COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44480

Mr Abhijit Vaidya

sandesh.sawant3@cipla.com

2020-06-10

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative. <br/ >2. Subjects of either gender and age between 18 and 75 years. <br/ >3. Confirmed diagnosis of mild to moderate COVID-19. (positivity in RTPCR <br/ >2019-nCoV test on respiratory tract specimens). <br/ >4. In case of moderate COVID-19, subjects with CT or Chest X-ray <br/ >documented pneumonia. <br/ >5. Subjects with pyrexia (axillary â?¥37â?? or oral â?¥37.5â??, or rectalâ?¥38â??) <br/ >or either respiratory rate >24/min and <30/min or cough. <br/ >6. Subjects within 7 days from symptom onset or within 48 hours of <br/ >laboratory diagnosis of SARS-CoV2. <br/ >

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ >2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ >3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ >partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ >inability to swallow the study drug or having undergone extensive <br/ >bowel resection which may affect adequate absorption of Favipiravir. <br/ >5. Subjects with gout or hyperuricemia. <br/ >6. Pregnant or breast-feeding subjects. <br/ >7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ >preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ >9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10. Subject has a psychiatric disease that is not well controlled where <br/ >controlled is defined as: stable on a regimen for more than one year. <br/ >11. Subject already treated with another COVID 19 therapy but has <br/ >relapsed with a positive diagnosis. <br/ >12. Anticipated transfer to another hospital which is not a study site <br/ >within 72 hours. <br/ >13. Participated in any other clinical trial or taken investigational drug <br/ >within 1 month. <br/ >

2

Cipla Ltd

18

75

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

156

Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]Timepoint: Up to 28 days

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

Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]