CTRI/2021/11/038307Other2 期
A Randomized, Single Blind, Placebo Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Ursodiol Injection 625mg/25ml (25mg/ml) in Adults withmoderate COVID 19 patients at a dose of 1750 mg/day via intravenous infusion.
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 16
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
- •1.Subjects willing and able to give written and dated informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study.
- •2.Subjects with age ââ?°Â¥18 years or ââ?°Â¤60 years and having Body mass index (BMI) ââ?°Â¥ 17.00 calculated as weight in kg/height in m2.
- •3.Clinically diagnosed patients with Coronavirus (Covid-19) infection on the basis of RT-PCR of respiratory specimen (within 48 hours prior to randomization).
- •4.Subjects with moderate COVID-19 disease as per MoH & FW guidelines, Government of India on ââ?¬Å?Clinical Management Protocol: COVID-19ââ?¬? as updated from time to time. i.e., pneumonia with no signs of severe disease (i.e., Adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 90 to ââ?°Â¤93% on room air, Respiratory Rate more or equal to 24 per minute).
- •5.Subjects with with clinically significant elevated CRP values.
- •6.Subjects with acceptable liver function:
- •Alanine aminotransferase (ALT) ââ?°Â¤ 1.5 X ULN
- •Aspartate aminotransferase (AST) ââ?°Â¤ 1.5 X ULN
- •Bilirubin < 1.5 X ULN Alkaline phosphatase ââ?°Â¤ 2.5 X ULN.
- •7.Subjects with Creatinine clearance ââ?°Â¥ 30 mL/minute.
- •8.Female Subjects with negative serum/urine pregnancy test at screening.
排除标准
- •1. Subject with known history of hypersensitivity or contraindication including anaphylaxis to Ursodeoxycholic acid to any of their components.
- •2. Subjects with any other cause of acute respiratory distress syndrome not attributable to SARS-CoV2
- •3. Subjects with presence of any active malignancy
- •4. Subjects with potential chronic liver disease (Child Pugh A, B or C liver injury)
- •5. Subjects who received previous treatment with Ursodeoxycholic acid in last 30 days
- •6. Subjects with history of chronic use of corticosteroids and antiinflammatory agents more than 3 months at screening
- •7. Participation in other clinical trials and received drug treatment within 5 half-lives.
- •8. Subjects with Idiopathic Pulmonary Fibrosis diagnosis (based On American Thoracic Society (ATS), European Respiratory
- •Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) clinical practice guidelines 2018)
- •9. Subjects with history of significant pulmonary hypertension (PAH) defined by any of the following standards:
- •a. Clinical / echocardiographic evidence of previously significant right heart failure
- •b. Medical history including right heart catheter showing a cardiac index ââ?°Â¤ 2 L/ min / m2
- •c. Prostaglandin / Parenteral administration of prostacyclin in the treatment of PAH
- •10. Other clinically significant lung abnormalities considered by the investigator
- •11. Major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion)
- •12. Any of the following Cardiovascular diseases:
- •a. Severe hypertension within 6 months of screening visit,
- •uncontrollable after treatment (ââ?°Â¥160 / 100 mmHg)
- •b. myocardial infarction within 6 months of screening visit
- •c. unstable angina within 6 months of screening visit
- •13. History of severe central nervous system (CNS) events
- •14. Other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in
- •15. Women who are pregnant, breastfeeding, or planning pregnancy during this trial
- •16. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •17. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
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