Evaluation of the effect of Ivermectin in the treatment of coronavirus infection

• Register: IRCT
• Last refreshed on: 13 July 2020
• Main ID: IRCT20111224008507N3
• Date of registration: 2020-06-27
• Prospective Registration: No
• Primary sponsor: Mazandaran University of Medical Sciences
• Public title: Evaluation of the effect of Ivermectin in the treatment of coronavirus infection
• Scientific title: Effectiveness of Ivermectin in the Treatment of Coronavirus Infection in Patients admitted to Educational Hospitals of Mazandaran in 2020
• Date of first enrolment: 2020-05-21
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/49174
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control with 33 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process, Blinding description: After selecting the samples, none of the participant will be aware of randomization and allocation to groups. The evaluator nurse of data recording is from out of the study and questionnaires will be provided in the form of coding to him/her. So, the present study is double-blinded.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Mohammad Sadegh Rezai
• Affiliation: Mazandaran University of Medical Sciences

• Name: Mohammadsadegh Rezai
• Affiliation: Mazandaran University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Patients hospitalized with suspected Covid-19
Informed consent for inclusion in study
Age above 5 years
Weight above 15 kg
Exclusion criteria: Liver and kidney disease
Patients with acquired immunodeficiency
Consumption of warfarin and ACEI family drugs (captopril, enalapril, etc.)
Breastfeeding

Age minimum: 5 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

COVID-19 infection.
Coronavirus infection, unspecified

B34.2

Intervention(s)

Intervention 1: Control group: In the control group, only standard drugs of the national protocol are used. Intervention 2: Intervention group: In the intervention group, along with the standard drugs of the national protocol, a single dose of 3 mg Ivermectin oral tablet with a dose of 0.2 mg/kg of Tadbir Kala Jam Company will be used according to the following table: weight 15-24, 3 mg; Weight 25-35, 6 mg; Weight 36-50, 9 mg; Weight 51-80, 12 mg and weight over 80, 0.2 mg/kg.

Primary Outcome(s)

Clinical symptoms including fever, chills, sore throat, cough, shortness of breath, decreased appetite, abdominal pain, dizziness, insomnia, itching, joint pain, joint swelling, headache, nausea, vomiting, diarrhea, malaise, conjunctivitis, tachycardia, wheezing, rhonchus, retraction, hypotension, rash, other symptoms. Timepoint: The first, second, third, fourth, fifth, sixth, seventh day. Method of measurement: Observation and record in checklist.

Respiratory rate and O2 saturation. Timepoint: The first, second, third, fourth, fifth, sixth, seventh day. Method of measurement: Pulse Oximeter.

Source(s) of Monetary Support

Mazandaran University of Medical Sciences

Ethics review

Status: Approved
Approval date: 11/04/2020
Contact:

Ethics committee of Mazandaran University of Medical Sciences