COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43504

Amol Pendse

Pawan.Singh@glenmarkpharma.com

2020-05-12

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/ >Age 18-75 years (inclusive) at the time of signing ICF. <br/ >Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ >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/ >Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >Additional Inclusion criteria for mild cases only: <br/ >Time interval between symptoms onset and randomization to no more than 7 days. <br/ >Pyrexia (temperature < 102.2oF), respiratory rate 12 to �20/min. <br/ >No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention, moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention, severe is defined as symptoms resulting in marked impairment of function): <br/ >Cough <br/ >Sore throat <br/ >Headache <br/ >Nasal congestion <br/ >Body aches and pains <br/ >Fatigue <br/ >Additional Inclusion criteria for moderate cases: <br/ >Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ >Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ >Patients with pyrexia (axillary � 98.6°F or oral � 99.5°F), respiratory rate > 20 to < 30/min. <br/ > <br/ >

Subjects meeting any of the following criteria must not be enrolled in the 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/ >Inability to intake or tolerate oral medications. <br/ >Severe liver disease: underlying liver cirrhosis 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/ >Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg, <br/ >Requires ICU care for management of ongoing clinical status. <br/ >Known allergy or hypersensitivity to Favipiravir, <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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.

2

Glenmark Pharmaceuticals Ltd

18

75

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

150

Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ] (Time in days from randomization to a negative SARS-CoV2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab).Timepoint: Up to 28 days

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

Phase 3

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