COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04646109

Nurullah Okumuş

Not reported

2020-11-27

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

2

Afyonkarahisar Health Sciences University

18

100

Turkey

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

66

Age Distribution of the Patients;Body Temperature Means of the Patients;Changes in Oxygen Saturation (SpO2) Values;Changes in Serum D-dimer Levels;Changes in Serum Ferritin Levels;Changes in Serum Lymphocyte Counts;Changes in the Ratio of Partial Pressure of Oxygen (PaO2) to Fraction of Inspired Oxygen (FiO2) (PaO2/FiO2);Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNL/L);Gender Distribution of the Patients;Genetic Examination of Haplotypes and Mutations That Cause Function Losing for Ivermectin Metabolism;Heart Rate Means of the Patients;Number of Participants With Clinical Response;Percentage of Patients With Accompanying Diseases;Percentage of Patients With Baseline Clinical Symptoms;Respiratory Rate Means of the Patients;Systolic and Diastolic Pressure Means of the Patients;Treatment-Related Adverse Events as Assessed by CTCAE v4.0

None

Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]