COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44709

Amol Pendse

Pawan.Singh@glenmarkpharma.com

2020-06-17

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures <br/ >2. Age > 18 years at the time of signing ICF <br/ >3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization) <br/ >4. Radiographic evidence of pneumonia <br/ >5. Respiratory rate > 24 breaths per minute <br/ >6. Any two of the following signs or symptoms suggestive of COVID-19: cough/shortness of breath or difficulty in breathing/fever/chills/muscle pain/sore throat/new loss of taste or smell <br/ >7. Oxygen saturation (SpO2) â?¤ 93 % on room air <br/ >8. Time interval between symptoms onset and randomization less than 10 days <br/ >9. Currently hospitalized and requiring medical care for COVID 19 <br/ >10. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum pregnancy test <br/ >11. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment, <br/ >12. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >

Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ >Inability to intake or tolerate oral medications. <br/ >Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >Gout/history of gout or hyperuricemia (above the ULN) <br/ >Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ >Known severely reduced LV function (ejection fraction <30%) <br/ >Heart rate â?¥ 125 beats per minute <br/ >Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ >Known allergy or hypersensitivity to favipiravir or umifenovir <br/ >Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ >Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ >Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, <br/ >Asthma or chronic obstructive lung disease <br/ >Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ >Pregnant or lactating women, <br/ >Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival or requirement of palliative care.

2

Glenmark Pharmaceuticals Ltd

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

158

Time from randomization to clinical cure (defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2 point improvement on WHO Ordinal Scale for Clinical Improvement) (Time frame-28 days).Timepoint: Upto 28 days

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1518, "treatment_name": "Favipiravir+umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]