Determining the effect of ivermectin on PCR test, clinical improvement, percentage and duration of hospitalization in outpatients with COVID-19
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 500 patients. Patients are divided into two groups by a simple randomization method with a table of random numbers. The control group will receive standard and placebo treatment and the intervention group will receive Ivermectin for three days in addition to the standard treatment.
Settings and conduct:
COVID-19 positive rapid test patients referred to family physician and infectious disease specialist are divided into two groups of intervention and control. The present study is double-blind so that patients and physicians will be unaware of how the intervention and control groups are assigned.
Participants/Inclusion and exclusion criteria:
Patients with COVID-19 positive rapid test weighing more than 15 kg are included in the study
The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Europhartech France for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg
Main outcome variables:
The primary outpoints are clinical improvement and negative PCR result after 5 days. Clinical improvement is defined as reduction in persistent cough (more than one hour of excessive coughing, or 3 periods of coughing in 24 hours that disrupts daily life and ability to work) and tachypnea and O2 saturation above 94%.