Evaluation of the effect of Ivermectin in treatment of outpatients with COVID-19

Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of outpatients with COVID-19 in 2021

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20111224008507N4

Enrollment

1000

Registered

2021-01-31

Start date

2021-02-19

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection. Coronavirus infection, unspecified

Interventions

Intervention 1: Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 6 mg oral tablet at a dose of 0.4 mg/kg manufactured by A

Weight 35-25, 12 mg

Weight 50-36, 18 mg

Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg. Intervention 2: Control group: In the control group, placebo tablets made by Alborz Daru company of Iran with the same shape, color and weight based d

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with positive coronavirus rapid test or RT-PCR positive No need for hospitalization Weight >15 kg Age >5 years No treatment with antiviral drugs before and during the study Informed consent for inclusion

Exclusion criteria

Exclusion criteria: Underlying liver and kidney disease Patients with acquired immunodeficiency Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Clinical improvement. Timepoint: Daily until improvement. Method of measurement: 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%.;Negative PCR result. Timepoint: 6 days after intervention. Method of measurement: RT-PCR.	—

Measure

Time frame

Clinical improvement. Timepoint: Daily until improvement. Method of measurement: 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%.;Negative PCR result. Timepoint: 6 days after intervention. Method of measurement: RT-PCR.

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Secondary

Measure	Time frame
The main complaints recovery time. Timepoint: Daily until symptoms resolve. Method of measurement: Checklist containing patient complaints.;Need to be hospitalized. Timepoint: Daily until hospitalization or improvement. Method of measurement: Percentage of hospitalization and the interval from the beginning of the intervention to hospitalization.;Mortality. Timepoint: Daily. Method of measurement: Record in checklist.;Drug side effect. Timepoint: Daily. Method of measurement: Wheezing, itching, skin rash, edema, and hypotension are assessed daily.	—

Measure

Time frame

The main complaints recovery time. Timepoint: Daily until symptoms resolve. Method of measurement: Checklist containing patient complaints.;Need to be hospitalized. Timepoint: Daily until hospitalization or improvement. Method of measurement: Percentage of hospitalization and the interval from the beginning of the intervention to hospitalization.;Mortality. Timepoint: Daily. Method of measurement: Record in checklist.;Drug side effect. Timepoint: Daily. Method of measurement: Wheezing, itching, skin rash, edema, and hypotension are assessed daily.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Sadegh Rezai

Mazandaran University of Medical Sciences

drmsrezaii@yahoo.com+98 11 3334 2334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026