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Study aim:
The efficacy and safety of Ivermectin in patients with COVID-19
Design:
Controlled clinical trial with parallel groups, open-label, phase 3, 120 patients, simple randomized method
Settings and conduct:
This study will be conducted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas.The study population is 60 patients with COVID-19 (30 patients in control group and 30 in study group).
Participants/Inclusion and exclusion criteria:
Inclusion criteria: age ≥20 years old (weight ≥35 kg); positive polymerase chain reaction (PCR) test for COVID-19; non-hospitalized with mild clinical symptoms, and signed informed consent voluntarily and knowingly.
Exclusion criteria: underlying diseases (AIDS, asthma, severe liver and kidney disease); history of Loiasis; history of drug allergy to Ivermectin; use of anticoagulants (e.g. warfarin) and ACE inhibitors (e.g. captopril), and pregnancy or breastfeeding.
Intervention groups:
Group A will be mild patients receiving standard treatment of COVID-19 according to the Iran Ministry of Health's protocol.
Group B will be mild patients receiving, in addition to the standard treatment, a single dose of oral Ivermectin.
Group C will be moderate patients receiving standard treatment of COVID-19 according to the Iran Ministry of Health's protocol.
Group D will be moderate patients receiving, in addition to the standard treatment, a single dose of oral Ivermectin.
Main outcome variables:
For mild patients: clinical symptom improvement; need for hospitalization, and incidence of adverse drug reactions.
For moderate patients: length of hospital stay; need for ICU; need for mechanical ventilation, and incidence of adverse drug reactions.