A Phase III Clinical Study to Evaluate the Effect of PNB-001 in Treatment of Patients with Moderate COVID-19 Infection
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/09/036411
- Lead Sponsor
- PNB Vesper Life Science Pvt Ltd
- 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).
Mortality Rate by Day 28.
**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.
Percent of patients showing improvement to score in inflammatory segments in X-ray chest from baseline to Day 15.
Duration of hospitalization (number of discharges by day 15.
Duration of supplemental oxygen (number of patients not needing oxygen support artificially by Day 15).
Days to negative PCR for Covid19 by Day 15.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.Mortality Rate by Day 28. 15 Days | 28 Days 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). 15 Days | 28 Days
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (14)
J N Medical College and Hospital
🇮🇳Aligarh, UTTAR PRADESH, India
Adichunchanagiri Hospital and Research Centre
🇮🇳Mandya, KARNATAKA, India
All India Institute of Medical Sciences Raipur
🇮🇳Raipur, CHHATTISGARH, India
B J Govt. Medical College and Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Batra Hospital and Medical Research Centre
🇮🇳Delhi, DELHI, India
College of Medicine and Sagore Dutta Hospital
🇮🇳Kolkata, WEST BENGAL, India
GMERS Medical College and General Hospital
🇮🇳Vadodara, GUJARAT, India
Government Medical College & Government General Hospital (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Government Medical College Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Maharaj Agrasen Hospital
🇮🇳Delhi, DELHI, India
Scroll for more (4 remaining)J N Medical College and Hospital🇮🇳Aligarh, UTTAR PRADESH, IndiaDr Zuber AhmadPrincipal investigator9412175925zrin_amu@yahoo.com