Ivermectin for Severe COVID-19 Management
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Ivermectin, SARS-CoV-2, Treatment
Eligibility Criteria
Inclusion Criteria:
- Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively.
Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;
- Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in oxygen receiving patient
- Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)
- Mechanical ventilation requirement
- Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure assessment) score >2
Exclusion Criteria:
Patients with the following characteristics were excluded from the study.
- Pediatric patients; <18 years of old
- Patients with chronic liver or kidney disease
- Pregnant women
- Patients with known ivermectin allergy
Sites / Locations
- Afyonkarahisar Health Science University
- Gulhane Faculty of Medicine, University of Health Sciences
- Yıldırım Beyazıt University, Ankara City Hospital
- Haydarpasa Sultan Abdulhamid Han Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Group
Study Group
Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the "COVID-19 (SARS-CoV-2 Infection) Guide" prepared by the Republic of Turkey Ministry of Health.
In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.