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CTRI Number  CTRI/2020/06/026192 [Registered on: 28/06/2020] Trial Registered Prospectively
Last Modified On: 16/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The study of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation  
Scientific Title of Study   A randomised, double-blind, placebo-controlled, phase 2 trial investigating the safety and efficacy of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation 
Trial Acronym  The ATTRACT Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
2020-001502-38  EudraCT 
VP-C21-006 Version 1.0 dated 24-Apr-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kartikeya Parmar 
Designation  Assistant Professor 
Affiliation  Civil Hospital and B J Medical College 
Address  Department of Medicine Civil Hospital and B J Medical College, Asarwa, Ahmedabad
Gujarat India
Ahmadabad
GUJARAT
380016
India 
Phone  9924643799  
Fax    
Email  drkartik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ranjan Ranjesh 
Designation  Clinical Project Manager 
Affiliation  QED Clinical Services India Private Limited 
Address  Clinical Operations QED Clinical Services India Private Limited, Office number B-209, Westgate Besides YMCA Club
S. G. Highway Ahmedabad, Gujarat India
Ahmadabad
GUJARAT
380015
India 
Phone  8106656954  
Fax    
Email  rranjesh@orphan-reach.com  
 
Details of Contact Person
Public Query  
Name  Mr Gajendrasinh Chanchu 
Designation  Associate Director 
Affiliation  QED Clinical Services India Private Limited 
Address  Clinical and Data Operations QED Clinical Services India Private Limited, Office no B-209, Westgate Besides YMCA Club
S. G. Highway Ahmedabad, Gujarat India
Ahmadabad
GUJARAT
380015
India 
Phone  8511048026  
Fax    
Email  gchanchu@orphan-reach.com  
 
Source of Monetary or Material Support  
Vicore Pharma AB Kronhusgatan 11 SE-411 05 Göteborg Sweden 
 
Primary Sponsor  
Name  Vicore Pharma AB 
Address  Kronhusgatan 11, SE-411 05 Göteborg, Sweden 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
QED Clinical Services India Private Limited  B-209, Westgate, Besides YMCA Club, S. G. Highway, Ahmedabad, Gujarat India 380015. 
 
Countries of Recruitment     India
Russian Federation
Ukraine
United Kingdom  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kartikeya Parmar   Civil Hospital and B J Medical College  Medicine Department Civil Hospital and B J Medical College Asarwa Ahmedabad
Ahmadabad
GUJARAT 		 9924643799

drkartik@gmail.com 
Dr Atul Rajkondawar  Government Medical College and Hospital  Department of Medicine, Government Medical College and Hospital, Hanuman Nagar, Ajni Rd, Medical Chowk,Ajni, Nagpur
Nagpur
MAHARASHTRA 		 9373215775

atul.rajkondawar@gmail.com 
Dr Kapil Zirpe  Grant Medical Foundation Ruby Hall Clinic   Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic , 40, Sasoon Rd, Sangamvadi, Pune, Maharashtra India 411001
Pune
MAHARASHTRA 		 9822844212

kapilzirpe@gmail.com 
Dr Chirag Chhatwani  Metas Adventist Hospital   Infectious Disease, Metas Adventist Hospital, 13-B, Ninth No 0363 to 0365, RS No 21, Opp. Chowpati Main Road, Athwalines City Surat Gujarat 395001
Surat
GUJARAT 		 9979530073

drchiragmchhatwani@gmail.com 
Dr Reema Kashiva  Noble Hospitals Pvt. Ltd   Department of Medicine, Noble Hospitals Pvt. Ltd, 153,Magarpatta City Road, Hadapsar,Pune
Pune
MAHARASHTRA 		 9922618286

reemakashiva@gmail.com 
Dr Nirav Bhalani  Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt Ltd  Medicine Department Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt Ltd Near Siddharth Bunglows, Sama-Savli Road, Vadodara Gujarat lndia 390022
Vadodara
GUJARAT 		 8128995863
-
trial@rhythmheart.com 
Dr Deepak Giri  Rising Medicare Hospital  General Medicine Rising Medicare Hospital Behind Hotel Radission Blu,Kharadi Bypass Road, Kharadi Pune-Maharashtra India 411014
Pune
MAHARASHTRA 		 8446324917
-
ridethegame28287@gmail.com 
Dr Paritosh Baghel   S.L. Raheja Hospital (A Fortis Associate Hospital)  Internal Medicine S.L. Raheja Hospital Raheja Rugnalaya Marg, Mahim (W), Mumbai
Mumbai
MAHARASHTRA 		 9869101772

paritoshbaghel@yahoo.co.in 
Dr Ambuj Garg   Sir Ganga Ram Hospital   Department Of medicine, Sir Ganga Ram Hospital , Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi 110060, India
Central
DELHI 		 9810092313

dr.ambuj@yahoo.com 
Dr Mahesh Sutariya  Unity Trauma Center and ICU (Unity Hospital)  Critical Care Medicine Unity Trauma Center and ICU (Unity Hospital) Nr. D.R. World, Opp Raghuvir Business Empire, Aai Mata Rd, Parvat Patiya,Surat ,Gujarat India 395010
Surat
GUJARAT 		 9979530073
-
sutariyadrmahesh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee Metas Adventist Hospital  Approved 
Institutional Ethics Committee S.L. Raheja Hospital (A FORTIS ASSOCIATE)  Approved 
Institutional Ethics Committee,GMC,Nagpur Government Medical College and Hospital  Approved 
Noble Hospital Institutional Ethics Committee, Noble Hospitals Pvt. Ltd  Approved 
Poona Medical Research Foundation, Ruby Hall Clinic  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
SIDDHI HOSPITAL LAPROSCOPY AND IEC  Approved 
Sir Gangaram Hospital Ethics Committee  Not Applicable 
The Institutional Ethics Committee B.J. Medical College and Civil Hospital  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 
Intervention  C21  IMP will be administered twice daily orally for 7 days from Visit 2 to Visit 8 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting 2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP. 
Comparator Agent  Placebo  IMP will be administered twice daily orally for 7 days from visit 2 to visit 8 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting 2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure.
2) Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test less than 4 days before Visit 1 with signs of an acute respiratory infection.
3) Age more than equal to 18 and less than equal to 70 years.
4) CRP more than 50 and less than 150 mg/l.
5) Admitted to a hospital or controlled facility (home quarantine is not sufficient)
6) In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol. 
 
ExclusionCriteria 
Details  1) Any previous experimental treatment for COVID-19
2) Need for mechanical invasive or non-invasive ventilation
3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis
4) Participation in any other interventional trial within 3 months prior to Visit 1
5) Any of the following findings at Visit 1:
a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab)
b Positive pregnancy test (see Section 8.2.3).
6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial
8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
9) Treatment with any of the medications listed below within 1 week prior to Visit 1:
a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John’s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates)
b. Warfarin
10) Pregnant or breast-feeding female subjects
11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1
12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1
13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder). 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).   The primary endpoint will be the change in CRP from baseline to the average of the last 2 assessments during the treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change from baseline in:
a. Body temperature
b. IL-6
c IL-10
d. TNF
e. CA125
f. Ferritin
2) Number of subjects not in need of oxygen supply
3) Number of subjects not in need of mechanical invasive or non-invasive ventilation
4) Time to need of mechanical invasive or non-invasive ventilation
5) Time on oxygen supply (for those not needing mechanical invasive or non-invasive ventilation)
6) Adverse events 		 Secondary (continuous) endpoints such as body temperature and pre-specified laboratory values and biomarkers will be summarised by visit and for the change over trial by descriptive statistics.
The change from baseline will be compared using similar ANCOVA models as the primary endpoint. 
Exploratory Endpoint:
Blood samples will be stored for potential future analyses of biomarkers reflecting inflammation and lung injury. 		 Biomarker data will be exploratory and the analyses data-driven. Collected data will be visualised graphically and summarised descriptively  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   13/07/2020 
Date of Study Completion (India) 30/09/2020 
Date of First Enrollment (Global)  06/07/2020 
Date of Study Completion (Global) 30/09/2020 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
A randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of C21 200 mg daily dose (100 mg b.i.d) on top of standard of care for 7 days. Approximately 100 subjects with COVID-19 infection will be randomised 1:1 to receive either standard of care and C21 (50 participants) or standard of care and placebo (50 participants). All subjects will be followed-up 7-10 days after receiving the last investigational medicinal product (IMP) dose (visit or phone call, if recovering at home). The primary objective is to investigate the efficacy of C21 200 mg daily dose (100 mg b.i.d.) on COVID-19 infection not requiring mechanical invasive or non-invasive ventilation.
Rationale for trial:
There is no cure or effective specific therapeutics for treating patients with COVID-19. A 51% mortality has been reported in the UK for patients in critical care (ICNARC 2020). The standard of care is primarily focussed on organ support such as respiratory failure. A safe and effective treatment is urgently needed to reduce mortality and improve clinical disease outcome such as from ARDS which is thought to manifest from the exuberant cytokine storm associated with the adaptive stage of the disease. The current clinical trial is the first investigation of C21 in patients infected with COVID-19. Data from the trial will guide and support the design of further clinical investigations of C21 in this indication.
 
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