Determination and comparison of the effect of beta interferon and dexamethasone in the treatment of patients with Covid-19
Design
A single-blind randomized clinical trial with a control group and parallel groups was performed on 160 patients. Block randomization method was used for randomization.
Settings and conduct
This study is being conducted at Shahid Jalil educational Hospital in Yasuj. Routine drugs with the possibility of affecting Covid 19 symptoms were used in both intervention 1 (Combination of Remedcivir, Interferon, and Dexamethasone) and intervention 2 or Control (Remedcivir and Dexamethasone) groups.
Participants/Inclusion and exclusion criteria
1. Definitive diagnosis of covid- 19 by infectious disease specialist and a positive PCR and spiral CT scan of the lung.
2. Inpatients who are at least 18 years old.
3. Hospitalized patients with pulmonary involvement in CT Scan if not intubated and not ventilated with NIV mask.
4. No history of pancytopenia.
5. Patients with a GFR of more than 30%.
6. Patients who are not pregnant.
8. Absence of liver inflammation.
Intervention groups
The intervention group1 includes patients who will receive a combination of Remedsivir, Interferon, and Dexamethasone, and the intervention group2 (Control) includes patients who will receive a combination of Remedsivir, and Dexamethasone.
Main outcome variables
The length of hospital stay
Patient mortality.
O2 saturation
General information
Reason for update
Acronym
مقایسه داروی بتا اینترفرون و دگزامتازون
IRCT registration information
IRCT registration number:IRCT20150622022869N9
Registration date:2022-07-02, 1401/04/11
Registration timing:retrospective
Last update:2022-07-02, 1401/04/11
Update count:0
Registration date
2022-07-02, 1401/04/11
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of interferon-beta 1a and Dexamethasone in hospitalized patients with Covid - 19.
Public title
Comparison of Interferon-beta-1a and Dexamethasone on hospitalized patients with Covid-19.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of covid-19 by infectious disease specialist with a positive PCR and spiral ct scan of the lung.
Hospitalized patients who are at least 18 years old.
Exclusion criteria:
Pregnant women
Patients with GFR less than 30%.
Patient with a history of Pancytopenia.
Increased ALT more than 10 times.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be used.
A total of 176 patients with Covid-19 who meet the inclusion criteria will be selected and randomly assigned to the two groups of intervention 1 and intervention 2. In block randomization, according to the total number of 176 patients and the existence of two groups, blocks with sizes of 2, 4, and 6 will be used. For example, if the size of block is 2, we will have two modes AB and BA (A and B are intervention groups 1 and intervention 2). In order to create sequences and concealment, online software with the following address will be used, and a special randomization code will be generated.
Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 5 Jun 2022
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person evaluating the outcome variables is unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی یاسوج
Street address
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.YUMS.REC.1400.119
Health conditions studied
1
Description of health condition studied
COVID - 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Arterial oxygen saturation
Timepoint
At the time of admission and discharge of the patient
Method of measurement
pulse oximeter device
Secondary outcomes
1
Description
Mortality rate
Timepoint
At the end of the intervention and completion of sampling
Method of measurement
By comparing the number of deaths in each group
2
Description
Duration of hospitalization
Timepoint
On the day of discharge from the hospital
Method of measurement
Number of hospitalization days
Intervention groups
1
Description
Intervention group: (combination of three drugs Remedsivir, Interferon, and Dexamethasone) Remedsivir drugs with a dose of 200 mg in the initial dose and then 100 mg daily for 5 days, Interferon-beta 1 alpha is given as a subcutaneous injection every other day for 4 doses (each vial contains 30 micro-grams of interferon is equivalent to 6 million international units) and dexamethasone at a dose of 8 mg daily intravenously.
Category
Treatment - Drugs
2
Description
Intervention group 2: Combination of Remdesivir and Dexamethasone) Remdesivir with a dose of 200 mg in the initial dose and then 100 mg daily for 5 days, and Dexamethasone at a dose of 8 mg daily intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil Hospital in Yasuj
Full name of responsible person
Moslem Sedaghattalab
Street address
Shahid Qharani Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
M.sedaghattalab@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Street address
بلوار شهید مطهری
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
M.sedaghattalab@YUMS.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasuj 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
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
M.sedaghattalab@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
M.sedaghattalab@yums.ac.ir
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
M.sedaghattalab@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
M.sedaghattalab@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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