Evaluating the efficacy and safety of Remdesivir (Brand) in comparison to generic remdesivir
Design
Prospective double-blind clinical trial with parallel randomized groups using permuted block randomization method. This is a phase 3 clinical trial on 120 patients.
Settings and conduct
Place of study: Masih Daneshvari Hospital. How to do the study: 120 patients with COVID-19, using permuted block randomization will be divided in to two groups. The main investigator and the patients will be blind to the study groups.
Participants/Inclusion and exclusion criteria
Patients between 18 and 100 years old who have laboratory confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction) and CT scan and are severally ill, will be included in the study. Furthermore, patients should have a SaO2/SPO2≤94% on room air or a ratio of Pa02/Fi02<300mgHg, to be included in the study. The exclusion criteria are included pregnancy, breastfeeding, severe liver and renal disease, and drug interaction with remdesivir.
Intervention groups
120 patients are going to be divided in to two groups using permuted block randomization; each group will contain 60 patients. First group will receive remdesivir (Veklury) 200 mg for the first day then 100 mg for day 2 to 5. The second group will receive generic remdesivir (Ronak Daru) 200 mg for day one then 100 mg from day 2 to 5.
Main outcome variables
Time to clinical improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N28
Registration date:2021-10-21, 1400/07/29
Registration timing:registered_while_recruiting
Last update:2021-10-21, 1400/07/29
Update count:0
Registration date
2021-10-21, 1400/07/29
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy and safety of remdesivir in severe COVID-19 in hospitalized patients
Public title
Evaluating the effects of remdesivir in severe COVID-19 in hospitalized patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 18 years old
Confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction)
Lung CT scan confirming lung involvement
Hospitalized with SaO2/SPO2≤94% in room air or having Pa02/Fi02 <300mgHg
Becoming symptomatic within the past two weeks
Exclusion criteria:
Severe liver disease (Child Pugh score ≥ C, AST>10 times upper limit)
Pregnancy
Breastfeeding
Sever renal failure ( estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving dialysis
Drug interactions (Methimazole, chloroquine, hydroxychloroquine)
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
120 COVID-19 patients who are hospitalized in the COVID-19 ward of Masih Daneshvari Hospital will be randomized using permuted block randomization by Sealedenvelope.com site. The list of randomization containing 30 blocks each consisting 4 will be available for randomizer for assigning the drug and the control group. Following entering the study, cases will be randomized to study groups based on the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigator and participants are unaware of the study groups. The drug vials will be concealed by uniform labels and separated and administered by coding system.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of National Research Institute of Tuberculosis and Lung Diseases-Shahid B
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.SBMU.NRITLD.REC.1400.025
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Time to clinical improvement
Timepoint
Daily until day 5
Method of measurement
Six-category ordinal scale
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
Daily until discharge
Method of measurement
Medical record
2
Description
Number of days admitted to critical care unit
Timepoint
Daily until discharge
Method of measurement
Medical record
3
Description
Length of time in which patient needs oxygen therapy
Timepoint
Daily until discharge
Method of measurement
Medical record
4
Description
Length of time in which patient needs mechanical ventilation
Timepoint
Daily until discharge
Method of measurement
Medical record
5
Description
Mortality
Timepoint
Daily until discharge
Method of measurement
Medical record
Intervention groups
1
Description
Intervention group: 60 patients will receive remdesivir (Veklury) 200 mg day one then 100 mg day 2 to 5.
Category
Treatment - Drugs
2
Description
Intervention group: 60 patients will receive generic (Ronak Daru) remdesivir 200 mg day one then 100 mg day 2 to 5.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
f_dastan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.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
Hamidreza Jamaati
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
hamidjamaati@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
f_dastan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Mirshafiei Langari
Position
Hospital pharmacist
Latest degree
Medical doctor
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 2712 2066
Email
z.mirshafei@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 months after publishing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
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
Official letter to the researchers through Email (fzh.dastan@gmail.com).