Determination of efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2
Design
Clinical trial phase II
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: ُTreatment
Estimated Enrollment: 30 in each arm
Settings and conduct
Imam Hossein Hospital affliated to Shahid Beheshti University of Medical Sciences. Volunteers will be randomly assigned into two intervention groups (A and B) and will be admitted according to the study protocol. Medical Care will be provided by physicians . Blindness will be done to the principle investigator of the study as well as the statistical analyzer
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Written informed consent;
SARS-CoV)-2 infection confirmed by PCR test ≤ 4 days before randomization;
Currently hospitalized with fever;
SpO2<94%;
Radiographic evidence of pulmonary infiltrates
Exclusion Criteria:
Participation in any other clinical trial of an experimental trial for COVID-19
History of taking other antivirals aginst COVID-19 in the last 24 hours at the enrollment in the study
Multi-organ failure
Need mechanical ventilation at screening
Liver enzymes>5 upper limit Normal
GFR< 30 mL/min
Concurrent treatment with other agents with potential important drug interaction with Sofosbuvir
Pregnant woman or man who his spouse is pregnant
Intervention groups
Groupَ A: Experimental:
Participants will receive standard of care therapy continued together with Sofosbuvir 400 mg single dose daily for 5 days
Group B: Experimental:
Participants will receive standard of care therapy continued together with Sofosbuvir 400 mg single dose daily for 10 days
Main outcome variables
Normalization of fever( ≤37.2 °C oral, or ≤36.6 °C armpit, or ≤37.8 °C rectal
AND oxygen saturation (≥94% on room air), sustained for at least 72 hours within 14 days from initiation of Trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200328046882N1
Registration date:2020-04-05, 1399/01/17
Registration timing:registered_while_recruiting
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
Registrant information
Name
Mostafa Alavi -Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 3634
Email address
mosalavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-07-06, 1399/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial
Public title
Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent prior to performing study procedures
(SARS-CoV)-2 infection confirmed (PCR) test ≤ 4 days before randomization
Currently hospitalized with fever
Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening
Radiographic evidence of pulmonary infiltrates
Exclusion criteria:
Participation in any other clinical trial of an experimental treatment for COVID-19
Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
Evidence of multi-organ failure
Requiring mechanical ventilation at screening
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
Creatinine clearance <30mL/min
pregnant woman or man who his spouse is pregnant
Coadministration of amiodarone, HIV Protease Inhibitors, rifabutin or rifapentine , phenobarbital or oxcarbazepine
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in the study arms will be done by using table of random numbers, without concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation of the patients in to groups A or B will be randomized. Physicians who involve in the care of the patients will not be blinded. Principle Investigator who will assess the outcomes and the statistician who will analyze the data all will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical sciences
Street address
5th Floor, Bldg No 2, Shahid Beheshti Medical Sciences University Arabi Ave,Velenjak Tehran ,IRAN
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2020-03-28, 1399/01/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.001
Health conditions studied
1
Description of health condition studied
SARS-CoV-2 َassociated SARI
ICD-10 code
U07.1
ICD-10 code description
SARS-CoV-2
Primary outcomes
1
Description
Temperature( < 36.6 °C armpit, or < 37.2 °C oral, ) without using antipyretic drugs sustained for at least 72 hours
Timepoint
ِDuring 14 days after enrollment in the study
Method of measurement
Digital Thermometer
2
Description
Spo2>= 94% (at room air) sustained for at least 72 hours without Oxygen therapy
Timepoint
During 14 days after enrollment in the study
Method of measurement
Pulse Oximeter
Secondary outcomes
1
Description
All causes mortality
Timepoint
During 14 days after enrollment in the study
Method of measurement
As defined in ACLS protocol
2
Description
Length of stay in hospital
Timepoint
Time duration between admission date and discharge date
Method of measurement
Calculation
3
Description
Transfer to ICU due to need of mechanical ventilation
Timepoint
During 14 days after enrollment in the study
Method of measurement
Patient Chart review
4
Description
Report of Sofosbuvir adverse reactions need to stop the treatment
Timepoint
During 14 days after enrollment in the study
Method of measurement
physician judgement
Intervention groups
1
Description
Intervention group َ: Sofosbuvir 400mg OD for 5 days+ standard treatment
Category
Treatment - Drugs
2
Description
Intervention group: Sofosbuvir 400mg OD for 10 days+ standard treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinical Research Development Center-Imam Hossein Hospital affliated to Shahid Beheshti University o
Full name of responsible person
Mostafa Alavi-Moghaddam
Street address
Clinical Research Development Center, Imam Hossein Hospital, Shahid Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Fax
+98 21 7754 3634
Email
mosalavi@sbmu.ac.ir
Web page address
https://ehcrdc.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
5th floor,Bldg No 2, ُShahid Beheshti University of Medical Sciences, Arabi Ave.,Daneshjoo Blvd, Velenjak, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
zarghi@sbmu.ac.ir
Web page address
https://research.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
Mostafa Alavi-Moghaddam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Clinical Research Development Center-Imam Hossein Hospital, Shahid Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Fax
+98 21 7754 3634
Email
mosalavi@sbmu.ac.ir
Web page address
https://ehcrdc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alavi-Moghaddam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Clinical Research Development Center-Imam Hossein Hospital, Shahid Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Fax
+98 21 7754 3634
Email
mosalavi@sbmu.ac.ir
Web page address
https://ehcrdc.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alavi-Moghaddam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Clinical Research Development Center-Imam Hossein Hospital, Shahid Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Fax
+98 21 7754 3634
Email
mosalavi@sbmu.ac.ir
Web page address
https://ehcrdc.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available