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Study aim
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purpose of this study is to Determine the therapeutic effect of Ivermectin and Sovodak on patients infected with COVID-19.
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Design
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clinical trial with control group, with parallel groups (5 groups in sum), double blinded, randomized with Randomizer software, with 150 participants.
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Settings and conduct
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This randomized double blinded clinical trial will be implemented in Qazvin Bu Ali hospital.
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Participants/Inclusion and exclusion criteria
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1. Patients who test positive for COVID-19 by a commercially available Rapid Antigen Test (RAT) of the nasopharynx. 2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken. 3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment: o Cough o Sore throat o Headache o Nasal congestion o Feeling feverish o Body aches o Fatigue
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Intervention groups
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Control group 1: Standard regimen based on Iran health ministry, Control group 2: Standard regimen based on Iran health ministry plus Placebo, Intervention group 1: Standard regimen based on Iran health ministry plus Ivermectin (400 mcg/kg , PO, Once) and Sovodak(400/60, PO, Once), Intervention group 2: Standard regimen based on Iran health ministry plus high dose Ivermectin(400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5) and Sovodak(400/60, PO, Once), Intervention group 3: High dose Ivermectin (400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5) and Sovodak(400/60, PO, Once).
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Main outcome variables
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chest CT scan, hospitalization time, CBC and CRP