COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49972

Mr Sangameshwar Iyer

ashok.swain@themismedicare.com

2021-02-01

Not recruiting

RCT

Randomized

Parallel

Blind 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 75 years <br/ >3. Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or <br/ >oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of <br/ >COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath <br/ >4. A score of between 3 to 4 on the Modified WHO Ordinal Scale for Clinical <br/ >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 >75 years <br/ >4. SpO2 <90% for adults and respiratory rate >30/minute <br/ >5. Known history of gout or hyperuricemia (serum uric acid level >8 mg/dl), <br/ >urolithiasis, nephrolithiasis or any degree of renal dysfunction <br/ >6. Patients with history of diagnosed primary congenital immunodeficiency, or <br/ >acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly <br/ >like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission <br/ >stage. <br/ >7. Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric <br/ >agents, diuretics, immunosuppressive agents or zidovudine. <br/ >8. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin <br/ >diseases. <br/ >9. Patients simultaneously participating in another clinical study. <br/ >10. Medical or psychological conditions deemed by the investigators to interfere with <br/ >successful participation in the study <br/ >11. A subject who is judged by the investigator as inappropriate to participate in the <br/ >study for any reason other than those mentioned above.

2

Themis Medicare Ltd

18

75

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

416

Clinical Response on Day 11: Percentage of patients with 2 points improvement or becoming asymptomatic on the modified ordinal scale for clinical improvement at Day 11 for two treatment arms <br/ >Clinical Response on day 6 in Non-hospitalized Patients (Co-primary endpoint): Percentages of patients with 2 points improvement or becoming asymptomatic on the modified ordinal scale for clinical improvement at Day 6 in non-hospitalized patient between the two treatment arms.Timepoint: Clinical Response on Day 6 and Day 11

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

Phase 3

[{"arm_notes": "", "treatment_id": 655, "treatment_name": "Inosine pranobex", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]