COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46240

Mr Sangameshwar Iyer

ashok.swain@themismedicare.com

2020-08-14

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Written signed and dated informed consent (patient or LAR). <br/ >2.Either gender, in the age group between 18 to 65 years <br/ >3.Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath <br/ >4.A score of between 3 to 5 on the WHO Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) <br/ >5.SpO2 â?¥90% for adults and respiratory rate â?¤ 30/minute <br/ >6.Patients who provide a agree to abide by the study requirements

1.Known hypersensitivity to any of the ingredients of the study drug <br/ >2.Pregnant and lactating women <br/ >3.Children <18 yrs. of age, elderly >65 years <br/ >4.SpO2 <90% for adults and respiratory rate >30/minute <br/ >5.History of gout or hyperuricemia (serum uric acid level >6mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction <br/ >6.Patients with history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission stage. <br/ >7.Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine. <br/ >8.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. <br/ >9.Patients simultaneously participating in another clinical study. <br/ >10.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study <br/ >11.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above

2

Themis Medicare

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for clinical improvement between two groups at day 14Timepoint: at Day 14

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

Phase 2

[{"arm_notes": "", "treatment_id": 655, "treatment_name": "Inosine pranobex", "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"}]