COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45359

Mridul Sharma

rajiv.salvi@piramal.com

2020-10-09

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Subjects who are able to provide a written informed consent or have a legally accepted representative to provide the same. <br/ >2. Subjects who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test. <br/ >3. Subjects who are admitted with moderate COVID-19 (MOFHW criteria) for treatment at the hospital having the following clinical criteria: pneumonia with no signs of severe disease, peripheral capillary oxygen saturation (SPO2) between 90 and 94% on room air and respiratory rate between 15 and 30 breaths per minute. <br/ >4. Subjects with arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) between 200 and 300 mm/Hg. <br/ >5. Female subjects with a negative urine pregnancy test at screening. <br/ >6. Subjects who are able to take the study drug orally and comply with the study procedures

1. Subjects who are participating in any other clinical trial or experimental treatment for COVID-19. <br/ >2. Subjects with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs. <br/ >3. Subjects requiring concomitant use of invasive or non-invasive mechanical ventilation. <br/ >4. Subjects requiring vasopressors or ionotropic medications. <br/ >5. Subjects requiring anti-viral drugs like ritonavir, favipirir, lopinavir or monoclonal antibodies like tocilizumab at hospitalization, in the opinion of the Investigator. <br/ >6. Female subjects who are pregnant or lactating. <br/ >7. Subjects who are known to be HIV positive or positive for Hepatitis B or C. (The same may be noted based on history given by the subject or standards of care followed at the individual sites.) <br/ >8. Subjects with history of retinopathy or macular degeneration. <br/ >9. Subjects with prolonged QTc interval at screening ( >450 ms in males and >470 ms in females). <br/ >10. Subjects with liver enzymes (namely alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)) > 5x upper limit of normal. <br/ >11. Subjects with creatinine clearance <50 ml/min (using Cockgroft-Gault formula). <br/ >12. Subjects who are not deemed fit as per the investigator for any other medical reason

2

Piramal Enterprises Limited

18

75

India

Severe disease at enrollment

6: Severe disease at enrollment

60

Clinical response: Resolution of fever <br/ >Clinical Improvement Scale <br/ >Overall survival of the subjects <br/ >Progression of COVID-19 associated pneumonitis <br/ >Cytokine levelsTimepoint: Clinical response: Resolution of fever - measured daily for 10 days <br/ >Clinical Improvement Scale:measured at baseline and days 3; 7 and 10 <br/ >Overall survival of the subjects: at 14 days <br/ >Progression of COVID-19 associated pneumonitis: measured daily for 10 days <br/ >Cytokine levels at baseline and on days 7 and 10

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

Phase 3

[{"arm_notes": "", "treatment_id": 1291, "treatment_name": "Tinefcon", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]