Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Conditions
Interventions
Intervention1: administration of drug ivermectin for patients of mild or moderate COVID and assess response on virological clearance: administration of drug ivermectin for patients of mild or moderate
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients admitted with COVID 19 , positive report, or are detected as positive after admission 2. Present within 5 days of symptom onset 3.The patient must be between the ages >5 years and 15 Kg, until 65 years of age 4.Women in child bearing age(14-50 years) within 14 days of LMP only 5.Mild-moderate symptoms at presentation as per Ministry of Family welfare, Government of India definitions
Exclusion criteria
Exclusion criteria: 1. Known history of ivermectin allergy 2. Hypersensitivity to any component of ivermectin 3. Refusal of consent (Appendix 5 and 6). 4. Co-morbidities e.g. Acute or chronic renal disease , History of coronary disease , pregnancy, History of cerebrovascular disease and malignancy 5. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Concomitant use of critical CYP3A4 substrate drugs such as warfarin. 6.Prior use of ivermectin in last 15 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OBJECTIVE To assess the Efficacy of single dose of Ivermectin, given within first 5 days of symptom onset, as assessed by RT PCR for SARS CoV 2, at 3rd and 7th day after start of treatmentTimepoint: At Admission, 3rd and 7th Day after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety profile of the drugTimepoint: Everyday for 1st 7 days;Symptom resolution as assessed everyday till 7 days of admission and progression across clinical stagingTimepoint: Everyday for 1st 7 days;Telephonic conversation at 21 day from day of administration of drug, to assess any residual symptoms.Timepoint: 21st day after administration of dose;Viral load as determined by PCR cycle threshold on Day 3 and Day 7(since ivermectin administration ).Timepoint: DAy 0, Day 3 and Day 7 | — |
Countries
India
Contacts
Public ContactROMIT SAXENA
Department of Pediatrics, Maulana Azad Medical College
Outcome results
None listed