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CTRI Number  CTRI/2021/04/032791 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 08/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Assess Efficacy and Safety of Inhaled Interferon-Beta Therapy for COVID-19 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalized due to moderate COVID-19 
Trial Acronym  SPRINTER 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2020-004743-83  EudraCT 
NCT04732949  ClinicalTrials.gov 
PIND# 152507  Other 
SG018, Version 5.0 dated 09-Sep-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Annappa Kamath 
Designation  Senior Solutions Consultant Director 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  CRS Solution Consultants Department
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village
Bangalore
KARNATAKA
560103
India 
Phone  918067169360  
Fax  918067723001  
Email  Annappa.Kamath@PAREXEL.com  
 
Details of Contact Person
Public Query  
Name  Dr Annappa Kamath 
Designation  Senior Solutions Consultant Director 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  CRS Solution Consultants Department
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village
Bangalore
KARNATAKA
560103
India 
Phone  918067169360  
Fax  918067723001  
Email  Annappa.Kamath@PAREXEL.com  
 
Source of Monetary or Material Support  
Synairgen Research Ltd, Mailpoint 810, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, United Kingdom. 
 
Primary Sponsor  
Name  Synairgen Research Ltd 
Address  Mailpoint 810, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, United Kingdom 
Type of Sponsor  Other [Pharmaceutical Industry] 
 
Details of Secondary Sponsor  
Name  Address 
PAREXEL International Clinical Research Private Limited  CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA 
 
Countries of Recruitment     Argentina
Belgium
Brazil
Colombia
France
Germany
India
Israel
Italy
Mexico
Netherlands
Portugal
Romania
Serbia
Spain
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Kumar  Acharya Vinoba Bhave Rural Hospital  Datta Meghe Institute Of Medical Sciences,Sawangi
Wardha
MAHARASHTRA 		 9850393787

sunilkumararmed@gmail.com 
Dr Anita Mathew  Fortis Hospitals Limited  Level 5, Clinical research department, Mulund Goregaon Link Road, Bhandup (W),400078
Mumbai
MAHARASHTRA 		 2249254821

jojosanish@gmail.com 
Dr Milind Suryakantrao vyawahare  Government Medical College and Hospital  Department of medicine, near hanuman nagar, Medical Square,
Nagpur
MAHARASHTRA 		 9822234566
9822234566
drmilind72@gmail.com 
Dr Jayaraju BS  JSS Hospital  Department of Respiratory Medicine, Mahatma Gandhi road, 570004
Mysore
KARNATAKA 		 9845115936

drjayarajbs@yahoo.com 
Dr Yandrapati Gnana Sundara Raj  King George Hospital  Clinical Research Room, Department of General Medicine, Rajendraprasad Ward, Maharanipeta-530002
Visakhapatnam
ANDHRA PRADESH 		 08912782211
08912782211
drysundarrajuresearch@gmail.com 
Dr Ashwin Kulkarni  M S Ramaiah Medical College  Department of Medicine Ramaiah Medical College, MSRIT Post,560054
Bangalore
KARNATAKA 		 08023602983
08023601983
drashwinkulkarni@yahoo.com 
Dr Arunansu Talukdar  Medical College and Hospital, Kolkata  Department of Medicine, 88, College Street, 700073
Kolkata
WEST BENGAL 		 9831222514

dratalukdar@gmail.com 
Dr Ashish Shankarrao Deshmukh  ORIION Citicare Super Specialty Hospital  5-5-70, opposite Kalash Mangal Karyalaya, Osmanpura,431005
Aurangabad
MAHARASHTRA 		 7972087583

drdeshmukhas@gmail.com 
Dr Ashish Bhalla  Postgraduate Institute of Medical Education and Research  Department of Internal Medicine, Sector-12, 160012, India
Chandigarh
CHANDIGARH 		 91172230109

bhalla.chd@gmail.com 
Dr Nirav Bhalani  Rhythm Heart Institute- A unit of SLPL  1st Floor, Clinical Research Department, Near Siddharth Bunglows, Sama-Savli Road, 390022
Vadodara
GUJARAT 		 912652541006
912652541006
trial@rhythmheart.com 
Dr Kannan Rajendran  Saveetha Medical College Hospital  CRF-Department, Saveetha Nagar, Thandalam-602 105
Chennai
TAMIL NADU 		 04466726645

endork@yahoo.com 
Dr kailash Jagadish Rathi  Suyog Hospital  2nd floor, B-wing, Krushi utpanna Bazar samiti sankul, Panchavati
Nashik
MAHARASHTRA 		 9422254748

drkrathi@gmail.com 
Dr Dipak Prafullbhai Viradia  Unity Hospital  Unity trauma center and ICU, department of Chest medicine, Near D. R. World, Opp Raghuvir Business Empire, Aai mata Rd, Parvat patiya
Surat
GUJARAT 		 7405698000
7405698000
drdipakpviradia@gmail.com 
Dr Prabhu Subramani  Victoria Hospital, Bangalore Medical College and Research Institute  Room 301. 3rd Floor, OPD Block, K.R.Road, Fort - 560002
Bangalore
KARNATAKA 		 91-9980296340
918026706260
drprabhusubramani@gmail.com 
Dr Namdev Sakharam Jagtap  Vishwaraj Superspeciality Hospital  Department of Medicine, Ground floor, OPD no 1 , Pune Solapur Road ,Near Loni railway station , Kadamwasti, 412201
Pune
MAHARASHTRA 		 9823171553
912024395153
drjagtapdev@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethics Committee Maeer’s VishwaRaj Hospital  Approved 
Ethics committee of Bangalore Medical College and Research Institute  Approved 
Ethics Committee, M.S.Ramaiah Medical College and Hospitals  Approved 
Institutional Ethics Committee Postgraduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee, Datta Megha Institute of Medical Sciences   Approved 
Institutional Ethics Committee, Fortis Hospitals Limited   Approved 
Institutional Ethics committee, JSS Medical College  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional ethics committee, Medical College and Hospital, Kolkata  Approved 
Institutional Ethics Committee, Nagpur  Approved 
Oriion Citicare Hospital- Institutional Ethics Committee  Approved 
Rhythm Heart Institute Ethics Committee   Approved 
Saveetha Medical College and Hospital – Institutional Ethics Committee (SMCH-IEC)  Approved 
Suyog Hospital Institutional Ethics Committee  Approved 
Unity Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution. Patients will inhale study medication once a day for 14 days 
Intervention  SNG001  SNG001 nebuliser solution, 2 syringes each containing 0.65 mL. Patients will inhale study medication once a day for 14 days 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Admitted to hospital due to the severity of their COVID-19

2) Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection

3) Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)

4) Provided informed consent

5) Female patients must be greater than or equals to 1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception

6) Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-beta (IFN-beta 1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-beta1a/matching placebo to prevent pregnancy

7) Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women less than 50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women greater than or equals to 50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enroll a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent 
 
ExclusionCriteria 
Details  1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay

2) Non-invasive ventilation (CPAP/BiPAP) or high-flow nasal oxygen - therapy (WHO OSCI score of 5)

3) Endotracheal intubation and invasive mechanical ventilation (HO OSCI score of ≥6)) or admission to intensive care

4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay

5) Any condition, including findings in the patients medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation

6) Participation in previous clinical trials of SNG001

7) Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

8) Inability to use a nebuliser with a mouthpiece

9) Inability to comply with the requirements for storage conditions of study medication in the home setting

10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation

11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to hospital discharge
Time to recovery 		 Day 1 until Day 28
Day 1 until Day 28 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Progression to severe disease or death  Day 1 until Day 35 
Progression to intubation or death  Day 1 until Day 35 
Death within 35 days of first dose  Day 1 until Day 35 
Recovery as analysed at Days 7, 14, 21 and 28   Days 7, 14, 21 and 28 
Hospital discharge by days 7, 14, 21 and 28  Days 7, 14, 21 and 28 
Number of patients with improvement based on entire WHO OSCI score by days 7, 14, 21 and 28  Days 7, 14, 21 and 28 
Change in total score according to the breathlessness, cough and sputum scale (BCSS) and disaggregated breathlessness and cough scores  Day 1 until Day 28 and then on Day 60 and Day 90  
Changes in National Early Warning Score (NEWS2) during the hospitalisation period  Day 1 until Day 28  
Number of patients with presence of COVID-19 symptoms based on daily assessment  Day 1 until Day 28 
Number of patients with limitations of usual activities based on daily assessment  Day 1 until Day 28 
Quality of life measured using EuroQol 5-dimension 5-level (EQ-5D-5L)  Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90; Day 1 until Day 35 (mobility, self care and usual activities dimension) 
Number of patients with long-COVID-19 symptoms based on General Anxiety Disorder 7 Questionnaire (GAD-7)  Day 15, Day 28, Day 60 and Day 90 
Number of patients with long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4)  Day 15, Day 28, Day 60 and Day 90 
Number of patients with long-COVID-19 symptoms based on Patient Health Questionnaire-9 (PHQ-9)  Day 15, Day 28, Day 60 and Day 90 
Number of patients with long-COVID-19 symptoms based on Brief Pain Inventory (Short Form)  Day 15, Day 28, Day 60 and Day 90 
Safety and tolerability vital signs, AEs concomitant medications, and immunogenicity  Day 1 until Day 28 
 
Target Sample Size   Total Sample Size="610"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "623"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/06/2021 
Date of Study Completion (India) 10/02/2022 
Date of First Enrollment (Global)  12/01/2021 
Date of Study Completion (Global) 10/02/2022 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalized patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

 
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