Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tab. Inosine Pranobex 500 mg: 50mg/kg/day (max 4 gm/day), 4 times in a day, Oral Administration for 10 days.
Control Intervention1: Placebo: 50mg/kg/day (max 4 gm/day), 4 times in a day
Sponsors
Themis Medicare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR). 2. Either gender, in the age group between 18 to 75 years 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 4. A score of between 3 to 4 on the Modified WHO Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) 5. SpO2 >=90% for adults and respiratory rate 6. Patients who provide a agree to abide by the study requirements
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any of the ingredients of the study drug 2. Pregnant and lactating women 3. Children 75 years 4. SpO2 30/minute 5. Known history of gout or hyperuricemia (serum uric acid level >8 mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction 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. 7. Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine. 8. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 9. Patients simultaneously participating in another clinical study. 10. Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study 11. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood levels of IL-6 and TNF-α between both treatment groupsTimepoint: at Day 6 and Day 11;Duration of oxygen use/duration of requiring ventilation for two groupsTimepoint: at Day 6 and Day 11;Mortality rateTimepoint: Day 14;Percentage and duration of hospitalization for inpatientsTimepoint: duration of hospitalization;Percentage of patients requiring oxygen inhalation (non assisted)Timepoint: Day 14;Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvement at Day 6 for two treatment armsTimepoint: Day 6;Percentage of patients with Grade 1 on modified WHO ordinal scale confirmed (negative swab status) at Day 11 for two treatment armsTimepoint: Day 11;Percentage of patients with Grade 2 on modified WHO ordinal scale at Day 6, and Day 11 for two treatment armsTimepoint: at Day 6 and Day 11;Severity of DyspneaTimepoint: Day 6 and Day 11;Time to resolution of all clinical symptoms of COVID-19 viral infection (Grade 2 on modified WHO ordinal scale) for two treatment armsTimepoint: Time to Clinical Cure;Time to two-point improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for patients in the two treatment armsTimepoint: Time to Clinical Response | — |
Countries
India
Contacts
Public ContactMr Sangameshwar Iyer
Themis Medicare Ltd
Outcome results
None listed