A study to evaluate the efficacy and safety of Nafamostat Mesilate in treatment of Coronavirus infection
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/06/026220
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
This is an open label,randomized, multicenter, two arm, parallel, comparative, controlled study. The studywill be conducted at approximately 10-12 centers in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval.
After obtaining the informed consent, patientswill be screened via various assessments as mentioned in Schedule of Assessmentand eligible patients will be randomized in the study by allocating randomizationnumber. All randomized patients will receive either a daily dose of NafamostatMesilate (0.1 mg/kg/hr for 24 hrs as continuous infusion) with standard of careor only standard of care for 10 days. Patients will be hospitalized during thetreatment period till day of discharge. During the study, Specimen Collection,Packaging and Transport of Nasopharyngeal swab & oropharyngeal swab will bedone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- Subjects will be included in the study if they meet all of the following criteria: 1. Male or non-pregnant, non-lactating female patient aged ≥ 18 and ≤ 65 years 2. Patient presenting with symptoms of fever (axillary ≥ 98.6°F or oral ≥ 99.5°F) with cough/shortness of breath 3. Patient with Moderate COVID -19 infection meeting the clinical criteria of (note).
- a. Pneumonia (confirmed on chest imaging) and b. Respiratory rate 15 to 30 breaths/minute (both inclusive) and c. Oxygen saturation- SpO2 90%-94% (both inclusive) on room air OR PaO2/ FiO2: 200- 300 mmHg (both inclusive) 4. Patient with RT-PCR confirmed diagnosis of COVID-19 5. Patient randomized within 72 hours of diagnosis of pneumonia 6. Patient who provides written informed consent and agrees to comply with study procedures 7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry as per MOHFW guideline Note: (https://www.mohfw.gov.in/pdf/FinalGuidanceonMangaementofCovidcasesversion2.pdf).
Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1 Patient requiring extracorporeal membrane oxygenation (ECMO) or invasive ventilation 2 Patient with multiple organ failure requiring ICU monitoring and the treatment 3 Patient with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator 4 Patient with eGFR < 30 ml/min/m2 assessed with CKD EPI formula 5 Patient with Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy 6 Patient with Current or chronic history of liver disease (Child Pugh score ≥ 10), or known hepatic or biliary abnormalities 7 Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections 8 Patient with history of chronic interstitial lung disease on imaging 9 Patient with history of hospitalization for respiratory failure within the past six months 10 Patient with history of chronic vascular disease resulting in severe exercise restriction (i.e. unable to perform household duties) 11 Patient with history of secondary polycythemia, severe pulmonary hypertension, or ventilator dependency 12 Patient with history of vasculitis with diffuse alveolar hemorrhage 13 Patient with severe active bleeding at screening or with bleeding tendency (platelet count < 50,000/ul, INR ≥ 3, aPTT > 65 seconds) 14 Patient with diabetes 15 Patient with any concurrent medical condition or uncontrolled, clinically significant systemic disease [e.g., heart failure (NYHA III/IV), COPD, hypertension (≥ 160/100 mm Hg), chronic respiratory failure, anaemia (≤ 8 g/dl) etc.) that, in the opinion of the Investigator precludes the subject’s participation in the study or interferes with the interpretation of the study results 16 Patient with history of serology tests positive for hepatitis B or hepatitis C or human immunodeficiency virus 17 Patient with altered mental state 18 Patient with history of retinopathy or macular degeneration 19 Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency 20 Patient with prolonged QTc-interval at baseline ECG (>450 ms in males or > 470 ms in females) 21 Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration 22 Patient requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically 23 Patient taking immunosuppressive treatment 24 Patient having history of sensitivity to heparin or heparin-induced thrombocytopenia 25 Patient with history of hypersensitivity towards any drug of standard of care or Nafamostat including their excipients 26 Patient who participated in a clinical trial with an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) 27 Patient participated in trials for COVID-19 within 30 days before screening 28 Patient with hyperkalemia , i.e. serum K+ levels > 5.0 mEq/L.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients showing clinical improvement by Day 14
- Secondary Outcome Measures
Name Time Method Proportion of patients showing clinical improvement by Day 7 and Day 28 Time to clinical improvement upto Day 28 Time to improvement of lung imaging upto Day 28 Percent change in 24 hour PaO2/FiO2 ratio on days 7, 14, Day of discharge compared to baseline Day 7, Day 14 and Day of Discharge Time to normalization of fever without use of antipyretics in last 24 hours upto Day 28 Time to first negative SARS-CoV-2 RT-PCR in upper or lower respiratory tract specimen upto Day 28 Duration (days) of supplemental oxygen therapy upto Day 28 Proportion of patients showing deterioration of clinical condition as assessed by at least 1 point worsening on 7 point ordinal scale (non-invasive ventilation, mechanical ventilation, ECMO or death) Day 14, Day 28 Number of deaths (All cause mortality) upto Day 28 Safety evaluation, as measured by TEAEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) upto Day 28
Trial Locations
- Locations (6)
Bhatia Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Family Care Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Government Medical College and Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Kasturba Hospital for Infectious Diseases
🇮🇳Mumbai, MAHARASHTRA, India
Padmashree Dr D Y Patil Medical College Hospital & Research Center
🇮🇳Mumbai, MAHARASHTRA, India
Vijay Vallabj Hospital and Medical Research Center
🇮🇳Mumbai, MAHARASHTRA, India
Bhatia Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr SAMDANI PRATIT PRAHALADPrincipal investigator9322589110drpratit@gmail.com