Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ursodiol injection: Ursodiol injection 625mg/25ml (25mg/ml) + Standard of Care.
Dose-1750mg/day
Route -Intravenous infusion
Duration-5days
Control Intervention1: Placebo: Placebo (0.9
Sponsors
Shilpa Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 7.Subjects with Creatinine clearance ââ?°Â¥ 30 mL/minute. 8.Female Subjects with negative serum/urine pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 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 � 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 (�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 the trial 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO) at Day 14Timepoint: Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO) at Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects requiring admission to ICU, need for Invasive Mechanical Ventilation (MV) [Time Frame: 14 day] Mortality rate (All cause Death) at day 14 Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and Tumor Necrosis Factor (TNF)-alpha (Time Frame: on the day 0, 3, 5, 7, 14). Changes in fasting blood glucose levels (Time Frame: on the day 1 (before dosing), on day 7 and day 14). Changes in Liver assessment parameters for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (Time Frame: on the day 1(Before dosing) , day 7, and day 14). Time to 2-point decrease in ordinal scale (as recommended by WHO) from randomization (Time frame: at Day 3, Day 5, Day 7, and Day 14). Timepoint: 14 day 14 Day day 0, 3, 5, 7, 14 day 1 day 7 and day 14 day 1 day 7 and day 14 Day 3, Day 5, Day 7, and Day 14 | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Abiogenesis Clinpharm Private Limited
Outcome results
None listed