CTRI/2020/06/026220已完成2 期
An Open Label, Randomized, Multicenter, Controlled Clinical Study to Evaluate the Efficacy and Safety of Nafamostat Mesilate in the Treatment of Moderate COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
A study in preterm neonates with Respiratory Distress Syndrome (RDS) to compare CUROSURF® administration through LISA and conventional administration (LISPAP).Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.EUCTR2016-001974-14-Outside-EU/EEAChiesi Farmaceutici S.p.A.
进行中（未招募）
1 期
An international study at different study sites testing the safety and tolerability of a drug, lucinactant, which is to be inhaled as a means to treat breathing problems in babies born prematurely in the 26 to 28 weeks.Respiratory Distress Syndrome (RDS)MedDRA version: 19.1Level: LLTClassification code 10021735Term: Infant respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.1Level: LLTClassification code 10038690Term: Respiratory distress syndrome (neonatal)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.1Level: PTClassification code 10028974Term: Neonatal respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2015-005624-26-PLWindtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)64
进行中（未招募）
不适用
Proactive treatment with 0.03% tacrolimus cream in children with moderate/severe dermatitisMedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic DermatitisEUCTR2015-001040-11-Outside-EU/EEAAstellas Pharma China, Inc.120
进行中（未招募）
1 期
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with InhibitorsHaemophilia A with inhibitorsHaemophilia B with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000011928MedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000011929EUCTR2016-000510-30-GRovo Nordisk A/S26
进行中（未招募）
1 期
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with InhibitorsHaemophilia A with inhibitorsHaemophilia B with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2016-000510-30-ITOVO NORDISK. S.P.A.26