CTRI/2021/09/036411 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On:
20/02/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Phase III Clinical Study to Evaluate the Effect of PNB-001 in Treatment of Patients with Moderate COVID-19 Infection
Scientific Title of Study
A Phase III, Randomized, Open Label, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of PNB-001 as an Adjunct to Standard of Care Compared to Standard of Care Alone in Treatment of Patients with Moderate COVID-19 Infection
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BCR-PNB-002 Version 1.0 dated 13 May 2021
Protocol Number
CT-06-CT/ND/85/2021
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pradnya Bhalerao
Designation
Principal Investigator
Affiliation
B J Govt. Medical College and Sassoon General Hospital
Address
Department of Anaesthesiology, 1st floor, Block 11, B J Govt.
Medical College and Sassoon General Hospital, Jai Prakash
Narayan Road, Near Pune Railway Station, Pune , Maharashtra,
India.
Pune MAHARASHTRA 411001 India
Phone
91-8806664773
Fax
Email
dr.pradnyabhalerao@gmail.com
Details of Contact Person Scientific Query
Name
Dr Neeta Nargundkar
Designation
Managing Director
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,
Kapurbawdi Junction, Thane (W),Maharashtra, India
Thane MAHARASHTRA 400607 India
Phone
02241006794
Fax
Email
drneeta@biospherecro.com
Details of Contact Person Public Query
Name
Dr Neeta Nargundkar
Designation
Managing Director
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,
Kapurbawdi Junction, Thane (W),Maharashtra, India
Thane MAHARASHTRA 400607 India
Phone
02241006794
Fax
Email
drneeta@biospherecro.com
Source of Monetary or Material Support
PNB Vesper Life Science Pvt. Ltd,Door No. 40/ 1045G, 5th floor, Amritha Towers, Cochin ,
Kerala 682011, India
Primary Sponsor
Name
PNB Vesper Life Science Pvt Ltd
Address
Door No. 40/ 1045G, 5th floor, Amritha Towers, Cochin , Kerala
682011, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Biosphere Clinical Research PvtLtd
Office No. 02, 03 & 04, Second Floor, Highland
Corporate Center, Kapurbawdi Junction, Thane
(W) 400 607, Maharashtra, India
Department of TB and Respiratory Diseases, J N Medical College and Hospital, AMU, Aligarh-202002, Uttar Pradesh, India. Aligarh UTTAR PRADESH
9412175925
zrin_amu@yahoo.com
Dr Raghavendra S K
Adichunchanagiri Hospital and Research Centre
Department of Clinical Research,
B G Nagara, Nagamangala Taluka, Mandya-571448, Karnataka, India Mandya KARNATAKA
9164592123
nanragakhu@gmail.com
Dr Md Sabah Siddiqui
All India Institute of Medical Sciences Raipur
Department of Medicine, All India Institute of Medical Science (AIIMS) G.E Road Tatibandh Raipur-492099,Chhattisgarh
Raipur CHHATTISGARH
8518881911
dr.sabah@aiimsraipur.edu.in
Dr Pradnya Bhalerao
B J Govt. Medical College and Sassoon General Hospital
Department of
Anaesthesiology, 1st
floor, Block 11, B J
Govt. Medical College
and Sassoon General
Hospital, Jai Prakash
Narayan Road, Near
Pune Railway Station,
Pune -411001 Pune MAHARASHTRA
91-8806664773
dr.pradnyabhalerao@gmail.com
Dr Suninder Singh Arora
Batra Hospital and Medical Research Centre
Room G-15, B-Block, Department of Medicine and Critical Care
Medicine, Batra Hospital and Medical Research Centre, 1 Tughlakabad Institutional Area Mehrauli, Badarpur Road, New Delhi-110062, India. New Delhi DELHI
9810113414 91-1129957661 drssarora@gmail.com
Dr Susenjit Mallick
College of Medicine and Sagore Dutta Hospital
Department of Medicine, College of Medicine & Sagore Dutta Hospital,578, B.T. Road, Kamarhati, Kolkata-700058, West Bengal, India. Kolkata WEST BENGAL
9433746217
dr.susenjit@gmail.com
Dr Shubhangi Deshpande
GMERS Medical College and General Hospital
Department of General Medicine, GMERS Medical College and General Hospital, Gotri, Vadodara-390021, Gujarat, india. Vadodara GUJARAT
7878081208
shubhangi311@yahoo.com
Dr Narsinga Rao
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Medicine, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam, Andhra Pradesh-532001, India. Srikakulam ANDHRA PRADESH
9908611119
drnarasingaraossvv@yahoo.com
Dr Vinay Panchalwar
Government Medical College Nagpur
Department of Medicine, Government Medical College, Medical Square, Hanuman Nagar, Ajni Road, Nagpur-440003, Maharashtra, India. Nagpur MAHARASHTRA
9561564230
vinaypanch@yahoo.com
Dr Ram Sabad Raman
Maharaj Agrasen Hospital
Department of Medicine, Maharaj Agrasen Hospital, West Punjab Bagh, New Delhi-110026, India New Delhi DELHI
9312702643 01125225403 dr.rs.raman.2005@gmail.com
Dr Anand Nikalje
Mahatma Gandhi Mission’s Medical College and Hospital
Department of Pharmacology, Clinical Research Unit, MGM’s Medical College and Hospital, Cidco, N-6, Aurangabad-431003, Maharashtra, India Aurangabad MAHARASHTRA
9822496190
dranandnikalje68@gmail.com
Dr Arunansu Talukdar
Medical College and Hospital Kolkata
Department of Medicine, Medical College and Hospital, 88, College Street, Kolkata-700073, West Bengal, India
Kolkata WEST BENGAL
9831222514
dratalukdar@gmail.com
Dr Pravin Nagulal Soni
PCMC’s PGI Yashwantrao Chavan Memorial Hospital
Room no 03, 2nd floor
Department of Medicine
PCMC’s PGI Yashwantrao Chavan Memorial Hospital, Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra, India Pune MAHARASHTRA
9822057511
drpravinsoni18@gmail.com
Dr Vipul Mishra
Pushpanjali Hospital and Research Centre
Clinical Research Department, Ground Floor, Pushpanjali Hospital and Research Centre Pvt. Ltd., Pushpanjali Plaza, Delhi gate, Agra-282002, Uttar Pradesh, India. Agra UTTAR PRADESH
Institutional Ethics Committee PCMCs PGIYashwantrao Chavan Memorial Hospital
Approved
Institutional Ethics Committee, Adichunchanagiri Hospital & Research Centre
Approved
Institutional Ethics Committee, AIIMS Raipur
Submittted/Under Review
Institutional Ethics Committee, College of Medicine & Sagore Dutta Hospital Kolkata
Approved
Institutional Ethics Committee, GGMC & Sir J J Group of Hospitals Mumbai
Submittted/Under Review
Institutional Ethics Committee, Government Medical College & Government General Hospital, Srikakulam
Approved
Institutional Ethics Committee, J N Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, Pushpanjali Hospital and Research Centre Pvt. Ltd
Submittted/Under Review
Institutional Human Ethics Committee GMERS Medical College and General Hospital
Submittted/Under Review
Mahatma Gandhi Mission’s Ethics Committee for Research on human subjects
Submittted/Under Review
Scientific Research and Ethical Review Committee Batra Hospital and Medical Research Centre
Submittted/Under Review
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
PNB-001 with Standard of care treatment as per the latest clinical management protocol for COVID-19 as issued by Govt of India, MoHFW
PNB-001 100 mg capsule ,orally three times a day with standard of care treatment for 14 days
Comparator Agent
Standard of care treatment as per the latest clinical
management protocol for
COVID-19 as issued by Govt of India, MoHFW
Standard of care treatment for 14 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Male or female patients aged between 18 and 65 years (both Inclusive).
2.Patients with laboratory-confirmed SARS-CoV-2 infection as determined by PCR within 5 days of randomization.
3.Patients having moderate COVID- 19 infection with SpO2: 90% to ≤ 93% on room air or Respiratory rate more than or equal to 24 per minute.
4.Radiographic infiltrates as confirmed by imaging (chest x- ray/CT-scan).
5.Patients who have not received Covid-19 vaccine or received either one or two doses of the vaccine.
6.Patients who are willing to sign written informed consent for participation in the study and willing to adhere to all protocol procedures.
7.Eligible patients of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
ExclusionCriteria
Details
1.Patient requiring invasive mechanical ventilation.
2.Patients with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
3.Patients with abnormal Sr.Creatinine value of ≥ 2 mg/dl at screening visit.
4.Patients with Type 1 diabetes mellitus.
5.Patients with uncontrolled Type 2 diabetes mellitus with random blood sugar level ≥ 350 mg/dL.
6.History or presence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, diseases or metabolic disturbances or other relevant systemic diseases that would preclude the safe administration of the Investigational product.
7.Uncontrolled hypertension (systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
8. History of diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for within 4 weeks with appropriate anti-tuberculosis therapy per local guidelines at screening visit.
9.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
10.History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive or other clinically active liver disease.
11.History of human immunodeficiency virus (HIV) antibody positive.
12.History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM- V) criteria within 1 years before Screening.
13.History of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
14.Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
15.Patient received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study.
16.Pregnant or breast-feeding at screening.
17.Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1.Time to clinical improvement (defined as the time to improvement of two points on a 7-point WHO ordinal scale from baseline till Day15).
2.Mortality Rate by Day 28.
15 Days
28 Days
Secondary Outcome
Outcome
TimePoints
1.Mean change in ordinal scale from baseline till Day 15.
2.Percentage of patients showing improvement in ordinal scale to score one from baseline to Day 15.
3.Percent of patients showing improvement to score in inflammatory segments in X-ray chest from baseline to Day 15.
4.Duration of hospitalization (number of discharges by day 15.
5.Duration of supplemental oxygen (number of patients not needing oxygen support artificially by Day 15).
6.Days to negative PCR for Covid19 by Day 15.
15 Days
Target Sample Size
Total Sample Size="220" Sample Size from India="220" 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
A Study is a Phase III, Randomized, Open Label, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of PNB-001 as an Adjunct to Standard of Care Compared to Standard of Care Alone in Treatment of Patients with Moderate COVID-19 Infection.
Primary Endpoints
Time to clinical improvement (defined as the time to improvement of two points on a 7-point WHO ordinal scale from baseline till Day15).
MortalityRatebyDay28.
Secondary Endpoints
Mean change in ordinal scale from baseline till Day 15.
Percentage of patients showing improvement in ordinal scale to score one from baseline to Day 15.
Percentofpatientsshowingimprovement to score in inflammatorysegmentsinX-raychestfrombaseline to Day 15.
Durationofhospitalization (number of discharges by day 15.
Durationofsupplementaloxygen (number of patients not needing oxygen support artificially by Day 15).