CTRI/2021/01/030263 [Registered on: 05/01/2021] Trial Registered Prospectively
Last Modified On:
15/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
To study the effect of LYFAQUINâ„¢ (Centhaquine citrate) in hypovolemic shock patients.
Scientific Title of Study
A prospective, multi-centric, open-labeled, phase-IV study to assess safety and efficacy of LYFAQUINâ„¢ (Centhaquine citrate) as a resuscitative agent for hypovolemic shock to be used as an adjuvant to standard treatment of shock.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
PMZ-2010/CT-4.1/2019, Version No 1.0, Dated 16 October 2019
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 Manish S Lavhale
Designation
Director Research and Development
Affiliation
Pharmazz India Pvt. Ltd.
Address
H-6, Site-C,
Surajpur Industrial Area Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201307 India
Phone
9873847397
Fax
Email
manish.lavhale@pharmazz.com
Details of Contact Person Public Query
Name
Mr Sunil Gulati
Designation
Chief Operating Officer
Affiliation
Pharmazz India Pvt. Ltd.
Address
H-6, Site-C, Surajpur Industrial Area Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201307 India
Phone
9811406340
Fax
Email
sunil.gulati@pharmazz.com
Source of Monetary or Material Support
Pharmazz India Private Limited, H-6, Site-C, Surajpur Industrial Area, Greater Noida UP 201307
Primary Sponsor
Name
Pharmazz India Private Limited
Address
H-6, Site-C, Surajpur Industrial Area, Greater Noida UP 201307
AC Subba Reddy Government Medical College & Hospital,Nellore
C Subba Reddy Government Medical College & Hospital, Opp. AC Stadium, Dargamitta, GT Road, Nellore-524007, Andhra Pradesh, India Nellore ANDHRA PRADESH
7981942479
mddbnoal@gmail.com
Dr Pugazhenthan T
All India Institute of Medical Sciences -Raipur
Department of Pharmacology, AIIMS-Raipur, Tatibandh, G. E. Road, Raipur – 492099 Raipur CHHATTISGARH
9486279090
drpugal23@gmail.com
Dr Aman Khanna
Aman Hospital and Research Center
15 Shashwat, Opp ESI Hospital, Gotri Road, Vadodara-390021 Vadodara GUJARAT
9904402122
amankhanna1974@gmail.com
Dr Hardik Parmar
Anjna Hospital and Clinisearch Pvt. Ltd
7-8-9, Urban Ville, Near Vadodara Cricket Academy,
Opp. Turf 106, Priya Talkies, Sevasi Link Road,
Vadodara, Gujarat – 391101, India
Ahmadabad GUJARAT
9909012706
hardikr2p@yahoo.com
Dr Mahesh KM
Bangalore Medical College and Research Institute , Victoria Hospital, bagalore
Department of Anesthesiology and Critical care,Victoria Hospital, Mysore Road,
Near City Market,New Tharagupet,
Bengaluru-560002
Bangalore KARNATAKA
9986112661
drmaheshmysore@gmail.com
Dr Parvez David Haque
Christian Medical College and Hospital
Department of General Surgery,Room No-1138, First Floor,Brown Road, Ludhiana-141008 Ludhiana PUNJAB
9872630178
pdhaque@gmail.com
Dr Dinesh Jain
Dayanand Medical College & Hospital
Department of Medicine, Civil Lines, Tagore Nagar, Ludhiana-141001, Ludhiana PUNJAB
9815532533
drjaindinesh@yahoo.co.in
Dr Manoj Saluja
Government Medical College and Attached Hospitals
Department of Medicine, Rangbari Road, Kota, Rajasthan – 324005, India Kota RAJASTHAN
9829183813
salujamanoj2000@yahoo.com
Dr Richa Giri
GSVM Medical College
Post Graduate Department of Medicine,
GSVM Medical College, Swaroop Nagar,
Kanpur-208002. UP. India
Kanpur Nagar UTTAR PRADESH
8400331045
krricha227@gmail.com
Dr Rajat Choudhuri
Institute of Post Graduate Medical Education & Research and SSKM Hospital
Associate Professor,Department of Anaesthesiology,Main Block, 2nd Floor,ITU 244 A.J.C. Bose Road Kolkata-700020 Kolkata WEST BENGAL
Jawahar Lal Nehru Medical College and Attached Hospitals
Kala Bagh Ajmer-305001 Rajasthan Ajmer RAJASTHAN
9460479888
doctor.sanjiv@gmail.com
Dr Karthikeyan Natarajan
KG Hospital and Post Graduate Medical Institute and Research Centre
Door No-5, Government Arts College Road, Coimbatore-641018,
Tamil Nadu., India
Coimbatore TAMIL NADU
8754404051
plb.karthik@gmail.com
Dr Sameer Haveri
KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre
Department of Orthopaedics, Ground Floor, O.P.D. No.: 2, Nehru Nagar Belgauvi Belgaum KARNATAKA
09844333082
drsameerhaveri@gmail.com
Dr Anshul Jain
Maharani Laxmi Bai Medical College and Associated Hospital
Department of Anesthesia, Kanpur Road, Jhansi-284128, Uttar Pradesh, India Jhansi UTTAR PRADESH
7054057995
dranshuljain81@gmail.com
Dr Sanjay Kumar
Medicity Hospital (A Unit of V3 Healthcare Private Limited),
Department of Medicine,
Teen Pani,Kichha Road,Udham Singh Nagar,
Rudrapur-263153,
Uttarakhand
Udham Singh Nagar UTTARANCHAL
9868080947
drsanjaymamc007@zoho.com
Dr Ajay Bulle
Meditrina Institute of Medical Sciences,
278, Central Bazar Road, Ramdaspeth, Nagpur-440010, India Nagpur MAHARASHTRA
9921981109
ajaybulle@yahoo.com
Dr Nilesh Radheshyam Agrawal
New Era Hospital & Research Institute
Queta Colony, Near
Telephone Exchange
Square, Central Avenue
Road, Nagpur- 440008 Nagpur MAHARASHTRA
8888667808
anileshr@gmail.com
Dr Deo Nidhi Mishra
Nirmal Hospital
Devalya, Department of Medicine, Opp. Gate No. -3, M.L.B. Medical College, Jhansi - 284128, Jhansi UTTAR PRADESH
9415031689
drmishra.nirmal@gmail.com
Dr Anil Kumar Sharma
Pushpanjali Hospital & Research Centre Pvt. Ltd
Department of Orthopedics, Ground Floor,
Pushpanjali Hospital &
Research Centre Pvt.
Ltd., Pushpanjali
Palace, Delhi Gate,
Agra-282002 Agra UTTAR PRADESH
8357077174
shroti.anil@gmail.com
Dr Prashant Rahate
Seven Star Hospital
Jagnade Square, KDK College Road-440009 Nagpur MAHARASHTRA
Institute Ethics Committee, All India Institute of Medical Sciences- Raipur Room no. 2103, 2nd Floor South Wing Medical College Complex, Gate No. 5 All India Institute of Medical Sciences, Tatibandh, GE Road, Raipur, 492099, Chhattisgarh, India
Drug Trial Ethics Committee (DTEC), Dayanand Medical College & Hospital, Civil Lines, Ludhiana -141001 (Punjab)
Approved
ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR GSVM MEDICAL COLLEGE KANPUR SWAROOP NAGAR SWAROOP NAGAR KANPUR Kanpur Nagar Uttar Pradesh - 208002 India
Approved
Ethics Committee of BMCRI Bangalore, Medical College and Research Institute, Fort K R Road Bengaluru (Bangalore) Urban Karnataka - 560002, India
Approved
Ethics Committee, M.L.B Medical College and Associated Hospital, Kanpur Road, Jhansi – 284128, Uttar Pradesh, India
Approved
Ethics Committee, New Era Hospital, Central Avenue Road, Near Telephone Exchange Chowk, Queta Colony, Near Jalaram Mandir, Nagpur-440008
Approved
Ethics Committee, Rahate Surgical Hospital, 517, Kolba Swami Square, Old Mangalwari, Central Avenue Road, Nagpur-440008, Maharashtra
Approved
Institutional Ethics Committee KG Hospital K. Govindaswamy Naidu Medical Trust, No. 5, Government Arts College Road, Coimbatore, Tamil Nadu - 641018 India
Approved
Institutional Ethics Committee Aman Hospital and Research Centre 15 Shashwat, Opp, E.S.I Hospital Sarabhai, Gotri Road Vadodara Gujarat - 390021 India
Approved
Institutional Ethics Committee, AC Subba Reddy Government Medical College & Hospital, Opp. AC Stadium, Dargamitta, GT Road, Nellore-524007, Andhra Pradesh, India
Approved
Institutional Ethics Committee, Aman Hospital and Research Centre, 15 Shashwat, Opp, E.S. I Hospital Sarabhai, Gotri Road, Vadodara, Gujarat-390021
Approved
Institutional Ethics Committee, Christian Medical College and Hospital, Brown Road ,Ludhiana-141008
Approved
Institutional Ethics Committee, GMC, Kota, Government Medical College and Attached Hospitals, Rangbari Road, Kota, Rajasthan – 324005, India
Approved
Institutional Ethics Committee, Jawahar Lal Nehru Medical College Kala Bagh,Ajmer,Rajasthan-305001
Approved
Institutional Ethics Committee, Nirmal Hospital, Opp. Gate No. -3, M.L.B. Medical College, Jhansi - 284128, Uttar Pradesh, India
Approved
Institutional Ethics Committee, SGRDIMSAR, Sri Guru Ram Das Institute of Medical Science and Research,VPO Vallah,Metha Road ,Amritsar ,Punjab
IPGMER Research Oversight Committee, Institute of Post Graduate Medical Education and Research
Approved
Janta Hospital Ethics Committee, Janta Hospital and Maternity Center, Servey Number 374, Amara-Akhari Bypass, Chunar Road, Varanasi-221011, Uttar Pradesh, India
Approved
Meditrina Institute Ethics Committee Meditrina Institute of Medical Sciences 278, Central Bazar Road Ramdaspeth Nagpur Nagpur Maharashtra - 440010 India
Approved
Pushpanjali Hospital Ethics Committee, Pushpanjali Hospital & Research Center Pvt. ltd, Pushpanjali Palace, Delhi Gate, Agra -282002 U.P.
Lyfaquin (Dose: 0.01 mg/kg) + Standard of care: Lyfaquin will be administered intravenously after enrolment in study to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard Shock Treatment.
First dose of LYFAQUINâ„¢ (0.01 mg/kg) will be administered as an intravenous infusion over 1 hour in 100 mL of normal saline. Second dose of LYFAQUINâ„¢ will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of previous dose and total doses per day (in 24 hours) will not exceed 3 doses. LYFAQUINâ„¢ administration if needed will continue for two days post enrollment. Minimum 1 dose or maximum 6 doses of LYFAQUINâ„¢ will be administered within first 48 hours post enrollment
Comparator Agent
NOT APPLICABLE
NOT APPLICABLE
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Adult males or females aged 18 years or older.
2. Patients with hypovolemic shock admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the patients shall be the one used in each hospital setup.
3. Blood Lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
ExclusionCriteria
Details
1. Development of any other terminal illness not associated with hypovolemic shock during study duration.
2. Patient with altered consciousness not due to hypovolemic shock and comatose patient.
3. Known pregnancy.
4. Cardiopulmonary resuscitation (CPR) before enrollment.
5. Presence of a do not resuscitate order.
6. Patient is participating in another interventional study.
7. Patients with systemic diseases which were already present before having trauma, such as: sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS. Decision to be made by the investigator.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment
Secondary Outcome
Outcome
TimePoints
Systolic and diastolic blood pressure; Mean through 48 hours and at the time of discharge or day 7.
first 48 hours and at the time of discharge or day 7
Base-deficit; Mean through 48 hours
first 48 hours
Time in intensive care unit (ICU)
At the time of discharge or day 7
Time on ventilator
at the time of discharge or day 7
Change in blood lactate, Mean through 48 hours
first 48 hours
Urine output during the first 48 hours
first 48 hours
Incidence of mortality
at the time of discharge or day
Multiple Organ Dysfunction Syndrome score (MODS); Mean through day 7 or at the time of discharge
At the time of discharge or day 7
Acute Respiratory Distress Syndrome (ARDS); Mean through day 7 or at the time of discharge
At the time of discharge or day 7
Glasgow Coma Scale (GCS); Mean through day 7 or at the time of discharge
At the time of discharge or day 7
Target Sample Size
Total Sample Size="400" Sample Size from India="400" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This prospective, multi-centric, open-labeled, Phase-IV study to assess safety and efficacy of LYFAQUINTM(Centhaquine Citrate) as a resuscitative agent for hypovolemic shock to be used as an adjuvant to standard treatment of shock.
This study is designed to collect post-authorization safety data of LYFAQUINTM (Centhaquine Citrate), a novel first-in-class drug to treat life-threatening condition of hypovolemic shock with unmet need.
Results of clinical phase II and phase III studies indicate that, LYFAQUINâ„¢ (Centhaquine citrate) is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. Phase II results demonstrate highly significant efficacy in improving blood pressure (p<0.0001), lactate levels (p=0.0012) and base-deficit (p<0.0001). There was also an improvement in reduction in use of vasopressors and reduced mortality. Similarly, results of phase III study confirmed the safety and efficacy of LYFAQUINTM as an adjuvant to standard of care for hypovolemic shock. Therefore, to assess safety of LYFAQUINTM in large population a phase IV study (post-authorization safety study) has been designed.
Sample size: for this single arm study is total of 400 patients will be enrolled in the study.
The enrolment period of the study will be approximately 12 months and total duration of the study will be approximately 15 months. For an individual patient, duration of the study will be from his/her enrolment to time of discharge or 7 days (whichever is earlier). Visit 1/day 1 (screening/enrollment baseline/treatment visit) and follow patient till discharge or day 7 (end of study) whichever is earlier.
Treatment Arm: LYFAQUINTM(Dose: 0.01 mg/kg) + Standard of care
All patients will be provided the standard of care along with the study drug LYFAQUINTM. LYFAQUINTMwill be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment.
Dossing:
LYFAQUINTM will be administered at a dose of 0.01 mg/kg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of LYFAQUINTM will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of previous dose and total doses per day (in 24 hours) will not exceed 3 doses. LYFAQUINTM administration if needed will continue for two days post enrollment. Minimum 1 dose or maximum 6 doses of LYFAQUINTM will be administered within first 48 hours post enrollment. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment. Each patient will be assessed for safety and efficacy parameters as per study schedule.