COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46873

ROMIT SAXENA

drromit@gmail.com

2020-08-26

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Patients admitted with COVID 19 , positive report, or are detected as positive after admission <br/ >2. Present within 5 days of symptom onset <br/ >3.The patient must be between the ages >5 years and 15 Kg, until 65 years of age <br/ >4.Women in child bearing age(14-50 years) within 14 days of LMP only <br/ >5.Mild-moderate symptoms at presentation as per Ministry of Family welfare, Government of India definitions <br/ >

1. Known history of ivermectin allergy <br/ >2. Hypersensitivity to any component of ivermectin <br/ >3. Refusal of consent (Appendix 5 and 6). <br/ >4. Co-morbidities e.g. Acute or chronic renal disease , History of coronary disease , pregnancy, History of cerebrovascular disease and malignancy <br/ >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. <br/ >6.Prior use of ivermectin in last 15 days <br/ >

2

not applicable

5

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

56

PRIMARY OBJECTIVE <br/ >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 <br/ >

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

Not reported

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]