COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62213

P Veerendra Kumar

antaryami@abiogenesisclinpharm.com

2021-11-29

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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. <br/ > <br/ > 2.Subjects with age â?¥18 years or â?¤60 years and having Body mass index (BMI) â?¥ 17.00 calculated as weight in kg/height in m2. <br/ > <br/ > 3.Clinically diagnosed patients with Coronavirus (Covid-19) infection on the basis of RT-PCR of respiratory specimen (within 48 hours prior to randomization). <br/ > <br/ > 4.Subjects with moderate COVID-19 disease as per MoH & FW guidelines, Government of India on â??Clinical Management Protocol: COVID-19â?? 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 â?¤93% on room air, Respiratory Rate more or equal to 24 per minute). <br/ > <br/ > 5.Subjects with with clinically significant elevated CRP values. <br/ > <br/ > 6.Subjects with acceptable liver function: <br/ > Alanine aminotransferase (ALT) â?¤ 1.5 X ULN <br/ > Aspartate aminotransferase (AST) â?¤ 1.5 X ULN <br/ > Bilirubin < 1.5 X ULN Alkaline phosphatase â?¤ 2.5 X ULN. <br/ > <br/ > 7.Subjects with Creatinine clearance â?¥ 30 mL/minute. <br/ > <br/ > 8.Female Subjects with negative serum/urine pregnancy test at screening.

1. Subject with known history of hypersensitivity or contraindication including anaphylaxis to Ursodeoxycholic acid to any of their components. <br/ > <br/ > 2. Subjects with any other cause of acute respiratory distress syndrome not attributable to SARS-CoV2 <br/ > <br/ > 3. Subjects with presence of any active malignancy <br/ > <br/ > 4. Subjects with potential chronic liver disease (Child Pugh A, B or C liver injury) <br/ > <br/ > 5. Subjects who received previous treatment with Ursodeoxycholic acid in last 30 days <br/ > <br/ > 6. Subjects with history of chronic use of corticosteroids and antiinflammatory agents more than 3 months at screening <br/ > <br/ > 7. Participation in other clinical trials and received drug treatment within 5 half-lives. <br/ > <br/ > 8. Subjects with Idiopathic Pulmonary Fibrosis diagnosis (based On American Thoracic Society (ATS), European Respiratory <br/ > Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) clinical practice guidelines 2018) <br/ > <br/ > 9. Subjects with history of significant pulmonary hypertension (PAH) defined by any of the following standards: <br/ > a. Clinical / echocardiographic evidence of previously significant right heart failure <br/ > b. Medical history including right heart catheter showing a cardiac index â?¤ 2 L/ min / m2 <br/ > c. Prostaglandin / Parenteral administration of prostacyclin in the treatment of PAH <br/ > <br/ > 10. Other clinically significant lung abnormalities considered by the investigator <br/ > <br/ > 11. Major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion) <br/ > <br/ > 12. Any of the following Cardiovascular diseases: <br/ > a. Severe hypertension within 6 months of screening visit, <br/ > uncontrollable after treatment (â?¥160 / 100 mmHg) <br/ > b. myocardial infarction within 6 months of screening visit <br/ > c. unstable angina within 6 months of screening visit <br/ > <br/ > 13. History of severe central nervous system (CNS) events <br/ > <br/ > 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 <br/ > the trial <br/ > <br/ > 15. Women who are pregnant, breastfeeding, or planning pregnancy during this trial <br/ > <br/ > 16. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). <br/ > <br/ > 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.

2

Shilpa Medicare Limited

18

60

India

Moderate disease at enrollment

3: Moderate disease at enrollment

48

Proportion of patients with 2-point decrease in ordinal scale <br/ >(as recommended by WHO) at Day 14Timepoint: Proportion of patients with 2-point decrease in ordinal scale <br/ >(as recommended by WHO) at Day 14

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

Phase 2

[{"arm_notes": "", "treatment_id": 2171, "treatment_name": "Ursodiol", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]