Ivermectin for Severe COVID-19 Management

• Status: Completed
• Trial end date: 2020-09-02
• Target enrollment: 0
• Participant gender: All

Summary

In this multicenter study; it was aimed to investigate the effectiveness and safety of ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no mutations which alter ivermectin metabolism and cause side effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Afyonkarahisar Health Sciences University
• Collaborator: NeuTec Pharma
• Treatments: Azithromycin; Favipiravir; Hydroxychloroquine; Ivermectin

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;

1. Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in oxygen receiving patient

2. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)

3. Mechanical ventilation requirement

4. 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.

1. Pediatric patients; <18 years of old

2. Patients with chronic liver or kidney disease

3. Pregnant women

4. Patients with known ivermectin allergy