COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44350

Guruprasad Palekar

maulik.doshi@sunpharma.com

2020-06-29

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

Subjects will be included in the study if they meet all of the following criteria: <br/ >1. Male or non-pregnant, non-lactating female patient aged � 18 and � 65 years <br/ >2. Patient presenting with symptoms of fever (axillary � 98.6°F or oral � 99.5°F) with <br/ >cough/shortness of breath <br/ >3. Patient with Moderate COVID -19 infection meeting the clinical criteria of (note) - <br/ >a. Pneumonia (confirmed on chest imaging) and <br/ >b. Respiratory rate 15 to 30 breaths/minute (both inclusive) and <br/ >c. Oxygen saturation- SpO2 90%-94% (both inclusive) on room air OR PaO2/ FiO2: 200- <br/ >300 mmHg (both inclusive) <br/ >4. Patient with RT-PCR confirmed diagnosis of COVID-19 <br/ >5. Patient randomized within 72 hours of diagnosis of pneumonia <br/ >6. Patient who provides written informed consent and agrees to comply with study procedures <br/ >7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry <br/ > as per MOHFW guideline <br/ >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: <br/ >1 Patient requiring extracorporeal membrane oxygenation (ECMO) or invasive ventilation <br/ >2 Patient with multiple organ failure requiring ICU monitoring and the treatment <br/ >3 Patient with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator <br/ >4 Patient with eGFR < 30 ml/min/m2 assessed with CKD EPI formula <br/ >5 Patient with Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy <br/ >6 Patient with Current or chronic history of liver disease (Child Pugh score â?¥ 10), or known hepatic or biliary abnormalities <br/ >7 Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ >8 Patient with history of chronic interstitial lung disease on imaging <br/ >9 Patient with history of hospitalization for respiratory failure within the past six months <br/ >10 Patient with history of chronic vascular disease resulting in severe exercise restriction (i.e. unable to <br/ >perform household duties) <br/ >11 Patient with history of secondary polycythemia, severe pulmonary hypertension, or ventilator dependency <br/ >12 Patient with history of vasculitis with diffuse alveolar hemorrhage <br/ >13 Patient with severe active bleeding at screening or with bleeding tendency (platelet count < 50,000/ul, INR â?¥ 3, aPTT > 65 seconds) <br/ >14 Patient with diabetes <br/ >15 Patient with any concurrent medical condition or uncontrolled, clinically significant systemic disease [e.g., heart failure (NYHA III/IV), COPD, hypertension (â?¥ 160/100 mm Hg), chronic respiratory failure, anaemia (â?¤ 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 <br/ >16 Patient with history of serology tests positive for hepatitis B or hepatitis C or human immunodeficiency virus <br/ >17 Patient with altered mental state <br/ >18 Patient with history of retinopathy or macular degeneration <br/ >19 Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency <br/ >20 Patient with prolonged QTc-interval at baseline ECG ( >450 ms in males or > 470 ms in females) <br/ >21 Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration <br/ >22 Patient requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically <br/ >23 Patient taking immunosuppressive treatment <br/ >24 Patient having history of sensitivity to heparin or heparin-induced thrombocytopenia <br/ >25 Patient with history of hypersensitivity towards any drug of standard of care or Nafamostat including their excipients <br/ >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) <br/ >27 Patient participated in trials for COVID-19 within 30 days before screening <br/ >28 Patient with hyperkalemia , i.e. serum K+ levels > 5.0 mEq/L <br/ >

2

Sun Pharmaceutical Industries Limited

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Proportion of patients showing clinical improvementTimepoint: by Day 14

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]