| CTRI Number |
CTRI/2020/10/028423 [Registered on: 15/10/2020] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| 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 clinical study to see the effects and safety of PNB-001 in patients with moderate COVID-19 infection |
|
Scientific Title of Study
|
A Randomized, Open label Clinical Study to Evaluate Efficacy and Safety of PNB-001 in Patients with moderate COVID-19 Infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-PNB-001 version 4.0 dated 02 Sep 2020 |
Protocol Number |
| CT/ND/95/2020 |
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 |
91-22-41006794 |
| 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
MAHARASHTRA
400607
India |
| Phone |
91-22-41006794 |
| 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 Pvt Ltd |
Office No. 02, 03 & 04, Second Floor,
Highland Corporate Center,
Kapurbawdi Junction, Thane (W) 400 607,
Maharashtra, India
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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,
Maharashtra, India.
Pune
MAHARASHTRA |
91-8806664773
dr.pradnyabhalerao@gmail.com |
| Dr Shashi Bhushan B L |
Victoria Hospital Bangalore Medical College and Research Institute |
Department of
Pulmonology, B Block
Ground Floor, Victoria
Hospital, Bangalore
Medical College and
Research Institute, Fort,
K R Road, Bangalore
Urban, Karnataka -
560002, India
Bangalore
KARNATAKA |
91-9448239644
shashibhushanbl@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, Bangalore Medical College and Research Institute |
Approved |
| Institutional Ethics Committe of B.J .Govt.Medical College And Sassoon General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW |
PNB-001 100 mg capsule three times a day with standard of care treatment for 14 days |
| Comparator Agent |
Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW |
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 2 days of randomization.
3. Patients havingPneumonia with no signs of severe disease with SpO2 ≤94% (range 90-94%) on room air.
4. Patients with any two of the following signs or symptoms suggestive of COVID-19.
- Fever
- Cough
- dyspnoea or hypoxia
- Respiratory rate more or equal to 24 per minute.
5. Radiographic infiltrates as confirmed by imaging (chest xray).
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 subjects 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. Known allergies, hypersensitivity, or intolerance to investigational product or its excipients.
3. Patients with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
4. Patients with abnormal Sr.Creatinine value of ≥ 2 mg/dl at screening visit.
5. Patients with Type 1 diabetes mellitus.
6. Patients with uncontrolled Type 2 diabetes mellitus with random sugar ≥ 200 mg/dL.
7. Uncontrolled hypertension (systolic blood pressure> 160mmHg, or diastolic blood pressure>100mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
8. 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.
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) (DSMV) 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.Mean change in the ordinal scale from baseline.
2.Mortality Rate by Day 28 |
15 Days
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of patients showing change in clinical status using the ordinal scale from baseline.
2.Percent of patients showing improvement in inflammatory segments in X-ray chest from baseline.
3.Reduction of Days of hospitalization.
4.Duration of supplemental oxygen (if applicable).
5.Improvement in oxygen saturation from baseline.
6.Days to negative PCR for Covid19.
7.Change in (IL6, CRP) inflammatory markers from baseline |
15 Days |
| The assessment of safety will be based on the frequency of Adverse Events and changes in laboratory values. All safety variables will be summarized using descriptive statistics |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/10/2020 |
| Date of Study Completion (India) |
18/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is a A Randomized, Open label Clinical Study to Evaluate Efficacy and Safety of PNB-001 In Patients with moderate COVID-19 Infection in 40 patients in 1:1 ratio. The Primary Endpoints are Mean change in the ordinal scale from baseline. Mortality Rate by Day 28 The Secondary Endpoints are Percentage of patients showing change in clinical status using the ordinal scale from baseline. Percent of patients showing improvement in inflammatory segments in X-ray chest from baseline. Reduction of Days of hospitalization. Duration of supplemental oxygen (if applicable). Improvement in oxygen saturation from baseline. Days to negative PCR for Covid19. Change in (IL6, CRP) inflammatory markers from baseline |