A study to evaluate the efficacy and safety of Nafamostat Mesilate in treatment of Coronavirus infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/026220
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
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 subjectâ??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
- Secondary Outcome Measures
Name Time Method