Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tab. Inosine Pranobex 500 mg in addition with Standard of Care: [Synonyms of API: Inosine Acedoben Dimepranol (INN), Methisoprinol, Isoprinosine]
Dose: 500 mg
Route: Oral
Frequency: 2
Sponsors
Themis Medicare
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 65 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 5 on the WHO Modified 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 65 years 4.SpO2 30/minute 5.History of gout or hyperuricemia (serum uric acid level >6mg/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 |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood levels of NK cell, IL-6 and IL-10 between both treatment groups at Day 7, Day 14 and Day 21 visit.Timepoint: Day 7, 14 and 21;Mortality rate at Day 21Timepoint: Day 21;Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvement for two groups at Day 7 and Day 21Timepoint: Day 7 and Day 21;Percentage of patients with Grade 1 on WHO modified ordinal scale confirmed (negative swab status) at Day 7, Day 14 and Day 21 for two treatment armsTimepoint: Day 7, 14 and 21;Percentage of patients with Grade 2 on WHO modified ordinal scale at Day 7, Day 14 and Day 21 for two treatment armsTimepoint: Day 7, 14 and 21;Rate of patients requiring oxygen/ventilation, and/or duration of oxygen use/duration of requiring ventilation for two groups at Day 7 and Day 14Timepoint: Day 7 and 14;Severity of Dyspnea at Day 7, Day 14 and Day 21Timepoint: Day 7, 14 and 21;Time to discharge from hospital/duration of hospitalization for inpatients for two groupsTimepoint: NIL;Time to resolution of all clinical symptoms of COVID-19 viral infection (Grade 2 on WHO modified ordinal scale) for two treatment armsTimepoint: NIL;Time to RT-PCR swab negative COVID-19 viral infection (Grade 1 on WHO modified ordinal scale) for two treatment armsTimepoint: NIL;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: NIL | — |
Countries
India
Contacts
Public ContactMr Sangameshwar Iyer
Themis Medicare Ltd
Outcome results
None listed