studied

1

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

Primary outcomes

1

Description
Body temperature
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Vital Sign Monitoring Device

2

Description
Blood pressure
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Blood pressure cuff monitoring vital signs

3

Description
Respiration rate
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Vital Sign Monitoring Device

4

Description
O2 saturation
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Pulse oximeter

5

Description
White blood cells
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurements are performed using an automatic blood cell counting device.

6

Description
Neutrophil
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurements are performed using an automatic blood cell counting device.

7

Description
Lymphocytes
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurements are performed using an automatic blood cell counting device.

8

Description
Platelet
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurements are performed using an automatic blood cell counting device.

9

Description
Erythrocyte Sedimentation Rate
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurement is done by centrifugation.

10

Description
C-Reactive Protein
Timepoint
At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis
Method of measurement
Measurements are performed by ELISA method.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and one dose of 400 mg hydroxychloroquine. In the intervention group, 500 mg of methylprednisolone was administered weekly and 0.44 mg of β-interferon daily subcutaneously.
Category
Treatment - Drugs

2

Description
Control group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and a dose of 400 mg hydroxychloroquine. In the control group, 0.44 mg of β-interferon was administered subcutaneously daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Shahid Sadoughi hospital
Full name of responsible person
Fatemeh sadat Aghaei meybodi
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
dr.meybodi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Sq., Shahid Sadoughi Ave., Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2136
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh sadat Aghaei meybodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
dr.meybodi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh sadat Aghaei meybodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
dr.meybodi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh sadat Aghaei meybodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
dr.meybodi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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